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

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Clinical Trials for Non-small Cell Lung Cancer Stage IIIB

This article provides detailed information about 21 ongoing clinical trials investigating new treatments for Non-small Cell Lung Cancer Stage IIIB. These trials are testing various medications including immunotherapy drugs, targeted therapies, and chemotherapy combinations across multiple European countries and aim to improve treatment outcomes for patients with this stage of lung cancer.

Clinical trial locations

Study Comparing Repotrectinib and Crizotinib for Patients with Advanced or Metastatic ROS1-positive Non-Small Cell Lung Cancer

This trial is comparing two oral medications for patients with advanced or metastatic ROS1-positive lung cancer. Participants must have confirmed ROS1 rearrangement, at least one measurable tumor, and no prior treatment with ROS1-targeting drugs. The study allows patients who have received up to one previous treatment for their cancer.

Main inclusion criteria: Patients must have locally advanced or metastatic disease with ROS1 gene rearrangement confirmed by testing. They should have at least one measurable tumor and an ECOG Performance Status of 0-2. Patients may have received up to one previous treatment but must not have been treated with ROS1-targeting drugs before.

Main exclusion criteria: Patients with other cancers, those who have had another cancer within the last 3 years (except certain skin cancers), and those who have received certain recent treatments are excluded. Pregnant or breastfeeding patients and those with uncontrolled heart conditions or active infections cannot participate.

Study focus: The trial aims to determine whether repotrectinib or crizotinib is more effective at preventing cancer progression. Both medications target the ROS1 protein to stop cancer cell growth. The study will track how long patients live without their cancer worsening and monitor overall survival and treatment response.

Investigational drugs: Repotrectinib and crizotinib are both tyrosine kinase inhibitors that block the ROS1 protein involved in cancer cell growth. Both are taken orally as capsules and work by targeting specific proteins that help cancer cells multiply.

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

This study tests the combination of two experimental medications for advanced non-squamous lung cancer. Participants receive both medications through intravenous infusion and must not have received prior systemic therapy for advanced disease or have certain genetic alterations.

Main inclusion criteria: Patients must have advanced or metastatic non-squamous lung cancer without targetable genetic changes. They must not have received prior systemic therapy for advanced disease, though previous treatments before or after surgery are allowed. Participants must have completed 4-6 cycles of first-line treatment and show stable or improved disease.

Main exclusion criteria: Patients with other cancer types, those with severe allergic reactions to similar medications, pregnant or breastfeeding patients, and those with uncontrolled medical conditions cannot participate. Recent participation in other trials or active infections also disqualify patients.

Study focus: The trial evaluates the safety and effectiveness of ABBV-400 combined with budigalimab to find the optimal dose for future studies. Both medications are given intravenously, with researchers monitoring how the cancer responds and tracking any side effects.

Investigational drugs: ABBV-400 is an antibody-drug conjugate that targets proteins on cancer cells, helping the immune system attack them. Budigalimab is a monoclonal antibody that enhances immune response by modulating the immune system. Both are administered by injection and are still being tested in trials.

Study of Volrustomig and Drug Combination for Patients with Early-stage Resectable Non-small Cell Lung Cancer

This trial investigates multiple medication combinations for early-stage lung cancer that can be surgically removed. Treatments are given both before surgery (neoadjuvant) and after surgery (adjuvant) through intravenous infusion.

Main inclusion criteria: Patients must have newly diagnosed resectable lung cancer at Stage IIA to IIIB with a WHO or ECOG performance status of 0 or 1. They need adequate organ and bone marrow function and must provide tumor samples for testing specific markers like PD-L1, EGFR, or ALK. Both male and female patients are eligible.

Main exclusion criteria: Patients with other cancer types, lung cancer not in early stages, cancer that cannot be surgically removed, or those who have received previous lung cancer treatments are excluded. Pregnant or breastfeeding patients and those with serious health conditions or unable to follow study procedures cannot participate.

Study focus: The study evaluates various medication combinations including volrustomig, durvalumab, and chemotherapy drugs given before and after surgery. The goal is to reduce tumor size before surgery and eliminate remaining cancer cells afterward to prevent recurrence.

Investigational drugs: Durvalumab blocks a protein that prevents the immune system from attacking cancer cells. Tremelimumab enhances immune response by targeting a protein that suppresses the immune system. Oleclumab targets proteins involved in cancer growth and spread, while monalizumab blocks proteins that inhibit immune responses, all working to boost the body’s natural cancer-fighting abilities.

Study on the Effects of Adding Durvalumab After Chemotherapy and Surgery in Patients with Resectable Non-Small Cell Lung Cancer

This study examines whether adding durvalumab after initial chemotherapy and surgery improves outcomes for patients with early-stage operable lung cancer. Patients receive combination chemotherapy and durvalumab before surgery, then some are randomized to receive additional durvalumab afterward.

Main inclusion criteria: Patients must have confirmed lung cancer that can be removed by surgery at Stage IIB-IIIB, be healthy enough for surgery, and able to receive platinum-based chemotherapy. They must have known PD-L1 status without EGFR or ALK mutations, adequate organ function, ECOG performance status 0-1, be at least 18 years old, weigh over 30 kilograms, and have a life expectancy of at least 12 weeks.

Main exclusion criteria: Patients with other cancer types, those at different stages, patients who have had lung cancer removed by surgery, or those not receiving chemo-radiotherapy are excluded. Patients outside the age range, vulnerable populations, and those unable to undergo pembrolizumab treatment cannot participate.

Study focus: The trial assesses if adding durvalumab as maintenance therapy after surgery can improve disease-free survival. Patients receive chemotherapy and immunotherapy before surgery, followed by either additional durvalumab treatment or standard follow-up care. The study tracks outcomes including disease-free survival and overall survival.

Investigational drugs: Durvalumab is an immune checkpoint inhibitor administered intravenously that works by blocking the PD-L1 protein, helping the immune system recognize and attack cancer cells. It is being studied as an adjuvant therapy following neoadjuvant chemotherapy and immunotherapy to improve disease-free survival.

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

This trial tests an experimental medication called BNT327 combined with standard chemotherapy drugs for lung cancer. The study is divided into Phase II (testing safety and dosing) and Phase III (comparing effectiveness against standard treatment).

Main inclusion criteria: Patients must provide informed consent, be at least 18 years old, have advanced lung cancer without EGFR or ALK mutations, at least one measurable tumor, ECOG performance status 0-1, life expectancy over 3 months, adequate organ function, and willingness to use effective birth control. Women of childbearing potential must have negative pregnancy tests.

Main exclusion criteria: Patients with other cancers, those who have received cancer treatment within the last 4 weeks, those with severe heart problems, uncontrolled high blood pressure, active infections, pregnancy or breastfeeding, known allergies to study drugs, severe liver or kidney disease, or recent participation in other trials are excluded.

Study focus: The study evaluates BNT327’s safety and effectiveness when combined with chemotherapy. Participants receive either BNT327 with chemotherapy or pembrolizumab with chemotherapy through intravenous infusion. Regular monitoring tracks disease progression and overall survival.

Investigational drugs: BNT327 is an investigational drug given intravenously that targets specific proteins on cancer cells to slow cancer growth. It is classified as an investigational drug still being tested for safety and effectiveness. Pembrolizumab is an approved immunotherapy that helps the immune system fight cancer by blocking proteins that prevent immune system attacks on cancer cells.

Study Comparing Ensartinib and Crizotinib for Patients with ALK-Positive Non-Small Cell Lung Cancer

This study compares two oral medications for patients with ALK-positive lung cancer. Both medications target the ALK protein that helps cancer cells grow.

Main inclusion criteria: Patients must have advanced ALK-positive lung cancer confirmed by FDA-approved testing, have received up to one previous chemotherapy treatment, have at least one measurable tumor according to RECIST v1.1, be able to follow trial procedures, be at least 18 years old, have adequate organ function including normal blood cells and liver enzymes, and have a life expectancy of at least 12 weeks with ECOG Performance Status 0-2.

Main exclusion criteria: Patients who have received more than one prior chemotherapy treatment or have been previously treated with ALK tyrosine kinase inhibitors cannot participate. Those not within the specified age range or outside the designated clinical trial groups are also excluded.

Study focus: The trial evaluates how well ensartinib and crizotinib work in controlling cancer and improving quality of life. Patients are randomly assigned to receive one medication, with regular monitoring to assess cancer response and side effects. The study measures progression-free survival and overall survival.

Investigational drugs: Ensartinib and crizotinib are both tyrosine kinase inhibitors taken orally as tablets. They work by blocking the ALK protein involved in cancer cell growth, helping to slow or stop cancer progression.

Study of sacituzumab govitecan and zimberelimab treatment before and after surgery for patients with resectable non-small cell lung cancer

This trial tests a combination of two medications given before and after surgery for lung cancer that can be surgically removed. Both medications are administered through intravenous infusion.

Main inclusion criteria: Patients must be at least 18 years old with confirmed resectable lung cancer at stages II to IIIB. They need adequate blood test results (hemoglobin ≥9 g/dL, white blood cells ≥1500/mm3, platelets ≥100,000/μL), proper liver function (bilirubin ≤1.5x normal, liver enzymes ≤2.5x normal), adequate kidney function (creatinine clearance ≥30 mL/min), good physical performance (ECOG 0-1), and must provide written consent. Women of childbearing potential must use reliable birth control.

Main exclusion criteria: Prior chemotherapy for lung cancer, active or untreated brain metastases, other cancers within past 3 years, severe heart conditions, active infections, severe liver or kidney problems, autoimmune diseases requiring treatment, pregnancy or breastfeeding, allergies to study medications, recent clinical trial participation, mental conditions affecting study participation, or any condition the doctor believes makes participation unsafe are excluded.

Study focus: The trial assesses the combination’s effectiveness at eliminating cancer cells before surgery. Treatment includes sacituzumab govitecan and zimberelimab before surgery, then zimberelimab after surgery, with some patients continuing sacituzumab govitecan. The treatment period may last up to 54 weeks with regular monitoring.

Investigational drugs: Sacituzumab govitecan is an antibody-drug conjugate that combines an antibody with anti-cancer medication, delivering treatment directly to cancer cells. Zimberelimab is an immunotherapy medication that helps the immune system fight cancer by blocking proteins that prevent immune cells from attacking cancer. Both are given intravenously.

Study on Atorvastatin’s Role in Enhancing Immunotherapy for Patients with Triple Negative Breast Cancer and Non-Small Cell Lung Cancer

This trial investigates whether adding atorvastatin (a cholesterol-lowering medication) can improve immunotherapy effectiveness for patients with breast cancer and lung cancer.

Main inclusion criteria: Patients must be able to understand and sign consent, follow scheduled visits, provide biological samples, be at least 18 years old, have ECOG Performance Status 0-1, and have adequate organ and bone marrow function. For lung cancer patients specifically, they must have stage IIIB or IV cancer without certain genetic mutations (EGFR, ALK, ROS1, BRAF, MET, RET, KRAS), high PD-L1 levels (≥50%), be eligible for first-line immunotherapy, and have an available tumor sample. If able to have children, patients must agree to use birth control throughout the study.

Main exclusion criteria: Prior allergic reactions to atorvastatin or similar drugs, active autoimmune disease requiring treatment, recent immunotherapy treatment (within 6 months), recent statin use (within 3 months), pregnancy or breastfeeding, severe liver disease, uncontrolled diabetes, active infections, other serious medical conditions, inability to swallow oral medications, major surgery within past 4 weeks, other cancer within past 5 years (with exceptions), or inability to follow study procedures are excluded.

Study focus: The study evaluates whether atorvastatin enhances immunotherapy effects. Patients are randomly assigned to receive either standard immunotherapy alone or immunotherapy plus atorvastatin 40 mg daily. Researchers collect tumor samples and blood samples to analyze immune response and cancer DNA. The trial monitors treatment effectiveness and side effects.

Investigational drugs: Atorvastatin is a statin medication taken orally that is well-established for treating high cholesterol. In this trial, researchers are investigating its potential new use alongside immune checkpoint inhibitors to enhance cancer treatment. Immune checkpoint inhibitors are immunotherapy drugs that help the immune system attack cancer cells by blocking proteins that prevent immune responses.

Study on Pembrolizumab as Maintenance Therapy for Patients with Unresectable Stage III Non-Small Cell Lung Cancer After Chemo-Radiotherapy

This study examines whether pembrolizumab given as maintenance therapy after chemotherapy and radiation can improve survival for patients with stage III lung cancer that cannot be removed by surgery.

Main inclusion criteria: Patients must provide written informed consent, be at least 18 years old, have measurable disease by RECIST 1.1, provide tumor tissue samples, have a life expectancy of at least 12 weeks, adequate blood and organ function, ECOG performance status 0-1, and be able to attend scheduled visits. Women of childbearing potential must have negative pregnancy tests and agree to use birth control. Men must also agree to use contraception.

Main exclusion criteria: Patients with other cancer types, those who have had surgery to remove lung cancer, patients not in stage IIIA-B, those not receiving chemo-radiotherapy, patients who cannot undergo pembrolizumab treatment, those outside the specified age range, and vulnerable populations are excluded.

Study focus: The trial assesses whether pembrolizumab maintenance therapy for up to 24 months after chemo-radiotherapy improves overall survival compared to observation alone. The study monitors patients over time to track cancer progression and survival outcomes.

Investigational drugs: Pembrolizumab is an immune checkpoint inhibitor administered intravenously that works by blocking the PD-1 pathway, helping the immune system recognize and attack cancer cells more effectively. It is being studied as a maintenance therapy to improve overall survival in unresectable stage III lung cancer patients who have undergone chemo-radiotherapy.

Study comparing brigatinib alone versus brigatinib with carboplatin and pemetrexed combination as first treatment for patients with advanced ALK-positive lung cancer

This study compares single medication treatment (brigatinib alone) against combination therapy (brigatinib with chemotherapy drugs) as first-line treatment for advanced ALK-positive lung cancer.

Main inclusion criteria: Patients must sign informed consent, be at least 18 years old, have advanced ALK-positive lung cancer confirmed by testing, have at least one measurable tumor, good physical condition (ECOG 0-1), adequate bone marrow function (normal blood cell counts), normal pancreas, liver, and kidney function, normal heart rhythm, recovered from previous treatments and surgery (at least 35 days), provide sufficient tumor tissue, have national health insurance, use effective birth control, be willing to attend visits, and have life expectancy of at least 12 weeks. Patients with stable brain metastases may participate if controlled with low-dose steroids.

Main exclusion criteria: History of severe allergic reactions to study medications, pregnant or breastfeeding women, active uncontrolled brain metastases, significant heart problems including uncontrolled high blood pressure or recent heart attack (within 6 months), severe liver or kidney problems, current participation in other trials, major surgery within 4 weeks, active infections, other cancers within last 3 years (except certain exceptions), interstitial lung disease, conditions making participation unsafe, inability to swallow oral medications, or known resistance to ALK inhibitors are excluded.

Study focus: The trial evaluates brigatinib alone versus brigatinib combined with carboplatin and pemetrexed. Patients receive either brigatinib tablets daily or the combination therapy. Regular health assessments track cancer response and quality of life until October 2028.

Investigational drugs: Brigatinib is an oral tyrosine kinase inhibitor that blocks the ALK protein to stop cancer cell growth. Carboplatin is a platinum-based chemotherapy drug given intravenously that interferes with cancer cell DNA. Pemetrexed is an intravenous antimetabolite chemotherapy that blocks enzymes cancer cells need for survival.

Study Comparing Ociperlimab and Tislelizumab with Pembrolizumab for Patients with Advanced Non-Small Cell Lung Cancer

This trial compares two immunotherapy combination treatments for advanced lung cancer that cannot be surgically removed or has spread to other body parts.

Main inclusion criteria: Patients must provide written consent, be at least 18 years old (or legal age of consent), have advanced lung cancer that cannot be cured with surgery or radiation, not have received previous treatment for metastatic disease, agree to provide tumor tissue, have tumor showing PD-L1 in at least 50% of cells, have at least one measurable tumor, ECOG Performance Status 0-1, normal organ function including adequate blood cells and liver/kidney function, life expectancy over 3 months, and women of childbearing potential must use reliable birth control and have negative pregnancy tests. Men must also use birth control.

Main exclusion criteria: Patients with other cancer types, those who have received previous treatments that interfere with study drugs, serious heart conditions or major health issues, pregnant or breastfeeding patients, inability to follow procedures or attend visits, known allergies to study drugs, and participation in another trial simultaneously are excluded.

Study focus: The study compares overall survival between patients receiving ociperlimab combined with tislelizumab versus pembrolizumab with placebo. Both treatment groups receive medications as intravenous infusions. The trial monitors cancer progression and quality of life.

Investigational drugs: Ociperlimab is an anti-TIGIT antibody that blocks proteins suppressing immune response, potentially enhancing cancer cell attack. Tislelizumab is a PD-1 inhibitor that helps immune cells recognize and fight cancer. Pembrolizumab is another PD-1 inhibitor that boosts immune system cancer-fighting ability. All are administered intravenously.

Summary

This collection of 21 clinical trials demonstrates a broad international research effort to improve treatment outcomes for patients with Non-small Cell Lung Cancer Stage IIIB. The trials are concentrated primarily in Western European countries, with France, Germany, Italy, and Spain hosting the most studies. Several trials are also taking place in Eastern European nations including Poland, Romania, and Hungary.

The research shows a strong focus on immunotherapy drugs, particularly pembrolizumab, durvalumab, and atezolizumab, which are being tested either alone or in various combinations with chemotherapy. Many trials are investigating targeted therapies for specific genetic mutations such as ROS1-positive, ALK-positive, and other molecular alterations. There is notable interest in combination approaches that pair immunotherapy with targeted therapies or chemotherapy to potentially enhance treatment effectiveness.

Several trials are examining perioperative approaches, testing medications both before and after surgery for resectable disease, while others focus on maintenance therapy following initial treatment. The studies generally include patients with good performance status and adequate organ function, with many requiring specific genetic testing to confirm eligibility. Most trials exclude patients with certain serious medical conditions, recent participation in other studies, or pregnancy.

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

  • Study on the Safety and Effects of ATL001 and Pembrolizumab in Adults with Advanced Non-Small Cell Lung Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Spain

  • Study on Lorlatinib for Patients with Advanced ROS1-positive Non-Small Cell Lung Cancer After First-line Treatment Failure

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of INCB099280 for Patients with Advanced Solid Tumors Who Have Not Received Immunotherapy

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Greece Hungary Romania

  • Study Comparing Repotrectinib and Crizotinib for Patients with Advanced or Metastatic ROS1-positive Non-Small Cell Lung Cancer

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria France Germany Greece Hungary Italy +4

  • Study on Atezolizumab, Bevacizumab, and Paclitaxel for Advanced Lung Cancer Patients After Immunotherapy and Chemotherapy

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

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