NCT06712316 Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer
| NCT ID | NCT06712316 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | BioNTech SE |
| Condition | Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,260 participants |
| Start Date | 2025-01-07 |
| Primary Completion | 2029-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 1,260 participants in total. It began in 2025-01-07 with a primary completion date of 2029-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC). This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.
Eligibility Criteria
Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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.
Contact & Investigator
BioNTech Responsible Person
STUDY DIRECTOR
BioNTech SE
Frequently Asked Questions
Who can join the NCT06712316 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06712316 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06712316 currently recruiting?
Yes, NCT06712316 is actively recruiting participants. Contact the research team at patients@biontech.de for enrollment information.
Where is the NCT06712316 trial being conducted?
This trial is being conducted at Birmingham, United States, Anchorage, United States, Concord, United States, La Jolla, United States and 11 additional locations.
Who is sponsoring the NCT06712316 clinical trial?
NCT06712316 is sponsored by BioNTech SE. The principal investigator is BioNTech Responsible Person at BioNTech SE. The trial plans to enroll 1,260 participants.
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