A randomized phase 3 trial in first‑line extensive‑stage small‑cell lung cancer of BNT327 in combination with chemotherapy
Trial Details
Advancements in small-cell lung cancer clinical trials are leading to new options for patients with extensive-stage small-cell lung cancer (“ES-SCLC”). This trial is evaluating a new trial drug called BNT327 to learn whether it is safe and helpful for people with this fast-growing cancer. BNT327 could help patients who don't have many choices today. More than 1000 patients have been treated with BNT327 in clinical trials to date.
In this trial, researchers are evaluating the safety of BNT327 and whether it works when combined with standard chemotherapy drugs (etoposide and carboplatin). They will compare it to another treatment called atezolizumab when also combined with the same chemotherapy drugs. Atezolizumab is an immunotherapy already approved in multiple countries. The goal is to determine which one works better for patients who have not been treated before for extensivestage small-cell lung cancer.
Trial Participant Requirements
This Phase 3 clinical trial includes:
- Screening period: This lasts up to 21 days and is when doctors check if participants can join the trial.
- Treatment period: This lasts up to four cycles of 21 days each, where participants receive the treatment on the first day of each cycle.
- Maintenance period: This can last up to 2 years and is when participants continue to receive treatment to keep the cancer from coming back.
- Follow-up period: This includes safety check-ups at 30 days and 90 days after the last treatment.
- Long-term follow-up: Where participants are contacted every 3 months to see if they are well and to see if they have started a new anticancer treatment.
If you qualify, you’ll be randomly placed into one of two treatment groups. You will receive either BNT327 or atezolizumab in combination with chemotherapy.
The treatment is delivered as an infusion. The first part of treatment (treatment period) lasts about 3 months. After that, you may continue treatment for up to 2 years. During the 2 years you will continue treatment cycles with either BNT327 or atezolizumab only. This period may end before the two years if your disease changes course, you have unwanted side effects, or you choose to leave the trial. Two safety check-ups will be performed 30 days and 90 days after the last treatment.
By joining clinical trials like this one, you can help researchers discover new treatments and further understanding of potential treatment options for people with lung cancer. There is no cost to you for the trial medicine or any tests or procedures that are part of the trial. Some of the trial costs may be covered by your medical insurance (if applicable). The medical staff carrying out the clinical trial will discuss this topic with you during the pre-screening process.
Key Inclusion and Exclusion criteria
This trial is looking for participants who may qualify, based on their age, diagnosis, and overall health. For more information, please contact [email protected].
Participants must
- You are 18 years or older.
- You have been diagnosed with extensive-stage small-cell lung cancer.
- Your small-cell lung cancer is advanced or it has been at least 6 months since your last treatment for limited-stage disease.
- You have at least one tumor that can be seen on a scan.
Participants must not
- You are pregnant or breastfeeding.
- You have already started treatment for your small-cell lung cancer within the past 6 months.
- You have a serious heart condition or uncontrolled illness that could affect your safety during the trial.
- You have active infections (like tuberculosis or hepatitis) or serious immune system conditions.
- Have histologically or cytologically confirmed ES-SCLC (using the AJCC [American Joint Committee on Cancer] tumor node metastasis staging system combined with Veterans Administration Lung Study Group [VALG]'s two stage classification scheme). For AJCC tumor node metastasis staging system: AJCC 8th edition stage IV (T any, N any, M1a/b/c), or T3\~4 for multiple lung nodules or tumor/nodule volume that cannot be encompassed in a tolerable radiotherapy plan.
- Have not had prior systemic therapy for ES-SCLC. However, participants with prior chemoradiotherapy for limited-stage-SCLC must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible.
- Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematologic and organ function as defined in the protocol.
- Have histologically or cytologically confirmed SCLC with combined histologies.
- Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:
- Within 2 weeks: small molecule agents with half-life of \<7 days; radiation outside the thoracic cavity including whole brain radiation. Of note, other local radiation for brain lesions (not whole brain) is allowed; local radiation for bone lesions is allowed. Palliative bone radiation or brain stereotactic radiosurgery would not require a washout period, but participants should recover from radiotherapy-related toxicity.
- Within 4 weeks: radiation involving the thoracic cavity; small molecule targeted agents with half-life of ≥7 days; monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies.
- Have received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or programmed death (ligand)-1 (PD[L]-1)/VEGF bispecific antibody.
- Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.
- Have the following central nervous system metastases:
- Participants with untreated brain metastases that are symptomatic or large (e.g., greater than 2 cm).
- Participants with treated central nervous system (CNS) metastases who are not neurologically stable or on steroids (at a dosage greater than 10 mg/Day of prednisone or an equivalent dose of other corticosteroid) within 7 days before initiating study treatment of this study.
- Participants with known leptomeningeal metastases.
- Have uncontrolled hypertension or poorly controlled diabetes prior to study treatment.
- Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess for which an interval of 6 months must pass before study entry. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation.
- Have a significant risk of hemorrhage (per investigator clinical judgment) as defined in the protocol.
- Have superior vena cava syndrome or symptoms of spinal cord compression that requires urgent medical intervention.
NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
About small-cell lung cancer ("SCLC")
Small cell lung cancer (“SCLC”) is a type of lung cancer that grows very fast. Because it grows quickly, it's important to find new ways to treat it.
Chemotherapies and/or immunotherapies have been the primary ways of treatment but recurrence frequently occurs. Researchers are now evaluating new ways to treat advanced small-cell lung cancer. Small-cell lung cancer clinical trials like this one are part of that effort to improve care and outcomes.