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
- Bunkyo Ku, Fukuoka, Hamamatsu, Hidaka, Hirakata, Kobe, Nagoya, Nishinomiya, Okayama, Sagamihara, Sakai, Sendai, and Yokohama, JapanSee the 14 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with non-small cell lung cancer (NSCLC) that cannot be removed by surgery (stage III). Their cancer must not have grown after chemotherapy given together with radiation.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Non-small cell lung cancer, stage III, cannot be removed by surgery, confirmed by tissue or cell tests
- Earlier treatment
- Must have had at least 2 cycles of platinum-based chemotherapy given together with radiation (total radiation dose at least 54 Gy), with no cancer growth afterwards. Must not have had other cancer treatment for stage III disease.
- Biomarker or test result
- If the cancer is non-squamous, it must not have documented EGFR or ALK gene rearrangements.
Main reasons for not taking part
- Active autoimmune disease
- Serious heart or blood vessel problems, such as uncontrolled high blood pressure or heart failure
- Serious lung disease, or past or current interstitial lung disease or pneumonitis
- Other cancer treatment for stage III disease apart from chemoradiation
Read by machine on 13 November 2026.
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 Japan
- Tokyo Metropolitan Komagome HospitalBunkyo Ku, JapanContact: kanako shinada, Site 0018Taking people
- National Hospital Organization Kyushu Cancer CenterFukuoka, JapanContact: Masafumi Yamaguchi, Site 0009Taking people
- Hamamatsu University HospitalHamamatsu, JapanContact: Naoki Inui, Site 0158Taking people
- Saitama Medical University International Medical CenterHidaka, JapanContact: Hiroshi Kagamu, Site 0149Taking people
- Kansai Medical University HospitalHirakata, JapanContact: Takayasu Kurata, Site 0016Taking people
- Kobe University HospitalKobe, JapanContact: Motoko Tachihara, Site 0701Taking people
- Aichi Cancer Center HospitalNagoya, JapanContact: Junichi Shimizu, Site 0014Taking people
- Hyogo Medical University HospitalNishinomiya, JapanContact: Takashi Kijima, Site 0154Taking people
- Okayama University HospitalOkayama, JapanContact: Eiki Ichihara, Site 0907Taking people
- Kitasato University HospitalSagamihara, JapanContact: Katsuhiko Naoki, Site 0157Taking people
- Kindai University HospitalSakai, JapanContact: Hidetoshi Hayashi, Site 0002Taking people
- Sendai Kousei HospitalSendai, JapanContact: Shunichi Sugawara, Site 0001Taking people
- Tohoku University HospitalSendai, JapanContact: Eisaku Miyauchi, Site 0759Taking people
- Kanagawa Cancer CenterYokohama, JapanContact: Shuji Murakami, Site 0008Taking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.