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RecruitingLast updated: 19 May 2026

BNT327-06: This study is recruiting people with non-small cell lung cancer to evaluate a drug called BNT327 in combination with chemotherapy and other treatmentsA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Lung Cancers Lung cancer

Age

People18+

Trial acronym

BNT327-06

Clinical summary

Summary

This study is testing a new treatment for people who have been newly diagnosed with a type of lung cancer called non-small cell lung cancer (NSCLC).

The study has two parts (called Substudy A and Substudy B). People will be placed into one of these substudies based on the specific type of their lung cancer, because different types are usually treated with different chemotherapy medicines.

Each substudy has two stages.

Phase 2 stage
This part looks at finding the best dose of pumitamig (also known as BNT327) and understanding how well the treatment works. Participants will be randomly assigned (by chance) to recieive one of two dose levels of pumitamig, together with standard chemotherapy.

Phase 3 stage
This part compares how well pumitamig works compared to other standard treatments in a larger gorup of people. Participants will be randomly assigned to receive either the dose level of pumitamig identified in the previous stage plus chemotherapy, or pembrolizumab immunotherapy with standard chemotherapy.

Each participant may be in the study for up to about 5 years and 4 months (64 months).

 

Conditions

This trial is treating people with non-small cell lung cancer

Eligibility

Inclusion

  • 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.

Exclusion

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

BioNTech SE

Scientific Title

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

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