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ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 Study of Pumitamig Monotherapy Compared to Durvalumab in Participants with Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy

A Study of Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants with Unresectable Stage III NSCLC (CA266-0001)

Lee Chung-Wei

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

mg-jp-clinical_trial@bms.com

Lee Chung-Wei

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

+81-120-093-507

MG-JP-RCO-JRCT@bms.com

Recruiting

May. 15, 2026

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- Participants must have a histologically- or cytologically-confirmed diagnoses of non-small cell lung cancer (NSCLC) with unresectable Stage III disease.
- Participants must have received at least 2 cycles of platinum-based concurrent chemoradiotherapy (a total dose of radiation of at least 54 Gy).
- Participants must have no progressive disease (PD) following treatment with concurrent chemoradiotherapy (CCRT).
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.

- Participants with non-squamous histology must not have documented Epidermal Growth Factor Receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements.
- Participants must not have an active autoimmune disease.
- Participants must not have significant cardiovascular impairment such as uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, major thrombotic or embolic events or major hemorrhagic events within 6 months prior to randomization, or significant risk of pulmonary hemorrhage.
- 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 current or suspected ILD or pneumonitis.
- Participants must not have any prior anticancer therapy (outside of CCRT) for locally advanced Stage III disease.
- Other protocol-defined Inclusion/Exclusion criteria apply.

Both

Non-small Cell Lung Cancer (NSCLC)

Drug: Pumitamig
Drug: Durvalumab

Progression-free survival (PFS) by blinded independent central review (BICR) (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)

- Overall survival (OS)
- PFS by investigator (per RECIST v1.1)
- OR by BICR (per RECIST v1.1)
- DCR by BICR (per RECIST v1.1)
- DOR by BICR (per RECIST v1.1)
- TTR by BICR (per RECIST v1.1)

+81-798-45-6094

Mar. 18, 2026

Yes

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

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