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]