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Clinical Trials List

Protocol NumberCA2660002

Active

2026-03-15 - 2032-10-25

Phase III

Recruiting5

ROSETTA Lung-202: A randomized, double-blind, Phase 3 trial comparing pumitamig monotherapy with pembrolizumab as first-line treatment for participants with locally advanced or metastatic non-small cell lung cancer and PD-L1 expression ≥ 50%.

Trial Applicant

BRISTOL-MYERS SQUIBB (TAIWAN) LTD.
Sponsor

Bristol-Myers Squibb Taiwan Co., Ltd.
Trial scale

Multi-Regional Multi-Center
Update

2026/10/12

Investigators and Locations

Principal Investigator 黃國棟無

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張晟瑜無

Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 魏裕峰無

E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Ta Yang

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Comparison of Pumitamig monotherapy versus Pembrolizumab as first-line treatment for participants with locally advanced or metastatic non-small cell lung cancer and PD-L1 expression ≥ 50%.

Objectives

• Progression-free survival (PFS) of pumitamig versus pembrolizumab in participants with advanced NSCLC and PD-L1 expression ≥50% (assessed by Blinded Independent Central Review [BICR]). • Overall survival (OS) of pumitamig versus pembrolizumab in participants with advanced NSCLC and PD-L1 expression ≥50%.

Test Drug

BMS-986545

Active Ingredient

Pumitamig/PM8002/BNT327

Dosage Form

Infusion fluid

Dosage

20 mg/mL or 50 mg/mL

Endpoints

• PFS assessed by BICR (based on Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1)
• OS

Inclution Criteria

Key inclusion criteria:
• Male and female patients aged ≥ 18 years.
• Histologically or cytologically confirmed Stage IIIB/IIIC or Stage IV NSCLC (squamous and non-squamous) according to the 9th edition of the UICC/AJCC staging system.
• PD-L1 expression ≥ 50%, determined by a local PD-L1 immunohistochemistry (IHC) assay (VENTANA PD-L1 [SP263] assay, Agilent PD-L1 IHC 22C3 pharmDx, or Agilent PD-L1 IHC 28-8 pharmDx) pre-approved by the sponsor, or by central testing.
• Submission of tumor tissue is required (fresh or archival specimen; archival specimens must have been collected within 6 months prior to signing the informed consent form).
• Measurable disease as defined by RECIST version 1.1, with at least one measurable extracranial lesion.
• No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC. Note: Prior chemoradiotherapy for locally advanced disease, or prior chemotherapy as neoadjuvant or adjuvant therapy, is permitted provided disease progression occurred at least 6 months after the last dose. Prior immunotherapy as neoadjuvant and/or adjuvant therapy, or as part of concurrent chemoradiotherapy (CCRT), is permitted provided disease progression occurred at least 12 months after the last dose.
• ECOG performance status score of 0 or 1.

Exclusion Criteria

Key exclusion criteria:
• Tumors exhibiting mixed histology, including small-cell and sarcomatoid components.
• Any documented actionable genomic alteration (AGA) for which an approved first-line therapy exists; testing should be performed as part of clinical practice and in accordance with local health authority regulations.
• Symptomatic and untreated central nervous system (CNS) metastases, leptomeningeal metastases (carcinomatous meningitis), or spinal cord compression.
• Significant cardiovascular dysfunction, manifested as uncontrolled hypertension (despite optimal medical therapy), congestive heart failure, active coronary artery disease, ventricular arrhythmias, or major thrombotic or embolic events.
• Active autoimmune disease. Note: Participants with type 1 diabetes, residual hypothyroidism requiring only hormone replacement therapy due to autoimmune thyroiditis, or skin conditions not requiring systemic therapy (e.g., vitiligo, psoriasis, or alopecia) are eligible for inclusion.
• Advanced/clinically significant pulmonary disease (within 6 months prior to randomization), or a history of interstitial lung disease (ILD) or pneumonitis (≥ Grade 2) requiring systemic steroid therapy, or current/suspected ILD or pneumonitis.
• Significant risk of pulmonary hemorrhage: radiographic evidence of tumor invasion into major blood vessels, major airways, or vital organs; significant cavitation; or clinically significant hemoptysis (≥ 1 teaspoon/5 mL) within 4 weeks prior to randomization. • Significant risk of bleeding or a history of major bleeding events (including gastrointestinal [GI] bleeding or hemorrhagic stroke) within 6 months prior to randomization
• GI or non-GI fistula, GI perforation, or intra-abdominal abscess (within 6 months prior to randomization)
• Severe unhealed wound, skin ulcer, or unhealed fracture (within 4 weeks prior to randomization)
• Urine protein ≥ 2+ by dipstick and 24-hour urine protein ≥ 1 g/24 hours
• Prior organ allograft or allogeneic bone marrow transplantation

The Estimated Number of Participants

Taiwan

30 participants
Global

750 participants