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Combining BNT327 with chemotherapy for treating lung cancer

A Phase II/III, Multisite, Randomized Master Protocol for a Global Trial of BNT327 in Combination With Chemotherapy and Other Investigational Agents in First-line Non-small Cell Lung Cancer

Phase2; Phase3 Interventional BioNTech SE · NCT06712316

This study is testing if a new treatment called BNT327, when combined with standard chemotherapy, can help people with non-small cell lung cancer feel better and improve their outcomes.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment1260 (estimated)
Ages18 Years and up
SexAll
SponsorBioNTech SE Industry-sponsored
Drugs / interventionschemotherapy, prednisone
Locations206 sites (Anchorage, Alaska and 205 other locations)
Trial IDNCT06712316 on ClinicalTrials.gov

What this trial studies

This Phase 2/3 clinical trial evaluates the safety and effectiveness of BNT327, a bispecific antibody, in combination with standard chemotherapy and other investigational agents for patients with first-line non-small cell lung cancer (NSCLC). The study is divided into two substudies based on histological subtypes, with participants randomized to receive different dose levels of BNT327 plus chemotherapy. An internal review committee will assess the Phase 2 data to determine the appropriate dose for the Phase 3 part of the study, which will also involve an independent data monitoring committee for oversight.

Who should consider this trial

Good fit: Ideal candidates include individuals with Stage IIIB, IIIC, or IV NSCLC who do not have actionable EGFR mutations or ALK rearrangements.

Not a fit: Patients with early-stage lung cancer or those with actionable genetic mutations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced non-small cell lung cancer.

How similar studies have performed: Previous studies involving similar combination therapies have shown promise, but this specific approach with BNT327 is novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Anchorage, Alaska and 205 other locations

+156 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-small Cell Lung CancerFirst-line treatmentCombination with chemotherapyCombination with other investigational agentsBispecific antibodyProgrammed death-ligand 1Vascular endothelial growth factor AImmunotherapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.