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

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Clinical Trials for Non-small Cell Lung Cancer Stage IIIA

There are currently 12 ongoing clinical trials investigating new treatments for Non-small Cell Lung Cancer Stage IIIA. These studies are testing various combinations of immunotherapy and chemotherapy medications, both before and after surgery, as well as for patients who cannot undergo surgical treatment. Trials are taking place across multiple European countries including Germany, France, Spain, Italy, and others.

Clinical trial locations

Study of IPH5201 and Durvalumab for Pre- and Post-Surgery Treatment in Patients with Early-Stage Non-Small Cell Lung Cancer

This trial is examining a treatment approach for patients with early-stage lung cancer that can be surgically removed, specifically stages IIA to IIIA. The study investigates the combination of two medications: IPH5201 and durvalumab, given both before and after surgery.

Inclusion criteria: Participants must be at least 18 years old with newly diagnosed, previously untreated stage IIA to IIIA lung cancer that can be surgically removed. Candidates must be suitable for specific types of lung surgery such as lobectomy or sleeve resection. Patients need to have adequate organ and bone marrow function, with normal levels of red and white blood cells, platelets, and proper liver and kidney function. A life expectancy of at least 12 weeks and body weight exceeding 35 kg are required. Tumor samples must be provided for testing specific markers like PD-L1, EGFR, or ALK.

Exclusion criteria: Patients with other types of cancer besides the specified stages, those unsuitable for surgery, individuals with serious health conditions that could interfere with the study, and pregnant or breastfeeding women cannot participate. Patients who have recently received certain treatments or are unable to follow study procedures are also excluded.

Focus: The study evaluates whether combining IPH5201 and durvalumab before and after surgery can achieve a complete response, meaning no cancer cells are found after surgery. It also examines how long patients remain cancer-free following treatment.

Investigational drugs: IPH5201 is an experimental medication being studied for its ability to help the immune system fight cancer. Durvalumab is an immunotherapy drug that helps the immune system attack cancer cells by blocking proteins that prevent this response. Both are administered through intravenous infusion.

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

This study examines multiple medication combinations for patients with early-stage lung cancer that can be removed by surgery, specifically stages IIA to IIIB. The medications include volrustomig, carboplatin, falbikitug, paclitaxel, datopotamab deruxtecan, pemetrexed, cisplatin, durvalumab, oleclumab, and monalizumab.

Inclusion criteria: Patients must have newly diagnosed resectable lung cancer at stages IIA to IIIB with a performance status of 0 or 1, meaning they are fully active or have some symptoms but can still carry out light work. Adequate organ and bone marrow function is required. Tumor samples must be provided to confirm specific cancer markers such as PD-L1, EGFR, or ALK. Adequate lung function is necessary.

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

Focus: The trial assesses the effectiveness and safety of these medication combinations when given before surgery to shrink tumors and after surgery to eliminate remaining cancer cells and reduce recurrence risk.

Investigational drugs: Durvalumab helps the immune system fight cancer by blocking PD-L1 protein. Tremelimumab boosts immune response by targeting a suppressive protein. Oleclumab targets proteins involved in cancer growth and spread. Monalizumab enhances immune system attacks on cancer cells by blocking inhibitory proteins.

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

This trial investigates whether adding durvalumab after initial chemotherapy and surgery can improve the time patients remain cancer-free. The study includes stage IIB-IIIB resectable lung cancer patients.

Inclusion criteria: Patients must have confirmed stage IIB-IIIB lung cancer that can be surgically removed. They must be healthy enough for surgery and able to receive platinum-based chemotherapy. Known PD-L1 status is required, and tumors must not have EGFR mutation or ALK translocation. Normal blood, kidney, and liver function is necessary, along with a performance status of 0-1 on the ECOG scale. Patients must be at least 18 years old, weigh more than 30 kg, and have a life expectancy of at least 12 weeks.

Exclusion criteria: Patients with other cancer types not being studied, those who have had different treatments not part of the study plan, individuals with serious health conditions, pregnant or breastfeeding women, those unable to follow procedures, recent participants in other trials, people with allergies to study medications, those with certain infections, individuals with drug or alcohol abuse history, and organ transplant recipients are excluded.

Focus: The study aims to determine if durvalumab given after initial treatment with chemotherapy and surgery can prevent cancer recurrence and improve disease-free survival.

Investigational drugs: Durvalumab is an immunotherapy medication administered through intravenous infusion. It works by blocking the PD-L1 protein, helping the immune system recognize and attack cancer cells more effectively.

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

This trial explores the investigational therapy BNT327 combined with chemotherapy drugs including paclitaxel, pembrolizumab, pemetrexed, and carboplatin. The study is divided into Phase II and Phase III.

Inclusion criteria: Participants must be at least 18 years old with confirmed stage IIIB, IIIC (unsuitable for surgery or radiotherapy), or stage IV lung cancer without specific genetic mutations (EGFR or ALK). At least one measurable tumor according to RECIST v1.1 criteria is required. An ECOG performance status of 0 or 1 is necessary, meaning fully active or having some symptoms without needing bed rest. Life expectancy must exceed 3 months with adequate organ function. Women of child-bearing potential must have negative pregnancy tests and agree to use effective birth control.

Exclusion criteria: Patients with other cancer types, those who received cancer treatment within the last 4 weeks, individuals with severe heart problems, uncontrolled high blood pressure, active infections, pregnant or breastfeeding women, those with known allergies to study drugs, individuals with severe allergic reaction history, significant liver or kidney disease, and recent participants in other clinical trials are excluded.

Focus: Phase II assesses the safety and tolerability of BNT327 at different doses with chemotherapy. Phase III compares the effectiveness of BNT327 combined with chemotherapy against pembrolizumab combined with chemotherapy.

Investigational drugs: BNT327 is being tested for its potential to treat lung cancer. Pembrolizumab helps the immune system recognize and attack cancer cells by blocking specific proteins. Both are used in combination with chemotherapy to determine which treatment provides better results.

Study of cemiplimab treatment after surgery in patients with stage II-IIIA non-small cell lung cancer who have not received chemotherapy and have PD-L1 expression of 1% or higher

This study examines patients with stage II-IIIA lung cancer who have undergone surgery and whose tumors show PD-L1 protein marker at 1% or higher. Participants have not received chemotherapy after surgery.

Inclusion criteria: Patients must be at least 18 years old with surgically removed stage II-IIIA lung cancer with clean margins. Tumors must show PD-L1 expression of 1% or higher. Patients must be fully recovered from surgery complications and either unsuitable for or have refused standard platinum-based chemotherapy due to personal choice, age (70 or older), or other health conditions. Life expectancy must be at least 3 months with properly functioning major organs. Tissue samples from previous surgery must be provided.

Exclusion criteria: Prior immunotherapy treatment, active or untreated brain or spinal cord tumors, organ transplant history, active autoimmune disease, ongoing infections requiring treatment, previous cancer treatment within the last 3 years (except certain skin cancers), known allergic reactions to similar medications, uncontrolled heart, lung, liver, or kidney disease, pregnancy or breastfeeding, inability to undergo required tests, current participation in other trials, and use of immune-suppressing medications are exclusionary.

Focus: The trial determines if giving cemiplimab after surgery can prevent cancer recurrence compared to patients receiving no additional treatment after surgery.

Investigational drugs: Cemiplimab is an immunotherapy medication and PD-1 inhibitor that blocks proteins cancer cells use to hide from the immune system, allowing natural defenses to recognize and attack cancer cells. It is administered through intravenous infusion.

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

This trial tests the combination of sacituzumab govitecan and zimberelimab given before and after surgery for patients with surgically removable lung cancer at stages II to IIIB.

Inclusion criteria: Patients must be at least 18 years old with confirmed resectable lung cancer at stages II to IIIB. Required tests include tissue sampling through airways, PD-L1 testing, and special imaging scans. Adequate blood test results are necessary, showing hemoglobin of at least 9 g/dL, white blood cell count of at least 1500/mm3, and platelet count of at least 100,000/μL. Proper liver function with bilirubin not exceeding 1.5 times normal and liver enzymes not exceeding 2.5 times normal is required. Adequate kidney function with creatinine clearance of at least 30 mL/min is necessary. Good physical performance status (ECOG score of 0-1) is required. Women who can become pregnant must use reliable birth control and not be breastfeeding.

Exclusion criteria: Prior chemotherapy for lung cancer, active or untreated brain metastases, history of other cancers within the past 3 years (except successfully treated skin cancer or early-stage cancer), severe heart conditions, active or chronic infections (hepatitis B, hepatitis C, or HIV), significant liver problems, severe kidney disease requiring dialysis, autoimmune diseases requiring systemic treatment, pregnancy or breastfeeding, known allergies to study medications, recent participation in other clinical trials, mental conditions interfering with study procedures, and conditions making participation unsafe are exclusionary.

Focus: The study determines how effective the combination is at eliminating cancer cells before surgery, with treatments given before and after surgical removal of the tumor.

Investigational drugs: Sacituzumab govitecan combines an antibody with an anti-cancer drug, targeting specific proteins on cancer cells and delivering medication directly to them. Zimberelimab is an immunotherapy medication that blocks PD-1 protein on immune cells, helping the immune system recognize and destroy cancer cells.

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

This trial focuses on stage III lung cancer that cannot be surgically removed, testing pembrolizumab as maintenance therapy after patients receive chemotherapy and radiation therapy.

Inclusion criteria: Participants must provide written informed consent and be at least 18 years old. Disease must be measurable using RECIST 1.1 criteria. Willingness to provide newly obtained tumor tissue biopsy is required. Performance status must be 0 or 1 on the ECOG scale. Adequate organ function must be demonstrated through specific tests within 10 days before treatment. Female participants of child-bearing potential must have negative pregnancy tests within 72 hours before first treatment dose and agree to use two birth control methods during the study and for 120 days after. Male participants must agree to use effective contraception from first dose through 120 days after last dose.

Exclusion criteria: Patients with other cancer types, those who had surgery to remove lung cancer, patients not in stage IIIA-B, those not receiving chemo-radiotherapy, individuals unable to undergo pembrolizumab treatment, patients outside specified age range, and members of vulnerable populations unable to give consent are excluded.

Focus: The study evaluates whether using pembrolizumab as maintenance therapy after chemotherapy and radiation can improve overall survival, comparing patients receiving pembrolizumab for up to 24 months against those under observation without additional treatment.

Investigational drugs: Pembrolizumab is an immunotherapy medication administered as intravenous infusion. It works by blocking the PD-1 pathway, helping the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor.

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

This study compares treatments for locally advanced, unresectable, or metastatic lung cancer. One group receives ociperlimab combined with tislelizumab, while another receives pembrolizumab followed by placebo.

Inclusion criteria: Patients must provide written consent, be at least 18 years old or legal age of consent, and have advanced or recurrent lung cancer that cannot be cured with surgery or radiation. No previous treatment for cancer that has spread is allowed. Tumor tissue sample must be provided for testing. Tumors must show PD-L1 protein in at least 50% of cancer cells. At least one measurable tumor according to specific guidelines is required. Good daily functioning level (ECOG Performance Status of 0 or 1) is necessary. Normal organ function based on specific blood tests is required, including adequate white blood cells, platelets, hemoglobin, normal kidney function, normal bilirubin levels (unless Gilbert’s syndrome is present), and normal liver enzyme levels. Women of child-bearing potential must use reliable birth control during the study and for at least 120 days after the last dose, with negative pregnancy tests before starting. Non-sterile men must use reliable birth control during the study and for at least 120 days after the last dose.

Exclusion criteria: Patients with other cancer types, those who had previous treatments interfering with study drugs, individuals with serious heart conditions or major health issues affecting safety, pregnant or breastfeeding women, those unable to follow procedures or attend required visits, people with known allergies to study drugs or similar medications, and participants in other simultaneous clinical trials are excluded.

Focus: The study compares overall survival of patients receiving these different treatment combinations, monitoring participants over time to assess treatment effectiveness in improving survival rates.

Investigational drugs: Ociperlimab is an experimental anti-TIGIT antibody that blocks proteins suppressing immune response, potentially enhancing the body’s ability to attack cancer cells. Tislelizumab helps the immune system recognize and fight cancer by blocking PD-1 protein. Pembrolizumab boosts the immune system’s ability to fight cancer by targeting the PD-1 protein on immune cells. All are administered as infusions.

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

This trial studies INCB099280 effects on advanced or recurrent solid tumors in patients who have not previously received immunotherapy.

Inclusion criteria: Participants must understand and sign written consent, be 18 years or older, not have received immunotherapy before, have measurable disease according to RECIST v1.1 guidelines, have ECOG performance score of 0 or 1 (up to 2 for UC patients) measuring daily living abilities, have life expectancy exceeding 3 months, and be willing to avoid pregnancy or fathering children during the study.

Exclusion criteria: Patients who already received immunotherapy, those with certain medical conditions not designed to be treated by the study, individuals not within specified age range, and members of vulnerable populations not designed to be included are excluded.

Focus: The study aims to understand the safety and tolerability of INCB099280 and its effectiveness in managing advanced solid tumors, testing different doses (400 mg, 600 mg, and 800 mg) taken twice daily.

Investigational drugs: INCB099280 is an investigational medication in film-coated tablet form, being studied for treating advanced solid tumors. The trial assesses its safety, tolerability, and potential effectiveness in patients who have not previously been treated with immune checkpoint inhibitors.

Study on Atezolizumab, Carboplatin, and Etoposide for Adults with Advanced Large-Cell Neuroendocrine Lung Cancer

This trial tests the combination of atezolizumab with chemotherapy drugs carboplatin (or cisplatin) and etoposide for large-cell neuroendocrine lung cancer.

Inclusion criteria: Patients must provide written informed consent and have confirmed diagnosis of locally advanced or metastatic large-cell neuroendocrine carcinoma of the lung without curative treatment options. If cancer has mixed types, LCNEC should be the main type (at least 50%). No previous systemic therapy is allowed, though patients who had curative treatment with cancer returning at least 6 months after stopping treatment can participate. Treatment plan must include carboplatin or cisplatin and etoposide. ECOG performance status of 0 to 2 is required. Patients must be at least 18 years old with measurable disease according to RECIST v1.1. Adequate organ function is necessary, including specific levels of liver enzymes, bilirubin, creatinine, neutrophil count, and platelet count.

Exclusion criteria: Patients who received other cancer treatment within the last 4 weeks, those with severe allergic reaction history to study drugs, individuals with active infections requiring treatment, people with other serious medical conditions, pregnant or breastfeeding women, recent participants in other clinical trials, those with other cancer history (unless in remission for at least 5 years), individuals with brain metastases (unless treated and stable), people with autoimmune diseases (unless in stable condition), and those with drug or alcohol abuse history within the last 12 months are excluded.

Focus: The study evaluates how well these treatments work together in improving survival, monitoring cancer response including changes in tumor size and time until cancer starts growing again.

Investigational drugs: Atezolizumab is an immunotherapy helping the immune system recognize and attack cancer cells. Platinum-based drugs (carboplatin or cisplatin) damage cancer cell DNA, stopping growth and division. Etoposide is chemotherapy interfering with DNA inside cancer cells. All are administered through intravenous infusion.

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

This trial explores personalized cell therapy called ATL001, designed to target specific mutations in cancer cells, examining how it works alone and combined with pembrolizumab.

Inclusion criteria: Patients must be between 18 and 75 years old at screening with life expectancy of at least 6 months at tissue collection time. Advanced lung cancer must be unresectable or metastatic, having either worsened after standard treatments or the patient cannot receive standard treatments due to side effects. Measurable disease according to specific guidelines before starting certain treatments is required. Adequate performance status (ECOG 0-1) is necessary. Before receiving study treatment, patients must have been treated with PD-1/PD-L1 inhibitor and experienced either disease progression or stable disease after at least four doses. Written informed consent is required. Confirmed diagnosis of smoking-related lung cancer is necessary. Patients must be medically fit for all procedures including blood and tumor tissue collection and receiving specific medications. Adequate organ function shown by specific blood test results is required. Women of child-bearing potential must agree to highly effective birth control during the study and for at least 12 months after treatment. Non-sterile men with female partners who can have children must use acceptable birth control from screening through at least 6 months after treatment.

Exclusion criteria: Patients with other cancer types, those outside specified age range, individuals unable to follow procedures or instructions, people with certain medical conditions interfering with the study, those taking interfering medications, pregnant or breastfeeding women, recent participants in other clinical trials, and those with allergic reaction history to study drugs are excluded.

Focus: The study assesses safety and patient tolerance of ATL001, monitoring cancer response and checking for side effects. It also compares effects with placebo, measuring changes in tumor size and overall health outcomes.

Investigational drugs: ATL001 is cell therapy using special immune T cells designed to recognize and attack cancer cells. Pembrolizumab helps the immune system detect and fight cancer cells by blocking specific proteins. The trial examines if combining them can improve treatment.

Summary

These 12 clinical trials represent a comprehensive investigation into new treatment approaches for Non-small Cell Lung Cancer Stage IIIA across Europe. The trials concentrate heavily on immunotherapy medications, particularly durvalumab, pembrolizumab, and various experimental agents, often combined with traditional chemotherapy or radiation therapy.

A significant number of trials focus on perioperative treatment strategies, examining medication combinations given both before and after surgery to improve outcomes for patients with resectable disease. Several studies target specific patient populations, including elderly or frail patients unable to undergo standard chemotherapy, and those with particular tumor characteristics such as PD-L1 expression levels.

Germany, France, Spain, and Italy appear as locations for the most trials, indicating these countries are leading centers for lung cancer research in Europe. The studies employ various approaches including comparing new drug combinations against standard treatments, testing personalized cell therapies, and evaluating different radiation therapy schedules combined with immunotherapy.

Most trials require adequate organ function, specific performance status levels, and tumor tissue samples for testing genetic markers. Common exclusion criteria across studies include pregnancy, breastfeeding, active infections, autoimmune diseases, and recent participation in other clinical trials. These ongoing investigations aim to identify more effective and better-tolerated treatment options for patients with this challenging disease.

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

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

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Spain

  • Study on the Effectiveness and Safety of Osimertinib for Patients with Stage IB-IIIA Non-Small Cell Lung Cancer After Tumor Removal

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy Poland Spain +1

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

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Greece Hungary Romania

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