A Randomized, Open Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel To Dostarlimab + Docetaxel To Docetaxel Alone In Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed On Prior Anti-PD-(L)1 Therapy And Chemotherapy (COSTAR Lung)

Who is this study for? Patients with advanced nonsmall cell lung cancer who have progressed on prior anti-PD-(L)1 therapy and chemotherapy
Status: Active_not_recruiting
Location: See all (167) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a multi-center, parallel group treatment, Phase 2/3 open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced non-small cell Lung Cancer (NSCLC) who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participant has histologically or cytologically proven advanced or metastatic NSCLC and only squamous or non-squamous cell carcinoma.

• Participant has received no more than 2 prior lines of therapy for advanced or metastatic disease, which must only include a platinum based (e.g., cisplatin, carboplatin) doublet chemotherapy regimen and an anti-PD-1 or an anti-PD-(L)1 antibody.

• Participant has measurable disease.

• Participant has documented radiographic disease progression on prior platinum based chemotherapy and on or after prior anti-PD-(L)1 therapy.

• Participant agrees to submit an archival formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen that was collected on or after diagnosis of metastatic disease. If archival tissue is not available, the participant must undergo biopsy prior to study entry.

• Participant has an ECOG performance status score of 0 or 1.

• Participant has a life expectancy of at least 3 months.

• Participant has adequate Baseline organ function.

• Participant has recovered from any prior treatment related toxicities.

• Participant agrees to use contraception.

Locations
United States
California
GSK Investigational Site
Fountain Valley
GSK Investigational Site
Walnut Creek
Connecticut
GSK Investigational Site
Norwich
Washington, D.c.
GSK Investigational Site
Washington
Hawaii
GSK Investigational Site
Honolulu
Iowa
GSK Investigational Site
Iowa City
Kentucky
GSK Investigational Site
Edgewood
Nevada
GSK Investigational Site
Las Vegas
New York
GSK Investigational Site
Mineola
GSK Investigational Site
New York
GSK Investigational Site
White Plains
Pennsylvania
GSK Investigational Site
Pittsburgh
GSK Investigational Site
Pittsburgh
South Dakota
GSK Investigational Site
Sioux Falls
Texas
GSK Investigational Site
Houston
Virginia
GSK Investigational Site
Fredericksburg
Washington
GSK Investigational Site
Tacoma
Other Locations
Argentina
GSK Investigational Site
Buenos Aires
GSK Investigational Site
Cipoletti Rio Negro
GSK Investigational Site
Ciudad Autonoma De Buenos Aire
GSK Investigational Site
Florida
GSK Investigational Site
La Rioja
GSK Investigational Site
Pergamino
GSK Investigational Site
Rosario
GSK Investigational Site
Viedma
Australia
GSK Investigational Site
Ashford
GSK Investigational Site
Ballarat
GSK Investigational Site
Hobart
GSK Investigational Site
Melbourne
GSK Investigational Site
Mount Waverley
GSK Investigational Site
South Brisbane
Belgium
GSK Investigational Site
Aalst
GSK Investigational Site
Hasselt
GSK Investigational Site
Kortrijk
Brazil
GSK Investigational Site
Blumenau
GSK Investigational Site
Fortaleza
GSK Investigational Site
Porto Alegre
GSK Investigational Site
Rio De Janeiro
GSK Investigational Site
Rio De Janeiro
GSK Investigational Site
Salvador
GSK Investigational Site
Sao Paulo
Canada
GSK Investigational Site
Greenfield Park
GSK Investigational Site
Kingston
GSK Investigational Site
Montreal
GSK Investigational Site
Oshawa
GSK Investigational Site
Sudbury
Finland
GSK Investigational Site
Helsinki
GSK Investigational Site
Kuopio
France
GSK Investigational Site
Creteil Cedex
GSK Investigational Site
Grenoble Cedex 9
GSK Investigational Site
Marseille
GSK Investigational Site
Nice Cedex 2
GSK Investigational Site
Quimper Cedex
GSK Investigational Site
Rennes
GSK Investigational Site
Tours Cedex 9
Germany
GSK Investigational Site
Augsburg
GSK Investigational Site
Bad Berka
GSK Investigational Site
Berlin
GSK Investigational Site
Bonn
GSK Investigational Site
Dresden
GSK Investigational Site
Essen
GSK Investigational Site
Frankfurt
GSK Investigational Site
Frankfurt
GSK Investigational Site
Halle
GSK Investigational Site
Heidelberg
GSK Investigational Site
Karlsruhe
GSK Investigational Site
Koeln
GSK Investigational Site
Muenchen
GSK Investigational Site
Munchen
GSK Investigational Site
Oldenburg
Greece
GSK Investigational Site
Athens
GSK Investigational Site
Athens
GSK Investigational Site
Athens
GSK Investigational Site
Athens
GSK Investigational Site
Larissa
GSK Investigational Site
Pylaia Thessaloniki
GSK Investigational Site
Rio Patras
GSK Investigational Site
Thessaloniki
GSK Investigational Site
Thessaloniki
Italy
GSK Investigational Site
Ancona
GSK Investigational Site
Avellino
GSK Investigational Site
Firenze
GSK Investigational Site
Milano
GSK Investigational Site
Milano
GSK Investigational Site
Monza
GSK Investigational Site
Napoli
GSK Investigational Site
Orbassano To
GSK Investigational Site
Perugia
GSK Investigational Site
Siena
Japan
GSK Investigational Site
Kyoto
GSK Investigational Site
Miyagi
GSK Investigational Site
Osaka
GSK Investigational Site
Yamaguchi
Mexico
GSK Investigational Site
Guadalajara
GSK Investigational Site
Mexico City
GSK Investigational Site
Mexico City
GSK Investigational Site
Mexico City
GSK Investigational Site
Mexico City
GSK Investigational Site
Monterrey
GSK Investigational Site
Puebla Puebla
Netherlands
GSK Investigational Site
Amersfoort
GSK Investigational Site
Enschede
GSK Investigational Site
Groningen
GSK Investigational Site
Harderwijk
GSK Investigational Site
Nijmegen
GSK Investigational Site
Utrecht
GSK Investigational Site
Zwolle
Poland
GSK Investigational Site
Bydgoszcz
GSK Investigational Site
Gdynia
GSK Investigational Site
Lodz
GSK Investigational Site
Olsztyn
GSK Investigational Site
Pila
GSK Investigational Site
Poznan
Republic of Korea
GSK Investigational Site
Cheongju Chungcheongbuk-do
GSK Investigational Site
Daegu
GSK Investigational Site
Gyeonggi-do
GSK Investigational Site
Pusan
GSK Investigational Site
Seongnam-si Gyeonggi-do
GSK Investigational Site
Seoul
GSK Investigational Site
Seoul
GSK Investigational Site
Seoul
GSK Investigational Site
Seoul
GSK Investigational Site
Suwon Kyunggi-do
Romania
GSK Investigational Site
Bucuresti
GSK Investigational Site
Craiova
GSK Investigational Site
Craiova Dolj
GSK Investigational Site
Otopeni
GSK Investigational Site
Timisoara
Russian Federation
GSK Investigational Site
Chelyabinsk
GSK Investigational Site
Moscow Region
GSK Investigational Site
Pushkin
GSK Investigational Site
Saint-petersburg
Spain
GSK Investigational Site
A Coruna
GSK Investigational Site
Badalona
GSK Investigational Site
Barcelona
GSK Investigational Site
Barcelona
GSK Investigational Site
Burgos
GSK Investigational Site
Cordoba
GSK Investigational Site
Las Palmas De Gran Canar
GSK Investigational Site
Madrid
GSK Investigational Site
Madrid
GSK Investigational Site
Madrid
GSK Investigational Site
Madrid
GSK Investigational Site
Madrid
GSK Investigational Site
Madrid
GSK Investigational Site
Malaga
GSK Investigational Site
Valencia
Sweden
GSK Investigational Site
Gavle
GSK Investigational Site
Stockholm
GSK Investigational Site
Uppsala
Taiwan
GSK Investigational Site
Hsinchu
GSK Investigational Site
Taichung
GSK Investigational Site
Taipei
GSK Investigational Site
Taipei
Thailand
GSK Investigational Site
Bangkok
GSK Investigational Site
Dusit
GSK Investigational Site
Kho Hong Hat Yai
GSK Investigational Site
Khon Kaen
GSK Investigational Site
Pathumthani
Turkey
GSK Investigational Site
Adana
GSK Investigational Site
Antalya
GSK Investigational Site
Izmir
United Kingdom
GSK Investigational Site
Cardiff
GSK Investigational Site
Edinburgh
GSK Investigational Site
London
GSK Investigational Site
London
GSK Investigational Site
Manchester
Time Frame
Start Date: 2020-12-08
Completion Date: 2025-10-31
Participants
Target number of participants: 758
Treatments
Experimental: Participants receiving cobolimab+ dostarlimab+ docetaxel
Experimental: Participants receiving dostarlimab+ docetaxel
Active_comparator: Participants receiving docetaxel
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov