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Spots Global Cancer Trial Database for Efficacy Comparison of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: GSK Clinical Trials

Affiliation: GlaxoSmithKline

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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