A randomized phase 2/3 trial in non‑small cell lung cancer of BNT327 in combination with chemotherapy
Trial Details
The goal of this trial is to learn about the safety of a trial drug called BNT327 and whether it works compared to existing treatment for people with advanced non-small cell lung cancer who have not had treatment yet. BNT327 is designed to block two mechanisms the cancer uses to evade the immune system’s natural defense thereby aiming to enhance anti-tumor responses. More than 1000 patients have been treated with BNT327 in clinical trials to date. Multiple clinical trials are currently ongoing evaluating BNT327 either on its own or in combination with other treatments.
The trial will be conducted in two portions:
- The earlier portion of the trial will evaluate safety and efficacy of different doses of BNT327 in combination with chemotherapy and alone and how well it works compared to existing treatment.
- The later portion of the trial will evaluate the safety and effectiveness of BNT327 in combination with chemotherapy and alone, compared to pembrolizumab (a lung cancer treatment that’s already approved in many countries).
Trial Participant Requirements
This Phase 2/3 clinical trial starts by evaluating the best dose of BNT327 by looking for early signs that the treatment helps while checking how well it’s tolerated. If results are encouraging, it moves on to include more people to confirm how well it works compared to the standard of care (Phase 3). Regardless of the enrolled phase, the process remains the same and involves the following periods:
- Screening period: This lasts up to 28 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 join the earliest part of the trial (Phase 2), there will be two possible dose levels of BNT327 in combination with chemotherapy. You will be randomly assigned to one of these dose groups.
If you join the later part of the trial (Phase 3), you will receive either BNT327 or pembrolizumab in combination with chemotherapy during the initial treatment period. After that, you may continue with just BNT327 or pembrolizumab during the longer maintenance treatment period.
You may receive treatment for up to two years as part of this clinical 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 advanced non-small cell lung cancer that has not been treated yet.
- You have at least one tumor that can be measured by doctors.
Participants must not
- You have already received treatment for your lung cancer.
- You have other health conditions that could make it unsafe to take part (the trial team will review this with you)..
- You are pregnant or breastfeeding.
- Have systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 9th edition.
- 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 Performance Status of 0 or 1.
- Adequate organ function.
- Have histologically or cytologically confirmed NSCLC with small-cell lung cancer histologic or neuroendocrine component.
- Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:
- Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neo-adjuvant/adjuvant or locally advanced/metastatic setting.
- Participants who received prior treatment with anti-VEGF monoclonal antibody, or 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 uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.
- Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing fistula/perforation.
- Participants with significant risk of hemorrhage (per investigator clinical judgment).
- Have superior vena cava syndrome or symptoms of spinal cord compression.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
About Non-small cell lung cancer ("NSCLC")
Non-small cell lung cancer (“NSCLC”) is the most common type of lung cancer, making up about 80% to 85% of all cases1. Many people are not diagnosed until the cancer has already spread, which makes it more difficult to treat.
Chemotherapies and/or immunotherapies have been the primary ways of treatment but recurrence frequently occurs. Researchers are now evaluating new ways to treat advanced non-small cell lung cancer. Non-small cell lung cancer clinical trials like this one are part of that effort to improve care and outcomes.
1Reference: Ozkaya et al., 2012; Petrella et al., 2023; Chen et al., 2023; Goldstraw et al., 2007; Cetin et al., 2011; Schiller et al., 2002.