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Recruiting Phase 3 NCT07361497

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)

Phase 3 – large-scale trial before approval
Conditions: Non-small Cell Lung Cancer (NSCLC)

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
Who can participate
Inclusion Criteria * 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 Criteria * 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.
Locations 30
Argentina (1)
Local Institution - 0093
Buenas Aires , Buenos Aires
NOT_YET_RECRUITING
Australia (1)
Local Institution - 0456
Gosford , New South Wales
NOT_YET_RECRUITING
Belgium (1)
Local Institution - 0906
Brasschaat , Antwerpen
NOT_YET_RECRUITING
Brazil (1)
Local Institution - 0615
Teresina , Piauí
NOT_YET_RECRUITING
Bulgaria (1)
Local Institution - 0736
Haskovo
NOT_YET_RECRUITING
Canada (1)
Local Institution - 0337
Ottawa , Ontario
NOT_YET_RECRUITING
Chile (1)
Local Institution - 0910
Antofagasta , AN
NOT_YET_RECRUITING
China (1)
Local Institution - 0754
Beijing , Beijing Municipality
NOT_YET_RECRUITING
France (1)
Local Institution - 0029
Bordeaux , Aquitaine
NOT_YET_RECRUITING
Germany (1)
Local Institution - 0739
Augsburg , Bavaria
NOT_YET_RECRUITING
Greece (1)
Local Institution - 0416
Thessaloniki , Thessaloníki
NOT_YET_RECRUITING
Hong Kong (1)
Local Institution - 0457
Tuenmen , NT
NOT_YET_RECRUITING
Hungary (1)
Local Institution - 0139
Kecskemét , Bács-Kiskun county
NOT_YET_RECRUITING
India (1)
Local Institution - 0840
Eluru , Andhra Pradesh
NOT_YET_RECRUITING
Ireland (1)
Local Institution - 0276
Cork
NOT_YET_RECRUITING
Italy (1)
Local Institution - 0304
Orbassano , Piedmont
NOT_YET_RECRUITING
Japan (1)
Local Institution - 0014
Nagoya , Aichi-ken
NOT_YET_RECRUITING
Mexico (1)
Local Institution - 0772
Saltillo , Coahuila
NOT_YET_RECRUITING
Netherlands (1)
Local Institution - 0243
Nijmegen , Gelderland
NOT_YET_RECRUITING
Poland (1)
Local Institution - 0473
Lublin , Lublin Voivodeship
NOT_YET_RECRUITING
Romania (1)
Local Institution - 0219
Bucharest , Bucharest
NOT_YET_RECRUITING
Singapore (1)
Local Institution - 0650
Singapore , Central Singapore
NOT_YET_RECRUITING
South Korea (1)
Local Institution - 0151
Seongnam , Kyǒnggi-do
NOT_YET_RECRUITING
Spain (1)
Local Institution - 0041
L'Hospitalet Del Llobregat , Barcelona [Barcelona]
NOT_YET_RECRUITING
Sweden (1)
Local Institution - 0033
Gävle , Gävleborgs Län [se-21]
NOT_YET_RECRUITING
Taiwan (1)
Local Institution - 0734
Zhubei , Hsinchu
NOT_YET_RECRUITING
Thailand (1)
Local Institution - 0733
Bangkok
NOT_YET_RECRUITING
Turkey (1)
Local Institution - 0099
Adana
NOT_YET_RECRUITING
United Kingdom (1)
Local Institution - 0239
Manchester , Lancashire
NOT_YET_RECRUITING
United States (1)
Southern Cancer Center Pc
Daphne , Alabama
Michael Meshad, Site 0898
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
16.03.2026
Completion date
31.12.2033
Registry ID
NCT07361497
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.