Clinical trial locations
- Austria
- Belgium
- Bulgaria
- Czechia
- France
- Germany
- Greece
- Hungary
- Ireland
- Italy
- Netherlands
- Poland
- Portugal
- Romania
- Spain
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.
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.