Pumitamig compared with durvalumab after chemoradiation for non-small cell lung cancer
Compares pumitamig with durvalumab in adults whose lung cancer cannot be removed surgically.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)
Key facts
- Where
- Beijing, Changsha, Chengdu, Chongqing, Fuzhou, Guangzhou, Hangzhou, Jinan, Jingzhou, Linhai, Nanchang, Shanghai, Shanghai Shi, Shantou, Shenyang, Shenzhen, Suzhou, Taiyuan, Wuhan, Xi'an, Xi’an, and Zhengzhou, ChinaSee the 26 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
Source: NCT07361497, who can take part
Where in China
- Beijing Cancer HospitalBeijing, ChinaTaking people
- ChangshaChangsha, ChinaNot yet recruiting
- Sichuan Cancer HospitalChengdu, ChinaTaking people
- West China Hospital，Sichuan UniversityChengdu, ChinaTaking people
- Chongqing University Cancer HospitalChongqing, ChinaTaking people
- Fujian Cancer HospitalFuzhou, ChinaTaking people
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaTaking people
- The second Affiliated Hospital of College of Medicine, Zhejiang UniversityHangzhou, ChinaTaking people
- Zhejiang Cancer HospitalHangzhou, ChinaTaking people
- Qilu Hospital of Shandong UniversityJinan, ChinaTaking people
- Shandong Cancer HospitalJinan, ChinaTaking people
- Jingzhou First People's HospitalJingzhou, ChinaTaking people
- Taizhou Hospital of Zhejiang ProvinceLinhai, ChinaTaking people
- The Second Affiliated Hospital of Nanchang UniversityNanchang, ChinaTaking people
- ShanghaiShanghai, ChinaNot yet recruiting
- Shanghai ShiShanghai Shi, ChinaNot yet recruiting
- Cancer Hospital of Shantou University Medical CollegeShantou, ChinaTaking people
- ShenyangShenyang, ChinaNot yet recruiting
- Peking University Shenzhen HospitalShenzhen, ChinaTaking people
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
- Shanxi Cancer hospitalTaiyuan, ChinaTaking people
- The Central Hospital of WuhanWuhan, ChinaTaking people
- WuhanWuhan, ChinaNo longer taking part
- The Second Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, ChinaTaking people
- The First Affiliated Hospital of Xi'an Jiaotong UniversityXi’an, ChinaTaking people
- Henan Cancer HospitalZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT07361497EU 2025-523576-23-00
- Record updated
- 5 November 2026
- Original description
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)Read full original descriptionShow less
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 to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
Inclusion: 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.
Exclusion: 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; Participants must not have an active autoimmune disease; Participants with non-squamous histology must not have documented Epidermal Growth Factor Receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements; Other protocol-defined Inclusion/Exclusion criteria apply.