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Squamous cell carcinoma of lung – Trials in Disease

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Ongoing Clinical Trials for Squamous Cell Carcinoma of Lung

There are currently 9 clinical trials ongoing for squamous cell carcinoma of lung (also known as squamous non-small cell lung cancer, metastatic squamous NSCLC). These trials are testing various combinations of immunotherapy, chemotherapy, and investigational drugs across multiple European countries, with the goal of finding more effective treatments for this type of lung cancer that has spread to other parts of the body.

Clinical trial locations

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

This trial is designed for patients with metastatic non-small cell lung cancer who have a specific genetic marker called HLA-A2 and whose cancer has returned after initial treatment with immunotherapy. The study compares a cancer vaccine called OSE2101 with the standard chemotherapy drug docetaxel.

Main inclusion criteria: Participants must be at least 18 years old with confirmed HLA-A2 phenotype. They must have metastatic non-small cell lung cancer that has progressed after at least 24 weeks of first-line treatment, including at least 12 weeks of anti-PD(L)1 therapy. Patients should have an ECOG performance status of 0 or 1, meaning they can carry out most daily activities. They must have measurable cancer lesions and adequate organ function.

Main exclusion criteria: Patients without the HLA-A2 positive phenotype cannot participate. Those who do not have metastatic non-small cell lung cancer or are not within the specified age range are excluded. Vulnerable populations requiring special protection also cannot join.

Trial focus: The study aims to determine which treatment helps patients live longer. Participants are randomly assigned to receive either the OSE2101 vaccine as a subcutaneous injection or docetaxel as an intravenous infusion. The trial runs for up to 24 months with regular monitoring by the research team.

Investigational drugs: OSE2101 is a cancer vaccine designed to stimulate the immune system to recognize and attack cancer cells. Docetaxel is a standard chemotherapy drug that interferes with cancer cell growth and division.

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

This trial tests DS-3939a, a new treatment given as an intravenous infusion for patients with advanced solid tumors that have spread beyond their original location and are difficult to treat.

Main inclusion criteria: Participants must sign an informed consent form and have a left ventricular ejection fraction of at least 50%. They need adequate organ function, measurable disease according to RECIST V1.1 criteria, and an ECOG performance status of 0 or 1. For Part 1, patients must have confirmed locally advanced, metastatic, or unresectable cancer in specific organs regardless of cancer type. For Part 2, patients need confirmed diagnosis meeting study criteria with disease progression on recent treatment and must provide a baseline tumor sample.

Main exclusion criteria: Patients with metastatic or advanced solid tumors not matching study specifications cannot participate. Those outside the specified age range or part of vulnerable populations are excluded. Patients not meeting safety and tolerability requirements for DS-3939a are also ineligible.

Trial focus: The study is divided into two parts. Part 1 assesses the safety and tolerability of DS-3939a, while Part 2 evaluates both safety and effectiveness at a recommended dose. Participants are closely monitored for side effects and treatment response through regular check-ups, laboratory tests, and imaging studies.

Investigational drugs: DS-3939a is a new medication designed to treat advanced solid tumors. The trial aims to determine if it is safe and how well it works in shrinking or controlling tumors.

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 treatments for advanced solid tumors and lymphomas using two medications: OSE-279, a PD-1 blocking monoclonal antibody, and TEDOPI, a cancer vaccine. The study tests these medications individually and in combination.

Main inclusion criteria: Participants must be at least 18 years old and sign an informed consent form. For Parts B and C, patients need Stage IV non-small cell lung cancer that cannot be treated with surgery or radiation, without certain genetic changes. They must not have received previous treatment for metastatic disease. Participants need at least one measurable tumor, good general health as measured by ECOG performance status, and adequate organ function. For Parts B and C, patients must have the HLA-A2 genetic marker.

Main exclusion criteria: Patients without the HLA-A2 positive phenotype cannot participate in Parts B and C. Those without metastatic non-small cell lung cancer or advanced solid tumors/lymphomas are excluded. Patients outside the specified age range or part of vulnerable populations are ineligible.

Trial focus: The study is divided into three parts. Part A determines the best dose of OSE-279 in patients with advanced solid tumors or lymphomas. Part B evaluates the safety and tolerability of OSE-279 combined with OSE2101 in patients with specific lung cancer. Part C compares the effectiveness of the combination treatment versus OSE-279 alone.

Investigational drugs: OSE-279 blocks PD-1 protein to help the immune system recognize and attack cancer cells. OSE2101 is a cancer vaccine that stimulates the immune system to target and destroy cancer cells. The combination aims to enhance the immune response against tumors.

Study of Pembrolizumab and MK-2870 for Patients with Metastatic Squamous Non-small Cell Lung Cancer

This trial explores the effectiveness of a combination of medications for metastatic squamous non-small cell lung cancer that has spread to other body parts. It investigates pembrolizumab, carboplatin, and taxane (either paclitaxel or nab-paclitaxel), as well as pembrolizumab with or without maintenance treatment using MK-2870.

Main inclusion criteria: Participants must have confirmed Stage IV squamous non-small cell lung cancer. The disease must be measurable according to RECIST 1.1 criteria. Previous treatment side effects must have improved to mild levels or returned to baseline. Participants must have a life expectancy of at least 3 months and a performance status of 0 to 1. Patients with HIV or hepatitis can join if their conditions are well controlled. Participants must not have cancer progression after completing the initial study part.

Main exclusion criteria: Patients who have already received treatment for their lung cancer cannot join. Those with a different lung cancer type than specified are not eligible. People outside the specified age range or part of vulnerable populations cannot participate.

Trial focus: The study compares the overall survival of patients receiving these treatment combinations. Medications are delivered through intravenous infusion with regular monitoring to assess treatment effects. The trial involves an induction phase with pembrolizumab combined with chemotherapy, followed by a maintenance phase with pembrolizumab alone or combined with MK-2870.

Investigational drugs: Pembrolizumab helps the immune system fight cancer cells. Carboplatin and paclitaxel/nab-paclitaxel are chemotherapy drugs that stop cancer cell growth. MK-2870 is an investigational drug studied as maintenance therapy to improve outcomes when used alongside pembrolizumab.

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

This trial explores the use of investigational therapy BNT327 in combination with chemotherapy for non-small cell lung cancer. The chemotherapy drugs include paclitaxel, pembrolizumab, pemetrexed, and carboplatin, given as intravenous infusions.

Main inclusion criteria: Participants must be able to give informed consent and be at least 18 years old. They need confirmed Stage IIIB, IIIC, or Stage IV non-small cell lung cancer without specific genetic mutations. Patients must have at least one measurable tumor, an ECOG performance status of 0 or 1, and a life expectancy of more than 3 months. Adequate organ function is required. Those of childbearing potential must use highly effective birth control and agree not to donate or freeze sperm or eggs during the study.

Main exclusion criteria: Patients with other cancer types, different cancer treatment within the last 4 weeks, severe heart problems, uncontrolled high blood pressure, active infections, pregnancy or breastfeeding status, known allergies to study drugs, history of severe allergic reactions, significant liver or kidney disease, or participation in another trial within 30 days are excluded.

Trial focus: The study is divided into Phase II and Phase III. Phase II assesses BNT327’s safety and tolerability at different dose levels when combined with chemotherapy. Phase III compares the effectiveness of BNT327 with chemotherapy to pembrolizumab with chemotherapy. The study monitors disease progression and overall survival with regular follow-up visits.

Investigational drugs: BNT327 is an investigational medication being tested with chemotherapy to see how well it works and how safe it is. Pembrolizumab is an established medication that helps the immune system recognize and attack cancer cells, used for comparison with BNT327.

Study on the Safety and Effectiveness of BNT327 and Docetaxel for Patients with Advanced Non-Small Cell Lung Cancer After Chemoimmunotherapy

This Phase II trial investigates treatment for stage IV or recurrent non-small cell lung cancer that has progressed after first-line treatment combining chemotherapy with immunotherapy. It tests the combination of investigational drug BNT327 with docetaxel chemotherapy.

Main inclusion criteria: Patients must have confirmed Stage IV or recurrent non-small cell lung cancer that progressed after first-line treatment including immunotherapy and platinum-based chemotherapy. They must have received at least 2 cycles of immunotherapy in their first treatment. Patients need at least one measurable tumor according to RECIST v1.1 criteria, good performance status (ECOG score 0 or 1), adequate organ function, and previous PD-L1 test results available.

Main exclusion criteria: Patients with untreated or unstable brain or spinal cord metastases, unresolved serious side effects from previous treatments, prior treatment with docetaxel or other taxanes, another cancer in the last 3 years (with exceptions), severe heart disease, active lung inflammation or infection, positive HIV or hepatitis status, pregnancy or breastfeeding, severe nerve problems, major surgery within 4 weeks, or current participation in another trial are excluded.

Trial focus: The study assesses the safety and effectiveness of combining BNT327 and docetaxel as second-line treatment. Participants receive treatment in cycles until disease progression or unacceptable side effects. Regular tumor assessments using imaging scans track cancer response. Blood samples monitor BNT327 levels and antibody development. A 90-day safety follow-up occurs after treatment completion.

Investigational drugs: BNT327 is an investigational medication being studied for non-small cell lung cancer that has progressed after first-line chemoimmunotherapy. Docetaxel is a standard chemotherapy medication that interferes with cancer cell division and growth. The combination aims to provide better results than standard treatments for patients whose cancer has progressed after initial therapy.

Study Comparing Subcutaneous and Intravenous Pembrolizumab with Chemotherapy for Patients with Metastatic Non-Small Cell Lung Cancer

This trial studies the treatment of metastatic non-small cell lung cancer that has spread to other body parts. It investigates pembrolizumab, an immunotherapy medication, in combination with chemotherapy drugs including cisplatin, carboplatin, paclitaxel, paclitaxel albumin-bound, and pemetrexed.

Main inclusion criteria: Patients must have confirmed squamous or nonsquamous non-small cell lung cancer diagnosis, adequate organ function, and Stage IV disease. The disease must be measurable according to RECIST V1.1 criteria. Patients must not have received previous treatments for metastatic disease and must have an ECOG performance score of 0 or 1. A tumor tissue sample must be provided. Male patients must agree to use contraception unless confirmed azoospermic. Female patients must not be pregnant or breastfeeding and must use contraception if of childbearing potential.

Main exclusion criteria: Patients with other cancer types besides metastatic non-small cell lung cancer cannot participate. Those outside the specified age range or part of vulnerable populations are excluded.

Trial focus: The study compares two different ways of giving pembrolizumab: as a subcutaneous injection (under the skin) and as an intravenous infusion (through a vein). It examines how the body processes pembrolizumab in these two forms and monitors treatment safety. Participants receive pembrolizumab along with chemotherapy as first-line treatment with regular clinic visits for medication and monitoring.

Investigational drugs: Pembrolizumab helps the immune system fight cancer cells and is being studied in two administration forms. Platinum doublet chemotherapy is a combination of two chemotherapy drugs used alongside pembrolizumab to treat lung cancer.

Study of Pembrolizumab, Carboplatin, and Paclitaxel for Patients with Metastatic Squamous Non-small Cell Lung Cancer

This trial focuses on treating metastatic squamous non-small cell lung cancer that has spread to other body parts. It involves several medications including pembrolizumab (an intravenous infusion), olaparib (an oral tablet), carboplatin and paclitaxel (intravenous infusions), and paclitaxel albumin-bound. A placebo is also used in the study.

Main inclusion criteria: Participants must have confirmed squamous non-small cell lung cancer at Stage IV with measurable disease according to RECIST 1.1 criteria. They must not have received previous treatment for advanced or metastatic disease. A tumor tissue sample approved by a central laboratory must be provided. Patients need a performance status of 0 or 1 on the ECOG scale, a life expectancy of at least 3 months, and adequate organ function. Males must not donate sperm during treatment and for 180 days after. Both males and females of childbearing potential must use birth control during treatment and for 180 days after.

Main exclusion criteria: Patients with different cancer types, those not fully recovered from previous treatments, serious heart problems, active infections requiring treatment, pregnancy or breastfeeding status, past cancer history (unless treated and dormant for a long time), known allergy to study drugs, medications that might interfere with study drugs, certain medical conditions making participation unsafe, or recent participation in another trial are excluded.

Trial focus: The study compares the effectiveness of pembrolizumab combined with olaparib against pembrolizumab combined with a placebo in treating this lung cancer type. It examines effects on time patients live without cancer worsening and overall survival. Participants receive treatments over time with regular check-ups and assessments to monitor treatment response and side effects.

Investigational drugs: Pembrolizumab helps the immune system fight cancer cells, often used in combination with other treatments. Carboplatin and paclitaxel/nab-paclitaxel are chemotherapy drugs that stop cancer cell growth. Olaparib is used as maintenance therapy after initial treatment, working by blocking enzymes cancer cells need for self-repair, which can slow or stop cancer growth.

Study on the Effectiveness of Retifanlimab with Chemotherapy for Patients with Metastatic Non-Small Cell Lung Cancer

This trial studies metastatic non-small cell lung cancer that has spread to other body parts. It investigates the effectiveness of combining new medication Retifanlimab (INCMGA00012) with standard chemotherapy drugs including carboplatin, cisplatin, pemetrexed, and paclitaxel. Some participants receive a placebo instead of Retifanlimab for outcome comparison.

Main inclusion criteria: Participants must be able to understand and sign an informed consent form. They need adequate organ function shown by specific laboratory tests done within 10 days before starting treatment. Patients must be at least 18 years old with confirmed Stage IV non-small cell lung cancer diagnosis. For nonsquamous cancer, specific gene change absence must be confirmed. Patients must not have received prior treatment for advanced or metastatic disease (except certain therapies completed at least 12 months before cancer spread). A tumor tissue sample must be provided. Disease must be measurable according to specific criteria. Participants need an ECOG performance status of 0 or 1, life expectancy of at least 3 months, and willingness to avoid pregnancy or fathering children during the study and for a specified period after.

Main exclusion criteria: Patients with other cancer types not being studied, recent different cancer treatment, certain health conditions that could interfere, pregnancy or breastfeeding status, inability to follow study procedures or attend required visits, allergies to study medications or similar drugs, or participation in another clinical trial at the same time are excluded.

Trial focus: The study aims to see if adding Retifanlimab to chemotherapy can improve overall survival compared to chemotherapy alone. Participants are randomly assigned to receive either the combination or placebo with chemotherapy. The double-blind design means neither participants nor researchers know who receives the actual medication or placebo. Treatments are given through intravenous infusions with participant monitoring over time to assess treatment response and side effects.

Investigational drugs: INCMGA00012 is an investigational medication being studied for its potential to treat lung cancer. It is tested in combination with chemotherapy to see if it can improve outcomes. Platinum-based chemotherapy is a standard treatment for various cancers including lung cancer, using platinum compounds to damage cancer cell DNA and stop their growth and division.

Summary

The 9 ongoing clinical trials for squamous cell carcinoma of lung are distributed across multiple European countries, with the highest concentration in France and Spain, each hosting 7 trials. Other countries with significant trial activity include Poland, Romania, and Belgium. The trials predominantly focus on testing combinations of immunotherapy and chemotherapy approaches for treating metastatic or advanced disease.

Several trials investigate pembrolizumab, an established immunotherapy drug, in various combinations with chemotherapy or experimental agents. Multiple studies explore investigational drugs including OSE2101, OSE-279, BNT327, and DS-3939a, either alone or combined with standard treatments. Some trials specifically target patients with the HLA-A2 genetic marker or those whose cancer has progressed after previous immunotherapy treatment.

The trials span different phases of clinical research, from Phase II (evaluating safety and initial effectiveness) to Phase III (comparing new treatments against standard options). Most studies focus on first-line or second-line treatment settings for patients with metastatic disease. The geographic distribution suggests coordinated European research efforts to develop new treatment options for this challenging form of lung cancer.

Ongoing Clinical Trials on Squamous cell carcinoma of lung

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

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    Germany Italy Poland Spain

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