A Study to Assess The Safety and Tolerability of Pumitamig‑Based Therapy Administered Before Surgery in Participants With Early‑Stage Non‑Small Cell Lung Cancer (ROSETTA Lung‑220)

Trial status:Will Be Recruiting
Trial ID:
CA266-0020
NCT ID:
NCT07871214
EudraCT ID:
2026-527590-11
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
Bristol-Myers Squibb
Collaborator:
BioNTech SE
Will Be Recruiting

Trial Details

The purpose of this study is to assess the safety, tolerability, and surgical feasibility of preoperative Pumitamig-based therapy and other molecules in resectable, Early-Stage Non-Small Cell Lung Cancer

Medical Condition
Unmapped
Study Drug
Pumitamig
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Carboplatin
Cisplatin
Paclitaxel
Pemetrexed
Phase
Phase 2
Type
Interventional
Estimated Enrolment
80
Estimated Trial Date
Nov 2026 - Mar 2028

Trial Participant Requirements

Age
18+ years
Sex
Female & Male
Healthy Volunteers
No
Inclusion and Exclusion Criteria

    Inclusion Criteria

  • Participants must have newly diagnosed, previously untreated participants with histologically confirmed non-small cell lung cancer (NSCLC) (squamous or non-squamous histology); resectable Stage IIA to IIIB (N2) disease (American Joint Committee on Cancer (AJCC) 9th edition).
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Participants must have an evaluable programmed death-ligand 1 (PD-L1) expression.

    • Exclusion Criteria

  • Participants must not have unresectable disease, N3 nodal involvement, or any evidence of distant metastatic disease (M1) at baseline assessment (suspected or confirmed).
  • Participants must not have active, known autoimmune disease.
  • Participants must not have significant cardiovascular impairment as evidenced by uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias or major thrombotic or embolic events.
  • Participants must not have advanced/clinically significant lung disease (within 6 months prior to randomization) or history of interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids (≥ Grade 2), or who have current or suspected ILD or pneumonitis.
  • Participants must not have significant risk of bleeding or history of major hemorrhagic events (including gastrointestinal (GI) hemorrhage or hemorrhagic stroke).
  • Participants must not have GI or non-GI fistula, GI perforation, or intra-abdominal abscess.
  • Participants must not have prior systemic anticancer therapy, radiotherapy, or investigational therapy for NSCLC or contraindication to curative-intent surgery or study-specified chemotherapy.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Trial Locations

Location
Status
Location
Local Institution - 0069
Long Beach, California, United States, 90806
Status
Location
Local Institution - 0127
Los Angeles, California, United States, 90033
Status
Location
Local Institution - 0136
Tampa, Florida, United States, 33612
Status
Location
Local Institution - 0155
Chicago, Illinois, United States, 60611
Status
Location
Local Institution - 0080
Chestnut Hill, Massachusetts, United States, 02459
Status
Location
Local Institution - 0163
Portland, Oregon, United States, 97239
Status
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