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RecruitingPhase 2 / Phase 3NCT06712316
Official study title

Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPumitamig and Pembrolizumab

Plus 3 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 15, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 2 / Phase 3

Interventional

Where is it offered?365 U.S. locations

Locations may change over time.

Who runs it?BioNTech SE

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2 / Phase 3
Sponsor
BioNTech SE
Interventions being studied
Drug: Pumitamig; Drug: Pembrolizumab; Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Immunotherapy→Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Key
  • 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 as defined in the protocol. Key
Reasons someone may not be able to joinExclusion criteria
  • Have histologically or cytologically confirmed NSCLC with small-cell lung cancer or neuroendocrine histologic 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 neoadjuvant/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).
  • Participants have superior vena cava syndrome or symptoms of spinal cord compression. NOTE: Other protocol defined Inclusion/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Birmingham Hematology and Oncology Associates LLC d/b/a Alabama OncologyBirmingham, Alabama
  • Alaska Oncology and Hematology, LLCAnchorage, Alaska
  • John Muir Clinical Research CenterConcord, California
  • University Of California - San Diego Moores Cancer CenterLa Jolla, California
  • Vail HealthVail, Colorado
  • MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)Washington D.C., District of Columbia
  • MEDSTAR Washington Hospital Center (MedStar Health Research Institute)Washington D.C., District of Columbia
  • Clermont Oncology CenterClermont, Florida
  • SSAK Partners, LLC.Coral Springs, Florida
  • Baptist Medical Center JacksonvilleJacksonville, Florida
  • Mid Florida Cancer CentersOrange City, Florida
  • Cleveland Clinic Florida - Martin North HospitalStuart, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 15, 2026. Always confirm current availability with the study team.

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