Trials testing a treatment · 40 studies
Something new is being tried here: a medicine, a regimen or a procedure. If you join, you receive either the treatment under study or the standard one, and the team follows you closely.
Untreated non-squamous lung cancer with KRAS G12C mutation: adagrasib added to pembrolizumab and chemotherapy
This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation
For: Carcinoma, Non-Small-Cell Lung
9 centres: SC Memorial Healthcare International SRL, București · Cardiomed SRL Cluj-Napoca, Cluj-Napoca · Affidea Constanța, Constanța · and 6 more
Phase 3See the official record ↗NCT06875310
Original registry title
A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
Previously treated non-squamous lung cancer: telisotuzumab vedotin compared with docetaxel
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse events will be assessed.
Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of telisotuzumab vedotin or docetaxel at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 768 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 330 sites worldwide.
Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria. At the conclusion of the study, participants who continue to demonstrate clinical benefit may be eligible to receive study treatment via an extension of the study, a rollover study, or through another mechanism.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
For: Non Small Cell Lung Cancer
8 centres: Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL, Brașov · Cardiomed Srl, Cluj-Napoca · Sc Oncolab Srl, Craiova · and 5 more
Phase 3See the official record ↗NCT04928846
Original registry title
A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
First-line metastatic lung cancer with high PD-L1: ivonescimab
Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.
For: Non-Small Cell Lung Cancer
8 centres: Baia Mare · București · Cluj-Napoca · and 5 more
Phase 3See the official record ↗NCT06767514
Original registry title
Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1
First-line metastatic lung cancer with MTAP deletion: navlimetostat added to pembrolizumab and chemotherapy
The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion
For: Metastatic Non-small Cell Lung Cancer With MTAP Deletion
8 centres: Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu", București · Cluj-Napoca · Centrul de Oncologie "Sfântul Nectarie", Craiova · and 5 more
Phase 2See the official record ↗NCT07063745
Original registry title
A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion
Resectable non-small cell lung cancer without complete response: pembrolizumab with or without sacituzumab tirumotecan
This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).
For: Non Small Cell Lung Cancer
7 centres: SC ONCO CARD SRL, Brașov · MEMORIAL HEALTHCARE INTERNATIONAL S.R.L., București · Cardiomed SRL Cluj-Napoca-Medical Oncology, Cluj-Napoca · and 4 more
Phase 3See the official record ↗NCT06312137
Original registry title
A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)
Metastatic squamous lung cancer: pembrolizumab with or without sacituzumab tirumotecan maintenance
This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).
For: Non-small Cell Lung Cancer, NSCLC
7 centres: SC ONCO CARD SRL, Brașov · Centrul Medical Medicover Victoria, București · Cardiomed SRL Cluj-Napoca, Cluj-Napoca · and 4 more
Phase 3See the official record ↗NCT06422143
Original registry title
Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]
Lung cancer: BNT327 alongside chemotherapy and other investigational medicines
This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC).
This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.
For: Non-small Cell Lung Cancer
7 centres: Coltea Clinical Hospital, București · Cardiomed, Cluj-Napoca · Onco Clinic Consult SA, Craiova · and 4 more
Phase 2See the official record ↗NCT06712316
Original registry title
Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer
Untreated small cell lung cancer: BNT327 alongside chemotherapy
This is a Phase III, multisite, randomized, double-blinded study to investigate pumitamig (BNT327) combined with chemotherapy (etoposide/carboplatin) compared to atezolizumab combined with chemotherapy (etoposide/carboplatin) for the treatment of participants with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).
For: Extensive-stage Small-cell Lung Cancer
7 centres: SC Oncopremium Team SRL, Baia Mare · Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti (IOB), București · Cardiomed, Cluj-Napoca · and 4 more
Phase 3See the official record ↗NCT06712355
Original registry title
Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer
Previously treated extensive-stage small cell lung cancer: sacituzumab govitecan compared with standard care
The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC).
The primary objectives of this study are to compare the effect of SG to SOC on overall survival (OS).
For: Extensive Stage Small Cell Lung Cancer (ES-SCLC)
7 centres: Bucharest Oncology Institute Professor Doctor Alexandru Trestioreanu, București · S.C Radiotherapy Center Cluj S.R.L, Cluj-Napoca · S.C Centrul de Oncologie S.F Nectarie SRL, Craiova · and 4 more
Phase 3See the official record ↗NCT06801834
Original registry title
Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer
First-line metastatic lung cancer with high PD-L1: rilvegostomig compared with pembrolizumab
The purpose of ARTEMIDE-Lung04 is to assess the efficacy and safety of rilvegostomig compared with pembrolizumab monotherapy as 1L treatment in participants with mNSCLC and whose tumors express PD-L1.
For: Carcinoma, Non-Small Cell Lung
7 centres: București · Craiova · Iași · and 4 more
Phase 3See the official record ↗NCT06868277
Original registry title
A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer
Untreated advanced lung cancer with high PD-L1: pumitamig compared with pembrolizumab
The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%.
For: Non-Small Cell Lung Cancer (NSCLC)
7 centres: Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu, Baloteşti · Centrul de Diagnostic si Tratament Provita, București · Institutul Oncologic Cluj, Cluj-Napoca · and 4 more
Phase 3See the official record ↗NCT07361510
Original registry title
A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)
First-line advanced non-squamous lung cancer: sotorasib with chemotherapy compared with pembrolizumab with chemotherapy
The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.
For: Non-Small Cell Lung Cancer (NSCLC)
6 centres: Institutul Oncologic, Prof Dr Alexandru Trestioreanu, București · Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca, Cluj-Napoca · Centrul de Oncologie Sf Nectarie SRL, Craiova · and 3 more
Phase 3See the official record ↗NCT05920356
Original registry title
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
KRAS G12C-mutated lung cancer with high PD-L1: calderasib alongside pembrolizumab
This is a study evaluating the efficacy and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There are two primary study hypotheses:
Hypothesis 1: Combination of calderasib and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
Hypothesis 2: Combination of calderasib plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS).
For: Non-small Cell Lung Cancer
6 centres: SC ONCO CARD SRL, Brașov · Centrul de Diagnostic si Tratament Provita, București · Institutul Oncologic Cluj-Oncologie Medicala, Cluj-Napoca · and 3 more
Phase 3See the official record ↗NCT06345729
Original registry title
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Advanced HER2-mutated lung cancer: sevabertinib compared with standard treatment
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC means lung cancer that has spread nearby or to other parts of the body or is unlikely to be controlled with current treatments. HER2 is a protein that helps cells to grow and divide. Sometimes, cancer cells have a damaged HER2 gene. This is called a mutation. This mutation can lead to an abnormal HER2 protein which may cause cancer cells to grow and divide too quickly.
The study treatment, sevabertinib, is designed to block the mutated HER2 protein and may help slow or stop the cancer from growing.
The main purpose of this study is to find out how well sevabertinib works and how safe it is, compared with standard treatment in participants with advanced NSCLC with a HER2 mutation.
The study participants will receive one of the study treatments:
* Sevabertinib as a tablet taken by mouth twice a day
* Standard approved treatment for this condition given by infusion into a vein every 21 days Participants will continue their assigned treatment for as long as they benefit from it and do not experience severe side effects, or until they or their doctor decide to stop treatment. When a participant assigned to the standard treatment has their cancer gets worse, they may have the opportunity to switch to receive sevabertinib. This switch is called a crossover.
Participants who switch to sevabertinib will continue this treatment until their disease gets worse again, they have side effects that are too severe, or they or their doctor decide to stop treatment.
During the study, the research team will:
* do scans such as CT, PET, MRI, or X-rays to check the cancer
* Check the overall health of the participants by performing tests such as blood and urine tests and checking heart health using an electrocardiogram and echocardiogram.
* do pregnancy tests when needed
* ask how the participants are feeling and whether they have had any adverse events or other health problems An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
For: Advanced Non-small Cell Lung Cancer, HER2 Mutation
6 centres: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu (IOB); Oncologie Medicală II, București · CardioMed S.R.L., Cluj-Napoca · Sc Oncolab Srl, Craiova · and 3 more
Phase 3See the official record ↗NCT06452277
Original registry title
A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Stage IV PD-L1-positive non-squamous lung cancer: nivolumab and relatlimab with chemotherapy compared with pembrolizumab with chemotherapy
The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 expression ≥ 1%
For: Non-small Cell Lung Cancer
6 centres: SC Memorial Healthcare International SRL, București · Institutul Oncologic Cluj, Cluj-Napoca · Centrul de Oncologie "Sfântul Nectarie", Craiova · and 3 more
Phase 3See the official record ↗NCT06561386
Original registry title
A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%
Lung cancer with high PD-L1: sigvotatug vedotin alongside pembrolizumab
The purpose of the study is to compare how the new combination treatment (Sigvotatug Vedotin plus pembrolizumab) works compared to pembrolizumab alone in patients with non-small cell lung cancer (NSCLC) with high levels of PD-L1. This is a protein that acts as a kind of "brake" to keep the body's immune responses under control.
The study is seeking for participants who:
* Are confirmed to have NSCLC (Stage 3 or 4).
* Have PD-L1 levels in more than 50% of the cancer cells.
All participants in this study will receive pembrolizumab at the study clinic once every 6 weeks as an intravenous (IV) infusion (give directly into a vein). In addition, half of the participants will also receive Sigvotatug Vedotin once every 2 weeks as an IV infusion in addition to receiving pembrolizumab.
Participants may receive pembrolizumab for up to about two years. Those participants taking Sigvotatug Vedotin can continue until their NSCLC is no longer responding. The study team will monitorsee how each participant is doing with the study treatment during regular visits at the clinic.
For: Non-Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung, Carcinoma, Non-Small-Cell Lung (NSCLC)
6 centres: SC Memorial Healthcare International SRL, București · SC Medisprof SRL, Cluj-Napoca · SC Oncolab SRL, Craiova · and 3 more
Phase 3See the official record ↗NCT06758401
Original registry title
This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1.
First-line HER2-overexpressing lung cancer: trastuzumab deruxtecan with pembrolizumab and chemotherapy
This clinical trial is designed to assess the efficacy and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS \<50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting.
For: Non-small Cell Lung Cancer
6 centres: Delta Health Care S.R.L, București · Institutul Oncologic, Cluj-Napoca · Centrul de Oncologie Sfantul Nectarie Craiova, Craiova · and 3 more
Phase 3See the official record ↗NCT06899126
Original registry title
Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer
Relapsed small cell lung cancer: GSK5764227, a medicine under study
In this study researchers are testing Risvutatug rezetecan also known as (Ris-Rez) a new medicine that targets specific proteins (B7-H3) on cancer cells, thereby reducing the cancer's ability to grow and spread. This study specifically aims to evaluate how well Ris-Rez works in treating relapsed SCLC compared to standard treatment topotecan, by checking whether Ris-Rez makes cancers smaller or disappear completely and if it helps participants live longer. The study is also assessing whether Ris-Rez is safe and tolerated well by participants compared to topotecan and provide a better understanding of the main side effects of both drugs. Participants with relapsed SCLC will be randomly divided into two groups: one group receiving Ris-Rez and the other receiving topotecan.
For: Neoplasms, Lung
6 centres: GSK Investigational Site, Cluj-Napoca · GSK Investigational Site, Craiova · GSK Investigational Site, Craiova Dolj · and 3 more
Phase 3See the official record ↗NCT07099898
Original registry title
A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)
Non-small cell lung cancer: calderasib and other treatments, tested across several groups
Researchers want to learn if the study medicines calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation.
The goal of this study is to learn if people who receive calderasib with SC pembrolizumab live longer without the cancer growing or spreading than in people who receive SC pembrolizumab with chemotherapy.
For: Non-small Cell Lung Cancer
6 centres: SC ONCO CARD SRL, Brașov · Spitalul Clinic Colțea, București · Institutul Oncologic Prof. Dr. I Chiricuta, Cluj-Napoca · and 3 more
Phase 3See the official record ↗NCT07190248
Original registry title
A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)
Unresectable stage III lung cancer after chemoradiation: pumitamig compared with durvalumab
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
For: Non-small Cell Lung Cancer (NSCLC)
6 centres: Centrul de Diagnostic si Tratament Provita, București · Institutul Oncologic Cluj, Cluj-Napoca · Centrul de Oncologie Sf. Nectarie SRL, Craiova · and 3 more
Phase 3See the official record ↗NCT07361497
Original registry title
A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)
First-line advanced lung cancer: imzokitug added to pumitamig and platinum chemotherapy
The purpose of this study is to assess the safety, tolerability, and efficacy of Imzokitug in combination with Pumitamig and Platinum-Doublet Chemotherapy (PDCT) versus Pumitamig and PDCT as first-line treatment for participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
For: Locally Advanced Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer (NSCLC)
6 centres: București · Cluj-Napoca · Craiova · and 3 more
Phase 2See the official record ↗NCT07680764
Original registry title
A Study To Assess the Safety, Tolerability, and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
KRAS G12C-mutated lung cancer: adagrasib alone and with pembrolizumab
The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.
The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \>=50% and who are candidates for first line treatment.
For: Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
5 centres: Institutul Oncologic Bucuresti - Prof. Dr. Alexandru Trestioreanu, București · Medisprof, Cluj-Napoca · Centrul de Radioterapie Amethyst Cluj, Florești · and 2 more
Phase 2See the official record ↗NCT04613596
Original registry title
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
First-line advanced KRAS G12C-mutated lung cancer: olomorasib and pembrolizumab, with or without chemotherapy
The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.
For: Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
5 centres: Lotus-Med, București · Institutul Oncologic, Cluj-Napoca · Centrul de Oncologie "Sfântul Nectarie", Craiova · and 2 more
Phase 3See the official record ↗NCT06119581
Original registry title
A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer
First-line extensive-stage small cell lung cancer: BMS-986489 with chemotherapy compared with atezolizumab with chemotherapy
The Purpose of the Study is to Compare the Efficacy and Safety of BMS-986489 (Anti-fucosyl-GM1+ Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide to that of Atezolizumab with Carboplatin plus Etoposide as First-Line Therapy in Participants with Extensive-Stage Small Cell Lung Cancer.
For: Extensive-Stage Small Cell Lung Cancer
5 centres: București · Cluj-Napoca · Craiova · and 2 more
Phase 3See the official record ↗NCT06646276
Original registry title
A Study to Compare the Efficacy and Safety of BMS-986489 (Atigotatug+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).
Previously treated advanced lung cancer with MTAP deletion: navlimetostat
The purpose of this study is to evaluate the safety and efficacy of Navlimetostat (BMS-986504) monotherapy in participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with homozygous MTAP deletion after progression on prior therapies.
For: Carcinoma, Non-Small-Cell Lung
5 centres: Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu", București · Institutul Oncologic Cluj, Cluj-Napoca · Centrul de Oncologie "Sfântul Nectarie", Craiova · and 2 more
Phase 2See the official record ↗NCT06855771
Original registry title
A Study of Navlimetostat (BMS-986504) in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion (MountainTAP-9)
EGFR-mutated lung cancer after targeted therapy failure: izalontamab brengitecan compared with chemotherapy
A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy
For: Non-Small Cell Lung Cancer
5 centres: București · Cluj-Napoca · Craiova · and 2 more
Phase 2See the official record ↗NCT07100080
Original registry title
Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)
Relapsed small cell lung cancer: ifinatamab deruxtecan compared with the doctor's choice of treatment
This study is designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).
For: Small Cell Lung Cancer
4 centres: S.C Radiotherapy Center Cluj S.R.L, București · Institutul Oncologic 'Prof. Dr. Ion Chiricuta' Cluj Napoca, Cluj-Napoca · S.C Centrul de Oncologie Sfantul Nectarie Craiova, Craiova · and 1 more
Phase 3See the official record ↗NCT06203210
Original registry title
A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
Non-small cell lung cancer: pembrolizumab with or without intismeran autogene
The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).
For: Carcinoma, Non-Small-Cell Lung
4 centres: S.C. ONCO CARD S.R.L, Brașov · Centrul Medical Medicover Victoria, București · Institutul Regional de Oncologie, Iași · and 1 more
Phase 3See the official record ↗NCT06623422
Original registry title
A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
First-line metastatic lung cancer: visugromab added to immunochemotherapy
This is an exploratory, signal finding, randomized, placebo-controlled, blinded, multi-center Phase 2b trial of the anti GDF-15 antibody Visugromab (CTL-002) versus Placebo, combined with Immunochemotherapy (ICT: Pembrolizumab, Pemetrexed, Carboplatin) in the first-line treatment of participants with newly diagnosed metastatic non-squamous NSCLC. The trial consists of 3 Parts, a non-randomized Safety-run-in part (Part A) and the subsequent randomized Ph2b trial with 2 treatment arms. After the treatment of 15 participants with visugromab at the expansion dose, an interim safety and preliminary efficacy analysis will be conducted (Part B), followed by the treatment of the remaining participants (Part C).
For: Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adult Solid Tumor
4 centres: "Sf. Nectarie" Oncology Center, Department of Medical Oncology, Craiova · Gral Medical S.R.L. - Oncofort Hospital, Pitești · Clinica Polisano S.R.L., Sibiu · and 1 more
Phase 2See the official record ↗NCT07098988
Original registry title
Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC
Lung cancer with secondary resistance to immunotherapy: OSE2101, a therapeutic vaccine
Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance.
Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification factors will be histology (squamous versus non squamous) and ECOG Performance Status (0 versus 1).
For: Patients With Non-Small Cell Lung Cancer
3 centres: Institutul Oncologic Prof. Dr. Ion Chiricuta, Cluj-Napoca · Centrul de Oncologie Sf Nectarie, Craiova · SC OncoMed SRL, Timișoara
Phase 3See the official record ↗NCT06472245
Original registry title
Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
Untreated advanced non-squamous lung cancer without targetable mutations: telisotuzumab adizutecan with immunotherapy
Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide. The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death receptor 1 (PD1) immune checkpoint inhibitor to adult participants to treat NSCLC.
Telisotuzumab Adizutecan (ABBV-400) and budigalimab are investigational drugs being developed for the treatment of NSCLC. This study will be divided into two stages, with the first stage treating participants with several doses of telisotuzumab adizutecan in combination with budigalimab within the dose escalation regimen until the dose reached is tolerable and expected to be efficacious. In Stage 2 there will be 3 treatment groups. Two groups will receive pembrolizumab with different optimized doses of telisotuzumab adizutecan (to allow for the best dose to be studied in the future). One group will receive the standard of care (SOC) - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. Approximately 252 adult participants with NSCLC will be enrolled in the study in 132 sites worldwide.
In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of Telisotuzumab Adizutecan in combination with budigalimab until the dose of Telisotuzumab Adizutecan reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive IV optimized doses of Telisotuzumab Adizutecan in combination with IV pembrolizumab, or IV SOC - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. The study will run for a duration of approximately 33 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
For: Non Small Cell Lung Carcinoma
3 centres: MNT Healthcare Europe SRL, București · Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca, Cluj-Napoca · Clinica MedLife Polisano Sibiu, Sibiu
Phase 1See the official record ↗NCT06772623
Original registry title
Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations
Resected or unresectable KRAS G12C-mutated lung cancer: olomorasib added to standard care
The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.
For: Carcinoma, Non-Small-Cell Lung
3 centres: Lotus-Med, București · Institutul Oncologic, Cluj-Napoca · Ovidius Clinical Hospital OCH, Ovidiu
Phase 3See the official record ↗NCT06890598
Original registry title
Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer
Stage II-IIIB HER2-mutated lung cancer after surgery: zongertinib compared with standard treatment
Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can improve outcomes compared with standard adjuvant treatment in adults with completely resected Stage II-IIIB non-small cell lung cancer (NSCLC) whose tumors have activating HER2 tyrosine kinase domain (TKD) mutations. Eligible participants must have undergone curative-intent surgery and received guideline-appropriate perioperative systemic therapy, either neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy.
Participants are randomized 1:1 to receive zongertinib or standard of care, which may consist of approved adjuvant immunotherapy or active surveillance, based on local practice guidelines. The main purpose of the study is to determine whether zongertinib can prolong disease-free survival compared to standard treatment. Safety and patient-reported outcomes are also assessed.
For: Non-small Cell Lung Cancer
3 centres: Lotus Med, București · Ovidius Clinical Hospital S.R.L, Ovidiu · Polaris Medical S.A., Suceagu/ Cluj Napoca
Phase 3See the official record ↗NCT07195695
Original registry title
Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations
Second-line metastatic lung cancer: visugromab and nivolumab, with or without docetaxel
This is an exploratory, signal-finding, randomized, placebo-controlled, blinded, multi-center phase 2b trial of the anti-GDF-15 antibody Visugromab (CTL-002) at two different dose levels plus Nivolumab with Docetaxel versus Visugromab at the higher dose plus Nivolumab with placebo versus double-placebo with Docetaxel, in participants that receive second-line treatment for non-squamous NSCLC after failure of prior first-line treatment including a CPI (checkpoint inhibitor).
The trial consists of 3 Parts: an open-label Safety Run-in part (Part A) followed by a subsequent randomized phase 2b part with 4 treatment arms. After the treatment of 15 participants with visugromab at the expansion dose, an interim safety and preliminary efficacy analysis will be conducted (Part B), followed by the treatment of the remaining participants (Part C).
For: Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adult Solid Tumor
3 centres: Sf. Nectarie Oncology Center, Craiova · Clinica Polisano S.R.L, Sibiu · SC Oncomed SRL, Timișoara
Phase 2See the official record ↗NCT07246863
Original registry title
Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC
Advanced small cell lung cancer: obrixtamig added to atezolizumab and chemotherapy, compared with standard chemotherapy
This study is open to adults with advanced small cell lung cancer (SCLC). The purpose of this study is to find out if a study medicine called obrixtamig plus standard treatment (atezolizumab, carboplatin, and etoposide) improves survival when compared to standard treatment alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker DLL3.
Participants are put into 2 groups randomly, which means by chance. One group receives obrixtamig and standard treatment. The other group receives standard treatment without obrixtamig. All treatments are given as infusions into a vein.
Participants are in the study for up to 3 years. During this time, they visit the study site regularly. Participants in the group receiving obrixtamig stay overnight at the study site following the first 2 obrixtamig treatments. At the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
For: Small Cell Lung Cancer (SCLC), Extensive-stage Small Cell Lung Cancer (ES-SCLC)
3 centres: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti, București · Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca, Cluj-Napoca · Centrul De Oncologie SF Nectarie S.R.L., Craiova
Phase 3See the official record ↗NCT07472517
Original registry title
DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemoimmunotherapy
Advanced lung cancer, third line: THIO with cemiplimab compared with chemotherapy
THIO is a first-in-class small molecule telomere targeting agent, in development for the treatment of non-small cell lung cancer (NSCLC) in combination with cemiplimab (LIBTAYO®). THIO is preferentially incorporated into telomeres sequence in telomerase-positive cells leading to rapid telomere uncapping, genomic instability, and cell death.
Cemiplimab is a programmed cell death protein 1 (PD-1) inhibitor recently approved as a first-line treatment for patients with locally advanced or metastatic NSCLC with 50% or more PD-L1 expression. It is hypothesized that THIO administration prior to cemiplimab would restore tumor responses to immunotherapy in subjects who either developed resistance or relapsed after receiving first line treatment with an immune check point inhibitor.
For: Carcinoma, Non-Small -Cell Lung
2 centres: Oncolab S.R.L., Craiova · Spitalul Clinic Municipal de Urgenta Timisoara/ Clinica de Oncologie Medicala, Timișoara
Phase 3See the official record ↗NCT06908304
Original registry title
A Phase III Study With THIO + Cemiplimab vs Chemotherapy as 3rd Line Treatment in Advanced/Metastatic NSCLC
Relapsed or refractory small cell lung cancer: BMS-986525 alone and in combination
The purpose of this study is to assess the safety and tolerability of BMS-986525 alone and in combination with Pumitamig in participants with Relapsed/Refractory Small Cell Lung Cancer
For: Relapsed/Refractory Small Cell Lung Cancer
2 centres: Centrul de Oncologie Sf. Nectarie SRL, Craiova · Oncohelp Medical Center, Timișoara
Phase 1See the official record ↗NCT07325136
Original registry title
A Study to Assess the Safety and Tolerability of BMS-986525 Alone and in Combination Therapy in Participants With Relapsed/Refractory Small Cell Lung Cancer
Platinum-resistant ovarian cancer or relapsed lung adenocarcinoma: first-in-human test of TUB-040
The purpose of this multicenter, open label trial (NAPISTAR 1-01) is to evaluate the safety/tolerability, pharmacokinetics and preliminary efficacy of TUB-040 and to find the best dose of TUB-040 in participants with ovarian cancer and Non Small Cell Lung Cancer. TUB-040 is an antibody-drug-conjugate which delivers a topoisomerase I inhibitor to tumor cells which overexpress the target NaPi2b. The study consists of three parts: In dose escalation, ovarian cancer participants and lung cancer participants receive increasing doses of TUB-040 until the maximal tolerated dose is found. In dose optimization, at least two doses are compared with each other to determine which dose is optimal for participants. In dose expansion, a single dose will be used in a larger number of participants.
TUB-040 is given IV every 3 weeks until the disease progresses or the participants has to stop due to side effects.
For: Ovarian Cancer, Non-small Cell Lung Cancer
One centre: Arensia Exploratory Medicine, Cluj-Napoca
Phase 1See the official record ↗NCT06303505
Original registry title
FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
Advanced EGFR-mutated lung cancer: Dato-DXd with or without osimertinib compared with platinum chemotherapy
This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS).
For: Metastatic Non-small Cell Lung Cancer
One centre: Craiova
Phase 3See the official record ↗NCT06417814
Original registry title
A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Advanced solid tumours: YL201 alongside other cancer treatments
This is a phase Ib/II, multicenter, open-label study of YL201 combined with atezolizumab. The study will include 2 parts. Part 1 of the study is a dose escalation in participants with previously untreated ES-SCLC to determine the safety and tolerability of YL201 in combination with fixed dose of atezolizumab. The planned dose levels of YL201 are 1.2 mg/kg, 1.6 mg/kg and 2.0 mg/kg. Part 2 consists of a dose optimization stage followed by a dose expansion stage. During the dose optimization stage, participants will be randomized 1:1:1 to receive either YL201 at 1.2 mg/kg,1.6 mg/kg or 2.0 mg/kg Q3W in combination with fixed dose of atezolizumab. The decision to initiate the dose expansion stage in Part 2 and choose one or two of the YL201 dose level(s) will be based on the review of safety, PK, and efficacy from the dose optimization stage. Treatment will continue until disease progression, unacceptable toxicity, or withdraw of consent.
For: Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma
One centre: Craiova
Phase 1See the official record ↗NCT07407933
Original registry title
A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors
Source: ClinicalTrials.gov, the public registry of the US National Library of Medicine. Data retrieved on 15 Sept 2026.
