Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-Small Cell Lung Cancer Who Have Progressed on Prior Anti- Programmed Death-ligand 1 (PD-[L]1) Therapy and Chemotherapy

Lung Cancer, Non-Small Cell Clinical Trial

— COSTAR Lung  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04655976
• Other study ID #: 213410
• Secondary ID: 2020-003433-37
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: December 8, 2020
• Est. completion date: October 31, 2025

Study information

• Verified date: February 2024
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 758
• Est. completion date: October 31, 2025
• Est. primary completion date: October 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Participant has been previously treated with an anti-PD-[L]1 or anti-programmed death-ligand 2 (anti-PD-[L]2) agent that resulted in permanent discontinuation due to an AE.
• Participant has been previously treated with an anti-T cell immunoglobulin and mucin domain containing 3 (anti-TIM-3) or anti-cytotoxic T lymphocyte associated protein 4 (CTLA 4) agent or docetaxel.
• Participant has a documented sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ros oncogene 1 (ROS-1) mutation. Participants whose tumors have not been tested for these driver mutations and therefore who have unknown driver mutation status are not eligible. Participants with squamous histology do not need to be tested for these driver mutations.
• Participant had radiological or clinical disease progression (i.e., worsening performance status, clinical symptoms, and laboratory data) <=8 weeks after initiation of prior anti-programmed cell death protein 1 (anti-PD-1) or anti-PD-L1 antibody. The clinical disease progression should have been confirmed by a subsequent radiological scan.
• Participant has received radiation to the lung that is >30 gray (Gy) within 6 months prior to the first dose of study treatment.
• Participant has completed palliative radiotherapy within 7 days prior to the first dose of study treatment.
• Participant is ineligible if any of the following hepatic characteristics are present:

a. Alanine aminotransferase (ALT) >2.5 times upper limit normal (ULN) b. ALT and/or aspartate aminotransferase (AST) >1.5 times ULN concomitant with alkaline phosphatase (ALP) >2.5 times ULN; c. Bilirubin >1 times ULN; d. Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per the Investigator's assessment).

• Participant has known new or progressive brain metastases and/or leptomeningeal metastases. Participants who have received prior therapy for their brain metastases and have radiographically stable central nervous system disease may participate, provided they are neurologically stable for at least 4 weeks before study entry and are off corticosteroids within 3 days prior to the first dose of study treatment.
• Participant has tested positive for the following at Screening or within 3 months before the first dose of study treatment: a. Presence of hepatitis B surface antigen. b. Presence of hepatitis C antibody in the absence of a ribonucleic acid (RNA) test for hepatitis C virus. If a confirmatory RNA test is available, a positive test result will exclude a participant, while a negative test result (indicating absence of active infection) will allow the participant to enter into the study.
• Participant has known human immunodeficiency virus (HIV) (positive for HIV 1 or HIV 2 antibodies).
• Participant has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment.
• Participant has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment of these conditions (including therapeutic thoracentesis or paracentesis) is eligible.
• Participant has current interstitial lung disease, current pneumonitis, or a history of pneumonitis that required the use of glucocorticoids to assist with management.
• Participant has pre-existing peripheral neuropathy that is Grade >=2 by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 criteria.
• Participant has received a live vaccine within 30 days of the first dose of study treatment. Seasonal flu vaccines that do not contain live virus and Coronavirus Disease 2019 (COVID-19) vaccines.
• Participant is unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) for undergoing a biopsy procedure (in cases when a participant does not have an archival biopsy), other than an aspirin dose <=1.3 grams (g) per day, for a 5-day period (8-day) period for long-acting agents, such as piroxicam).

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer, Non-Small Cell
• Lung Neoplasms

Intervention

Biological:
• Cobolimab
Cobolimab will be administered
• Dostarlimab
Dostarlimab will be administered

Drug:
• Docetaxel
Docetaxel will be administered

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Cipoletti, Rio Negro	Río Negro
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires
Argentina	GSK Investigational Site	Florida	Buenos Aires
Argentina	GSK Investigational Site	La Rioja
Argentina	GSK Investigational Site	Pergamino	Buenos Aires
Argentina	GSK Investigational Site	Rosario	Santa Fe
Argentina	GSK Investigational Site	Viedma	Río Negro
Australia	GSK Investigational Site	Ballarat	Victoria
Australia	GSK Investigational Site	Hobart	Tasmania
Australia	GSK Investigational Site	Kurralta Park	South Australia
Australia	GSK Investigational Site	Melbourne	Victoria
Australia	GSK Investigational Site	South Brisbane	South Australia
Belgium	GSK Investigational Site	Aalst
Belgium	GSK Investigational Site	Hasselt
Belgium	GSK Investigational Site	Kortrijk
Brazil	GSK Investigational Site	Blumenau	Santa Catarina
Brazil	GSK Investigational Site	Fortaleza	Ceará
Brazil	GSK Investigational Site	Ondina	Bahia
Brazil	GSK Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	GSK Investigational Site	Rio de Janeiro
Brazil	GSK Investigational Site	Rio de Janeiro
Brazil	GSK Investigational Site	São Paulo
Canada	GSK Investigational Site	Greenfield Park	Quebec
Canada	GSK Investigational Site	Kingston	Ontario
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Oshawa	Ontario
Canada	GSK Investigational Site	Sudbury	Ontario
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Kuopio
Finland	GSK Investigational Site	Tampere
Finland	GSK Investigational Site	Turku
France	GSK Investigational Site	Créteil Cedex
France	GSK Investigational Site	Grenoble cedex 9
France	GSK Investigational Site	Marseille
France	GSK Investigational Site	Nice Cedex 2
France	GSK Investigational Site	Quimper cedex
France	GSK Investigational Site	Rennes Cedex 9
France	GSK Investigational Site	Tours cedex 9
Germany	GSK Investigational Site	Augsburg	Bayern
Germany	GSK Investigational Site	Bad Berka	Thueringen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bonn	Nordrhein-Westfalen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Frankfurt	Hessen
Germany	GSK Investigational Site	Frankfurt am Main	Hessen
Germany	GSK Investigational Site	Halle	Sachsen-Anhalt
Germany	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Karlsruhe	Baden-Wuerttemberg
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Oldenburg	Niedersachsen
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Larissa
Greece	GSK Investigational Site	Patras
Greece	GSK Investigational Site	Thessaloniki
Greece	GSK Investigational Site	Thessaloniki
Greece	GSK Investigational Site	Thessaloniki
Italy	GSK Investigational Site	Avellino	Campania
Italy	GSK Investigational Site	Firenze	Toscana
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Monza	Lombardia
Italy	GSK Investigational Site	Napoli	Campania
Italy	GSK Investigational Site	Orbassano (TO)	Piemonte
Italy	GSK Investigational Site	Perugia	Umbria
Italy	GSK Investigational Site	Siena	Toscana
Italy	GSK Investigational Site	Torrette (AN)	Marche
Japan	GSK Investigational Site	Kyoto
Japan	GSK Investigational Site	Miyagi
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Yamaguchi
Korea, Republic of	GSK Investigational Site	Busan
Korea, Republic of	GSK Investigational Site	Cheongju-si, Chungcheongbuk-do
Korea, Republic of	GSK Investigational Site	Daegu-si
Korea, Republic of	GSK Investigational Site	Gyeonggi-do
Korea, Republic of	GSK Investigational Site	Seongnam-si, Gyeonggi-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	Seoul
Korea, Republic of	GSK Investigational Site	Suwon-Si
Mexico	GSK Investigational Site	Benito Juarez	Ciudad De Mexico
Mexico	GSK Investigational Site	Guadalajara	Jalisco
Mexico	GSK Investigational Site	Mexico	Ciudad De Mexico
Mexico	GSK Investigational Site	Mexico City	Ciudad De Mexico
Mexico	GSK Investigational Site	Mexico City
Mexico	GSK Investigational Site	Monterrey	Nuevo León
Mexico	GSK Investigational Site	Puebla
Netherlands	GSK Investigational Site	Amersfoort
Netherlands	GSK Investigational Site	Enschede
Netherlands	GSK Investigational Site	Groningen
Netherlands	GSK Investigational Site	Harderwijk
Netherlands	GSK Investigational Site	Nijmegen
Netherlands	GSK Investigational Site	Utrecht
Netherlands	GSK Investigational Site	Zwolle
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Gdynia
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Olsztyn
Poland	GSK Investigational Site	Pila
Poland	GSK Investigational Site	Poznan
Romania	GSK Investigational Site	Bucuresti
Romania	GSK Investigational Site	Craiova
Romania	GSK Investigational Site	Craiova
Romania	GSK Investigational Site	Otopeni
Romania	GSK Investigational Site	Timisoara
Russian Federation	GSK Investigational Site	Chelyabinsk
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Pushkin
Russian Federation	GSK Investigational Site	Saint-Petersburg
Spain	GSK Investigational Site	Badalona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Burgos
Spain	GSK Investigational Site	Cordoba
Spain	GSK Investigational Site	La Coruña
Spain	GSK Investigational Site	Las Palmas De Gran Canaria
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Majadahonda (Madrid)
Spain	GSK Investigational Site	Malaga
Spain	GSK Investigational Site	Valencia
Sweden	GSK Investigational Site	Gävle
Sweden	GSK Investigational Site	Solna
Sweden	GSK Investigational Site	Uppsala
Taiwan	GSK Investigational Site	Hsinchu City
Taiwan	GSK Investigational Site	New Taipei City
Taiwan	GSK Investigational Site	Taichung
Taiwan	GSK Investigational Site	Taipei City
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Dusit
Thailand	GSK Investigational Site	Hat Yai
Thailand	GSK Investigational Site	Khlong Luang
Thailand	GSK Investigational Site	Muang
Turkey	GSK Investigational Site	Adana
Turkey	GSK Investigational Site	Antalya
Turkey	GSK Investigational Site	Izmir
United Kingdom	GSK Investigational Site	Edinburgh
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Manchester
United Kingdom	GSK Investigational Site	Whitchurch, Cardiff
United States	GSK Investigational Site	Billings	Montana
United States	GSK Investigational Site	Bronx	New York
United States	GSK Investigational Site	Cerritos	California
United States	GSK Investigational Site	Edgewood	Kentucky
United States	GSK Investigational Site	Fountain Valley	California
United States	GSK Investigational Site	Fredericksburg	Virginia
United States	GSK Investigational Site	Honolulu	Hawaii
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Iowa City	Iowa
United States	GSK Investigational Site	Knoxville	Tennessee
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Mineola	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Northport	New York
United States	GSK Investigational Site	Norwich	Connecticut
United States	GSK Investigational Site	Oakland	California
United States	GSK Investigational Site	Orange City	Florida
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Roseville	California
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Santa Clara	California
United States	GSK Investigational Site	Sioux Falls	South Dakota
United States	GSK Investigational Site	Tacoma	Washington
United States	GSK Investigational Site	Vallejo	California
United States	GSK Investigational Site	Walnut Creek	California
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Finland,  France,  Germany,  Greece,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Romania,  Russian Federation,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS) in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving docetaxel alone	OS is defined as survival from the date of randomization to the date of death by any cause	Up to 44 months
Primary	OS in participants receiving dostarlimab + docetaxel relative to participants receiving docetaxel alone	OS is defined as survival from the date of randomization to the date of death by any cause	Up to 44 months
Secondary	OS in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving dostarlimab + docetaxel	OS is defined as survival from the date of randomization to the date of death by any cause	Up to 44 months
Secondary	Objective response rate (ORR)	Confirmed ORR is defined as the proportion of participants who have achieved confirmed complete response (CR) or confirmed partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on Investigator assessment	Up to 44 months
Secondary	Progression free survival (PFS)	PFS is defined as the length of time until disease progression, from the time of randomization to the earliest date of assessment of disease progression based on RECIST version 1.1 by Investigator assessment or death by any cause	Up to 44 months
Secondary	Duration of response (DOR)	DOR is defined as the time from first documented response (CR/PR) until the time of first documentation of disease progression based on RECIST version 1.1 by Investigator assessment or death, whichever occurs first	Up to 44 months
Secondary	Time to deterioration (TTD)	TTD in lung cancer is defined as time from randomization to meaningful deterioration on a composite endpoint of dyspnea, chest pain, and cough, from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 13 item Lung Cancer Module (EORTC QLQ LC13)	Up to 44 months
Secondary	Change from Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 item Core Module (EORTC QLQ-C30) assessment	EORTC QLQ-C30 is a questionnaire used to measure health related quality of life (HRQoL) in participants with cancer.	Baseline (Day 1) and up to 44 months
Secondary	Change from Baseline in the EORTC QLQ LC13 assessment	EORTC QLQ LC13 is a lung cancer specific questionnaire module designed to supplement the EORTC QLQ C30.	Baseline (Day 1) and up to 44 months
Secondary	Number of participants with serious adverse events (SAEs)		From consent signature (Day -28) until the 90 day post last dose follow-up
Secondary	Number of participants with treatment-emergent adverse events (TEAEs) and immune related adverse event (irAEs)		From consent signature (Day -28) until the 30 day post last dose follow-up
Secondary	Number of participants with TEAEs leading to death		From consent signature (Day -28) until the 90 day post last dose follow-up
Secondary	Number of participants with adverse events (AEs) leading to discontinuation		From consent signature (Day -28) until the 30 day post last dose follow-up
Secondary	Number of participants with clinically significant changes in hematology, clinical chemistry, thyroid function and urinalysis lab parameters	Blood and urine samples will be collected for the assessment of hematology, clinical chemistry, thyroid function and urinalysis lab parameters	From consent signature (Day -28) until the 90 day post last dose follow-up
Secondary	Number of participants with clinically significant changes in vital signs and Electrocardiogram (ECG) Parameters		From consent signature (Day -28) until the 90 day post last dose follow-up
Secondary	Number of participants with indicated Eastern Cooperative Oncology Group (ECOG) performance status	Performance status will be assessed using the ECOG performance status scale. Scales range from grade 0 to 4, grade 0 denoting fully active and grade 4 completely disabled.	From consent signature (Day -28) until the 90 day post last dose follow-up
Secondary	Number of participants with usage of concomitant medications		From consent signature (Day -28) until the 90 day post last dose follow-up
Secondary	Number of participants with abnormal physical examinations		From consent signature (Day -28) until the 90 day post last dose follow-up