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Non-small cell lung cancer stage IV – Trials in Disease

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Ongoing Clinical Trials for Non-small Cell Lung Cancer Stage IV

There are currently 47 active clinical trials investigating treatments for Stage IV Non-small Cell Lung Cancer across multiple European countries. These studies are testing various therapeutic approaches including immunotherapy, targeted therapy, chemotherapy combinations, and novel drug candidates to improve outcomes for patients with advanced lung cancer.

Clinical trial locations

Study Comparing Atezolizumab Alone and Atezolizumab with Bevacizumab for First-Line Treatment in Patients with Advanced Non-Small-Cell Lung Cancer

This trial evaluates two treatment approaches for advanced non-small-cell lung cancer in patients with high PD-L1 expression. The main inclusion criteria require confirmed stage IV NSCLC diagnosis, PD-L1 expression of at least 50%, no prior chemotherapy for metastatic disease, and adequate organ function. Patients must have an ECOG performance status of 0 or 1 and at least one measurable tumor.

Exclusion criteria include having received previous treatment for advanced cancer, presence of other cancer types, serious heart problems, uncontrolled high blood pressure, active infections, pregnancy or breastfeeding, history of severe allergic reactions to similar medications, autoimmune diseases, and untreated or unstable brain metastases.

The trial compares atezolizumab alone versus atezolizumab combined with bevacizumab to determine which approach improves overall survival. Atezolizumab is an immunotherapy that helps the immune system recognize and attack cancer cells by blocking the PD-L1 protein. Bevacizumab works by blocking the growth of new blood vessels that tumors need to grow, a process called anti-angiogenesis.

Both medications are administered through intravenous infusion. The study aims to evaluate whether the combination therapy offers better outcomes compared to using atezolizumab alone in this patient population.

Study Comparing Nivolumab and Relatlimab with Chemotherapy to Pembrolizumab with Chemotherapy for Advanced Non-Small Cell Lung Cancer Patients

This umbrella study compares two treatment combinations for stage IV or recurrent non-small cell lung cancer. Main inclusion criteria include confirmed ALK-positive NSCLC, measurable disease according to RECIST v1.1, up to one previous chemotherapy treatment, life expectancy of at least 12 weeks, and ECOG performance status of 0-2. Patients can have treated brain metastases if they are not symptomatic.

The trial compares nivolumab and relatlimab with chemotherapy against pembrolizumab with chemotherapy. Nivolumab is an immune checkpoint inhibitor that blocks the PD-1 protein, while relatlimab is used in combination with nivolumab in a fixed-dose formulation. Pembrolizumab is also an immune checkpoint inhibitor. All three immunotherapy medications work by helping the immune system recognize and attack cancer cells more effectively.

The chemotherapy used includes pemetrexed, carboplatin, or cisplatin. All medications are administered through intravenous infusion. The study evaluates progression-free survival and overall survival as primary endpoints.

Study Comparing OSE2101 and Docetaxel for Patients with Metastatic Non-Small Cell Lung Cancer After Immunotherapy Resistance

This trial studies patients with metastatic NSCLC who have developed resistance to immune checkpoint inhibitors. The main inclusion criteria require patients to have stage IV NSCLC with confirmed HLA-A2 phenotype, documented resistance to anti-PD-(L)1 treatment after at least 12 weeks, ECOG performance status of 0 or 1, and at least one measurable tumor. Patients must have received at least 24 weeks of first-line treatment including anti-PD(L)1 therapy.

Exclusion criteria include not having HLA-A2 positive phenotype, not having metastatic NSCLC, age outside the specified range, or being part of a vulnerable population.

The study compares OSE2101, a cancer vaccine, with docetaxel chemotherapy. OSE2101 is designed to stimulate the immune system to target and destroy cancer cells. Docetaxel is a standard chemotherapy medication that interferes with cancer cell growth and division. OSE2101 is given as a subcutaneous injection, while docetaxel is administered through intravenous infusion.

Study for Patients with Lung or Urinary Tract Cancer Continuing Treatment with Durvalumab, Infliximab, and Mycophenolate Mofetil

This extension study allows patients who have completed a previous AstraZeneca trial and are still benefiting from durvalumab treatment to continue receiving the medication. Main inclusion criteria require that patients must have signed an informed consent form, be currently benefiting from durvalumab-based therapy as determined by their doctor, and be able to follow study requirements. The first dose in the extension study must be within 7 days of the treatment interruption window allowed by the parent study.

Exclusion criteria include having other types of cancer, not currently receiving the study treatment, having local access to the study treatment, age outside the specified range, inability to follow study procedures, medical conditions making participation unsafe, pregnancy or breastfeeding, active infections, serious heart conditions, history of other cancers within 5 years, and inability to provide informed consent.

The main medication is durvalumab, an immunotherapy drug administered as intravenous infusion at a fixed dose of 1500 mg every four weeks. Durvalumab works by blocking the PD-L1 protein on cancer cells, helping the immune system recognize and attack these cells more effectively.

Study of ABBV-400 and Budigalimab for Adults with Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

This trial evaluates the combination of ABBV-400 and budigalimab for advanced non-squamous NSCLC. Main inclusion criteria include confirmed stage IV NSCLC without actionable genomic alterations, no prior systemic therapy for advanced disease, measurable disease according to RECIST v1.1, ECOG performance status of 0 or 1, life expectancy of at least 12 weeks, and adequate organ and bone marrow function.

Exclusion criteria include prior treatment with similar medications, severe allergic reactions to study drugs, uncontrolled medical conditions, active infections, pregnancy or breastfeeding, bleeding disorders, significant heart problems, brain metastases unless treated and stable, major surgery within 4 weeks, participation in other trials within 30 days, and inability to follow study procedures.

The trial tests ABBV-400, an experimental antibody-drug conjugate, in combination with budigalimab, a monoclonal antibody that modulates the immune system. Both medications are administered through intravenous infusion. The study evaluates their safety and effectiveness in treating this type of lung cancer.

Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors

This phase I/II trial studies DS-3939a in patients with advanced solid tumors including NSCLC. Main inclusion criteria require signed informed consent, left ventricular ejection fraction of at least 50%, adequate organ function, measurable disease based on RECIST V1.1, ECOG performance status of 0 or 1, and life expectancy greater than 12 weeks. For Part 1, patients must have confirmed advanced cancer of various types including lung cancer. For Part 2, patients must have disease progression on scans during or after recent cancer treatment.

The trial evaluates the safety, tolerability, and preliminary effectiveness of DS-3939a administered as intravenous infusion. The study is divided into dose-finding and expansion phases to determine the optimal dosage and assess antitumor activity. Regular monitoring includes physical examinations, vital signs, ECGs, and imaging studies to track treatment response and safety.

Study of ifinatamab deruxtecan, raludotatug deruxtecan and docetaxel in previously treated stage IV non-small cell lung cancer patients

This umbrella study evaluates three treatment options for previously treated stage IV non-squamous NSCLC. Main inclusion criteria include confirmed advanced NSCLC with measurable disease, previous treatment with both platinum-based chemotherapy and immunotherapy with documented progression, ECOG performance status of 0-1, adequate organ function, and life expectancy of at least 3 months. Patients must be at least 18 years old and provide a tumor tissue sample.

Exclusion criteria include prior treatment with anti-cancer therapy within 14 days, history of severe allergic reactions, active or untreated brain metastases, active autoimmune disease, uncontrolled heart conditions, active infections, other active cancers requiring treatment, pregnancy or breastfeeding, and significant liver or kidney problems.

The trial compares ifinatamab deruxtecan, raludotatug deruxtecan, and docetaxel. All three medications are administered through intravenous infusion. The study monitors tumor response using RECIST criteria and tracks progression-free survival and overall survival.

Study of OSE-279 and OSE2101 Drug Combination for Patients with Advanced Solid Tumors, Lymphomas, or Metastatic Non-Small Cell Lung Cancer

This trial studies the combination of OSE-279 and OSE2101 for various cancers including metastatic NSCLC. Main inclusion criteria for Part B and C include stage IV NSCLC that cannot be treated with surgery or radiation, no specific genetic changes treatable with targeted drugs, at least one measurable tumor, ECOG performance status of 0 or 1, life expectancy greater than 3 months, and HLA-A2 genetic marker confirmed by laboratory test. Patients must not have received previous systemic treatment for stage IV disease.

Exclusion criteria include not having HLA-A2 positive phenotype, not having metastatic NSCLC or advanced solid tumors/lymphomas, and age outside the specified range.

OSE-279 is a PD-1 blocking monoclonal antibody administered through intravenous infusion every 3 or 6 weeks. OSE2101 is a cancer vaccine designed to stimulate the immune system to target cancer cells. The combination is being evaluated for safety and effectiveness, with the trial divided into three parts assessing dosing, safety, and antitumor activity.

Study of raludotatug deruxtecan, ifinatamab deruxtecan and docetaxel in patients with previously treated stage IV squamous non-small cell lung cancer

This Phase 2 umbrella study evaluates three treatment options for previously treated stage IV squamous NSCLC. Main inclusion criteria include confirmed stage IV squamous NSCLC, disease progression after two previous treatments (anti-PD-L1 immunotherapy and platinum-based chemotherapy), age 18 or older, and adequate organ function. Patients with HIV must have well-controlled disease, and those with Hepatitis B must be on antiviral treatment with no detectable virus.

Exclusion criteria include history of small cell lung cancer, previous systemic therapy for stage IV disease, active or untreated brain metastases, known autoimmune diseases, live vaccines within 30 days, active infections, severe heart conditions, pregnancy or breastfeeding, use of immunosuppressive medications, major surgery within 4 weeks, participation in other trials within 30 days, known hypersensitivity to study medications, inability to swallow oral medications, and severe liver or kidney dysfunction.

The trial compares investigational agents administered through intravenous infusion, with regular monitoring for treatment response and side effects. The study continues until 2032 with ongoing assessments of tumor response and survival outcomes.

Study of Zelenectide Pevedotin in Adults with Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer with NECTIN4 Amplification

This trial studies zelenectide pevedotin for previously treated advanced NSCLC with NECTIN4 amplification. Main inclusion criteria include age 18 or older, confirmed advanced or metastatic NSCLC with NECTIN4 gene amplification, no more than 3 previous treatments, measurable tumors according to RECIST v1.1, life expectancy of at least 12 weeks, ECOG performance status of 0 or 1, oxygen level of 93% or higher, and adequate liver, kidney, blood, and bone marrow function. Patients must provide tumor tissue samples and have negative pregnancy test if applicable.

Exclusion criteria include age below 18 or above 75, prior treatment with zelenectide pevedotin, absence of NECTIN4 amplification, current participation in other trials, known allergies, unstable brain metastases, significant heart problems, active infections, major surgery within 4 weeks, pregnancy or breastfeeding, inability to follow procedures, severe liver or kidney dysfunction, and history of other cancers within past 3 years.

Zelenectide pevedotin is an antibody-drug conjugate administered through intravenous infusion that targets NECTIN4-expressing tumor cells. The study monitors tumor response, side effects, and long-term outcomes including survival and disease progression.

Study on Maintenance Treatment with Pembrolizumab and Pemetrexed for Stage IV Non-Small Cell Lung Cancer Patients After Initial Chemotherapy and Immunotherapy

This trial evaluates maintenance therapy for stage IV NSCLC patients who have completed initial treatment. Main inclusion criteria include signed informed consent, confirmed metastatic NSCLC, PD-L1 tumor assessment, ECOG performance status of 0 or 1, no weight loss greater than 10% in last 3 months, no prior systemic anticancer therapy for advanced disease, age between 18 and 74 years, life expectancy greater than 3 months, measurable tumor disease, adequate tumor tissue for analysis, and adequate biological functions. Female participants must use contraception and have negative pregnancy test; male participants must also use contraception.

Exclusion criteria include having other types of cancer, not completing 6-month induction treatment, age outside specified range, inability to follow procedures, pregnancy or breastfeeding, other serious medical conditions, interfering medications, recent participation in other trials, known allergies, and history of substance abuse.

The trial studies pembrolizumab, an immunotherapy that helps the immune system recognize and attack cancer cells, used alone or in combination with pemetrexed chemotherapy as maintenance treatment after initial six months of combination therapy. Both medications are administered through intravenous infusion, with regular monitoring throughout the study period.

Summary

The 47 clinical trials for Stage IV Non-small Cell Lung Cancer demonstrate significant research activity across Europe, with notable concentration in countries like France, Germany, Spain, Italy, and Poland. The trials predominantly focus on immunotherapy approaches, particularly immune checkpoint inhibitors like pembrolizumab, nivolumab, and atezolizumab, often combined with chemotherapy or targeted therapies.

Several trials specifically target patients with particular genetic mutations, including ALK-positive, ROS1-positive, EGFR-mutated, and KRAS G12C-mutated NSCLC, reflecting the trend toward precision medicine. Many studies include patients with high PD-L1 expression, indicating focus on biomarker-driven treatment selection.

The trials evaluate various treatment strategies including first-line therapy, maintenance therapy after initial treatment, and options for patients who have progressed on prior treatments. Novel approaches include cancer vaccines, antibody-drug conjugates, and combinations of multiple immunotherapy agents. Several studies specifically include patients typically excluded from clinical trials, such as those with poor performance status or elderly patients, addressing important gaps in treatment evidence.

Ongoing Clinical Trials on Non-small cell lung cancer stage IV

  • Study of THIO and cemiplimab compared to chemotherapy in patients with advanced non-small cell lung cancer who have received two previous treatments

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Hungary Poland Portugal Romania

  • A study testing BNT326 and BNT327 with drug combination for safety and effectiveness in people with advanced non-small cell lung cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Italy Poland Spain

  • A Study of Amivantamab and Lazertinib for Adults with EGFR-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Finland France Germany Greece Italy +3

  • Study of raludotatug deruxtecan, ifinatamab deruxtecan and docetaxel in patients with previously treated stage IV squamous non-small cell lung cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Greece Hungary Italy Poland Spain

  • Study on the Safety and Effectiveness of BNT327 with Chemotherapy for Patients with Non-Small Cell Lung Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria France Germany Hungary Italy +3

  • Study of ABBV-400 and Budigalimab for Adults with Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy Poland Romania +1

  • Study on Osimertinib and Chemotherapy for Stage IV Non-Small Cell Lung Cancer with Atypical EGFR Mutations

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on the Effectiveness and Safety of Carboplatin, Pemetrexed, and Lorlatinib for ALK Positive Non-Small Cell Lung Cancer with Extracranial Progression

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on THIO and Cemiplimab for Patients with Advanced Non-Small Cell Lung Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Hungary Poland Romania

  • Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Spain

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