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Brief Title: Efficacy Comparison of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
Official Title: A Randomized, Phase 2, Double-blind Study to Evaluate the Efficacy of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Metastatic Non-Squamous Non-Small Cell Lung Cancer
Study ID: NCT04581824
Brief Summary: NSCLC comprises of approximately 84 percent (%) of all lung cancers and is often diagnosed at advanced stage due to poor prognosis. Dostarlimab is an immunoglobulin G (IgG)4 kappa humanized monoclonal antibody (mAb) that binds with high affinity to programmed cell death protein 1 (PD 1), resulting in inhibition of binding to programmed death ligand 1 (PD L1) and programmed death ligand 2 (PD L2). This study aims to compare the efficacy and safety PD-1 inhibitors dostarlimab and pembrolizumab, when administered in combination with chemotherapy (pemetrexed, cisplatin and carboplatin), in participants with non-squamous NSCLC without a known sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or receptor tyrosine kinase-1 (ROS-1) mutation, BRAF V600E mutation, or other genomic aberration for which an approved targeted therapy is available. A total of approximately 240 participants will be enrolled in the study for a period of 5 years.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
GSK Investigational Site, Lone Tree, Colorado, United States
GSK Investigational Site, Cincinnati, Ohio, United States
GSK Investigational Site, Fairfax, Virginia, United States
GSK Investigational Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
GSK Investigational Site, Florida, Buenos Aires, Argentina
GSK Investigational Site, La Plata, Buenos Aires, Argentina
GSK Investigational Site, Pergamino, Buenos Aires, Argentina
GSK Investigational Site, Viedma, Río Negro, Argentina
GSK Investigational Site, Rosario, Santa Fe, Argentina
GSK Investigational Site, Ciudad Autónoma de Buenos Aires, , Argentina
GSK Investigational Site, Cordoba, , Argentina
GSK Investigational Site, La Rioja, , Argentina
GSK Investigational Site, San Juan, , Argentina
GSK Investigational Site, Fortaleza, Ceará, Brazil
GSK Investigational Site, Vitória, Espírito Santo, Brazil
GSK Investigational Site, Natal, Rio Grande Do Norte, Brazil
GSK Investigational Site, Barretos, São Paulo, Brazil
GSK Investigational Site, Rio de Janeiro, , Brazil
GSK Investigational Site, São Paulo, , Brazil
GSK Investigational Site, Providencia, Región Metro De Santiago, Chile
GSK Investigational Site, Santiago, Región Metro De Santiago, Chile
GSK Investigational Site, Caen Cedex 9, , France
GSK Investigational Site, Le Mans, , France
GSK Investigational Site, Limoges Cedex, , France
GSK Investigational Site, Pessac cedex, , France
GSK Investigational Site, Saint Herblain cedex, , France
GSK Investigational Site, Valenciennes, , France
GSK Investigational Site, Frankfurt, Hessen, Germany
GSK Investigational Site, Immenhausen, Hessen, Germany
GSK Investigational Site, Oldenburg, Niedersachsen, Germany
GSK Investigational Site, Koeln, Nordrhein-Westfalen, Germany
GSK Investigational Site, Berlin, , Germany
GSK Investigational Site, Napoli, Campania, Italy
GSK Investigational Site, Aviano, Friuli-Venezia-Giulia, Italy
GSK Investigational Site, Roma, Lazio, Italy
GSK Investigational Site, Brescia, Lombardia, Italy
GSK Investigational Site, Milano, Lombardia, Italy
GSK Investigational Site, Milano, Lombardia, Italy
GSK Investigational Site, Busan, , Korea, Republic of
GSK Investigational Site, Cheongju-si, Chungcheongbuk-do, , Korea, Republic of
GSK Investigational Site, Seoul, , Korea, Republic of
GSK Investigational Site, Seoul, , Korea, Republic of
GSK Investigational Site, Seoul, , Korea, Republic of
GSK Investigational Site, Bydgoszcz, , Poland
GSK Investigational Site, Lodz, , Poland
GSK Investigational Site, Lublin, , Poland
GSK Investigational Site, Olsztyn, , Poland
GSK Investigational Site, Poznan, , Poland
GSK Investigational Site, Bucuresti, , Romania
GSK Investigational Site, Craiova, , Romania
GSK Investigational Site, Floresti, , Romania
GSK Investigational Site, Barcelona, , Spain
GSK Investigational Site, Jaén, , Spain
GSK Investigational Site, Lugo, , Spain
GSK Investigational Site, Málaga, , Spain
GSK Investigational Site, Sevilla, , Spain
GSK Investigational Site, Changhua, , Taiwan
GSK Investigational Site, Taipei, , Taiwan
Name: GSK Clinical Trials
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR