Lung Cancer Clinical Trial

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

Summary

This is a multi-center, parallel group treatment, Phase 2 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.

View Eligibility Criteria

Eligibility Criteria

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).

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

758

Study ID:

NCT04655976

Recruitment Status:

Active, not recruiting

Sponsor:

GlaxoSmithKline

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There are 184 Locations for this study

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GSK Investigational Site
Cerritos California, 90703, United States
GSK Investigational Site
Fountain Valley California, 92708, United States
GSK Investigational Site
Los Angeles California, 90034, United States
GSK Investigational Site
Oakland California, 94611, United States
GSK Investigational Site
Roseville California, 95661, United States
GSK Investigational Site
San Francisco California, 94115, United States
GSK Investigational Site
San Francisco California, 94121, United States
GSK Investigational Site
Santa Clara California, 95051, United States
GSK Investigational Site
Vallejo California, 94589, United States
GSK Investigational Site
Walnut Creek California, 94596, United States
GSK Investigational Site
Norwich Connecticut, 06360, United States
GSK Investigational Site
Washington District of Columbia, 20422, United States
GSK Investigational Site
Orange City Florida, 32763, United States
GSK Investigational Site
Honolulu Hawaii, 96819, United States
GSK Investigational Site
Iowa City Iowa, 52242, United States
GSK Investigational Site
Edgewood Kentucky, 41017, United States
GSK Investigational Site
Louisville Kentucky, 42061, United States
GSK Investigational Site
Billings Montana, 59102, United States
GSK Investigational Site
Las Vegas Nevada, 89144, United States
GSK Investigational Site
Bronx New York, 10468, United States
GSK Investigational Site
Mineola New York, 11501, United States
GSK Investigational Site
New York New York, 10010, United States
GSK Investigational Site
New York New York, 10016, United States
GSK Investigational Site
Northport New York, 11768, United States
GSK Investigational Site
White Plains New York, 10601, United States
GSK Investigational Site
Pittsburgh Pennsylvania, 15224, United States
GSK Investigational Site
Pittsburgh Pennsylvania, 15232, United States
GSK Investigational Site
Sioux Falls South Dakota, 57105, United States
GSK Investigational Site
Knoxville Tennessee, 37916, United States
GSK Investigational Site
Memphis Tennessee, 38104, United States
GSK Investigational Site
Houston Texas, 77030, United States
GSK Investigational Site
Fredericksburg Virginia, 22408, United States
GSK Investigational Site
Tacoma Washington, 98405, United States
GSK Investigational Site
Ciudad Autonoma de Buenos Aires Buenos Aires, 1425, Argentina
GSK Investigational Site
Florida Buenos Aires, 1602, Argentina
GSK Investigational Site
Pergamino Buenos Aires, B2700, Argentina
GSK Investigational Site
Cipoletti, Rio Negro Río Negro, R8324, Argentina
GSK Investigational Site
Viedma Río Negro, R8500, Argentina
GSK Investigational Site
Rosario Santa Fe, S2000, Argentina
GSK Investigational Site
Ciudad Autónoma de Buenos Aires , C1426, Argentina
GSK Investigational Site
La Rioja , F5300, Argentina
GSK Investigational Site
Kurralta Park South Australia, 5037, Australia
GSK Investigational Site
South Brisbane South Australia, 4101, Australia
GSK Investigational Site
Hobart Tasmania, 7000, Australia
GSK Investigational Site
Ballarat Victoria, 3350, Australia
GSK Investigational Site
Melbourne Victoria, 3004, Australia
GSK Investigational Site
Aalst , 9300, Belgium
GSK Investigational Site
Hasselt , 3500, Belgium
GSK Investigational Site
Kortrijk , 8500, Belgium
GSK Investigational Site
Ondina Bahia, 40170, Brazil
GSK Investigational Site
Fortaleza Ceará, 60336, Brazil
GSK Investigational Site
Porto Alegre Rio Grande Do Sul, 90610, Brazil
GSK Investigational Site
Blumenau Santa Catarina, 89010, Brazil
GSK Investigational Site
Rio de Janeiro , 22061, Brazil
GSK Investigational Site
Rio de Janeiro , 22250, Brazil
GSK Investigational Site
São Paulo , 04014, Brazil
GSK Investigational Site
Kingston Ontario, K7L 2, Canada
GSK Investigational Site
Oshawa Ontario, L1G 2, Canada
GSK Investigational Site
Sudbury Ontario, P3E 5, Canada
GSK Investigational Site
Greenfield Park Quebec, J4V 2, Canada
GSK Investigational Site
Montreal Quebec, H3T 1, Canada
GSK Investigational Site
Helsinki , 00180, Finland
GSK Investigational Site
Kuopio , 70210, Finland
GSK Investigational Site
Tampere , 33520, Finland
GSK Investigational Site
Turku , 20520, Finland
GSK Investigational Site
Créteil Cedex , 94010, France
GSK Investigational Site
Grenoble cedex 9 , 38043, France
GSK Investigational Site
Marseille , 13009, France
GSK Investigational Site
Nice Cedex 2 , 06189, France
GSK Investigational Site
Quimper cedex , 29107, France
GSK Investigational Site
Rennes Cedex 9 , 35033, France
GSK Investigational Site
Tours cedex 9 , 37044, France
GSK Investigational Site
Heidelberg Baden-Wuerttemberg, 69126, Germany
GSK Investigational Site
Karlsruhe Baden-Wuerttemberg, 76137, Germany
GSK Investigational Site
Augsburg Bayern, 86156, Germany
GSK Investigational Site
Muenchen Bayern, 80336, Germany
GSK Investigational Site
Muenchen Bayern, 81925, Germany
GSK Investigational Site
Frankfurt am Main Hessen, 60590, Germany
GSK Investigational Site
Frankfurt Hessen, 60488, Germany
GSK Investigational Site
Oldenburg Niedersachsen, 26121, Germany
GSK Investigational Site
Bonn Nordrhein-Westfalen, 53113, Germany
GSK Investigational Site
Essen Nordrhein-Westfalen, 45147, Germany
GSK Investigational Site
Koeln Nordrhein-Westfalen, 51109, Germany
GSK Investigational Site
Halle Sachsen-Anhalt, 06120, Germany
GSK Investigational Site
Dresden Sachsen, 01307, Germany
GSK Investigational Site
Bad Berka Thueringen, 99437, Germany
GSK Investigational Site
Berlin , 12200, Germany
GSK Investigational Site
Athens , 115 2, Greece
GSK Investigational Site
Athens , 11526, Greece
GSK Investigational Site
Athens , 11528, Greece
GSK Investigational Site
Athens , 12462, Greece
GSK Investigational Site
Larissa , 41100, Greece
GSK Investigational Site
Patras , 26504, Greece
GSK Investigational Site
Thessaloniki , 55236, Greece
GSK Investigational Site
Thessaloniki , 570 0, Greece
GSK Investigational Site
Thessaloniki , 57010, Greece
GSK Investigational Site
Avellino Campania, 83100, Italy
GSK Investigational Site
Napoli Campania, 80131, Italy
GSK Investigational Site
Milano Lombardia, 20132, Italy
GSK Investigational Site
Milano Lombardia, 20133, Italy
GSK Investigational Site
Monza Lombardia, 20900, Italy
GSK Investigational Site
Torrette (AN) Marche, 60126, Italy
GSK Investigational Site
Orbassano (TO) Piemonte, 10043, Italy
GSK Investigational Site
Firenze Toscana, 50134, Italy
GSK Investigational Site
Siena Toscana, 53100, Italy
GSK Investigational Site
Perugia Umbria, 06156, Italy
GSK Investigational Site
Kyoto , 612-8, Japan
GSK Investigational Site
Miyagi , 981-1, Japan
GSK Investigational Site
Osaka , 591-8, Japan
GSK Investigational Site
Yamaguchi , 755-0, Japan
GSK Investigational Site
Busan , 49241, Korea, Republic of
GSK Investigational Site
Cheongju-si, Chungcheongbuk-do , 28644, Korea, Republic of
GSK Investigational Site
Daegu-si , 42601, Korea, Republic of
GSK Investigational Site
Gyeonggi-do , 10408, Korea, Republic of
GSK Investigational Site
Seongnam-si, Gyeonggi-do , 13620, Korea, Republic of
GSK Investigational Site
Seoul , 03722, Korea, Republic of
GSK Investigational Site
Seoul , 05505, Korea, Republic of
GSK Investigational Site
Seoul , 06351, Korea, Republic of
GSK Investigational Site
Seoul , 08308, Korea, Republic of
GSK Investigational Site
Suwon-Si , 443-7, Korea, Republic of
GSK Investigational Site
Benito Juarez Ciudad De Mexico, 03810, Mexico
GSK Investigational Site
Mexico City Ciudad De Mexico, 06700, Mexico
GSK Investigational Site
Mexico Ciudad De Mexico, 03100, Mexico
GSK Investigational Site
Guadalajara Jalisco, 44280, Mexico
GSK Investigational Site
Monterrey Nuevo León, 64460, Mexico
GSK Investigational Site
Mexico City , CP 14, Mexico
GSK Investigational Site
Puebla , 72560, Mexico
GSK Investigational Site
Amersfoort , 3813 , Netherlands
GSK Investigational Site
Enschede , 7512 , Netherlands
GSK Investigational Site
Groningen , 9713 , Netherlands
GSK Investigational Site
Harderwijk , 3844 , Netherlands
GSK Investigational Site
Nijmegen , 6525 , Netherlands
GSK Investigational Site
Utrecht , 3543 , Netherlands
GSK Investigational Site
Zwolle , 8025 , Netherlands
GSK Investigational Site
Bydgoszcz , 85-79, Poland
GSK Investigational Site
Gdynia , 81-51, Poland
GSK Investigational Site
Lodz , 90-33, Poland
GSK Investigational Site
Olsztyn , 10-35, Poland
GSK Investigational Site
Pila , 64-92, Poland
GSK Investigational Site
Poznan , 60-69, Poland
GSK Investigational Site
Bucuresti , 02138, Romania
GSK Investigational Site
Craiova , 20034, Romania
GSK Investigational Site
Craiova , 20038, Romania
GSK Investigational Site
Otopeni , 07510, Romania
GSK Investigational Site
Timisoara , 30023, Romania
GSK Investigational Site
Chelyabinsk , 45404, Russian Federation
GSK Investigational Site
Moscow , 14342, Russian Federation
GSK Investigational Site
Pushkin , 19660, Russian Federation
GSK Investigational Site
Saint-Petersburg , 19702, Russian Federation
GSK Investigational Site
Badalona , 08916, Spain
GSK Investigational Site
Barcelona , 08035, Spain
GSK Investigational Site
Barcelona , 08036, Spain
GSK Investigational Site
Burgos , 09006, Spain
GSK Investigational Site
Cordoba , 14004, Spain
GSK Investigational Site
La Coruña , 15006, Spain
GSK Investigational Site
Las Palmas De Gran Canaria , 35016, Spain
GSK Investigational Site
Madrid , 28007, Spain
GSK Investigational Site
Madrid , 28034, Spain
GSK Investigational Site
Madrid , 28041, Spain
GSK Investigational Site
Madrid , 28046, Spain
GSK Investigational Site
Madrid , 28050, Spain
GSK Investigational Site
Majadahonda (Madrid) , 28222, Spain
GSK Investigational Site
Malaga , 29010, Spain
GSK Investigational Site
Valencia , 46026, Spain
GSK Investigational Site
Gävle , SE-80, Sweden
GSK Investigational Site
Solna , 171 6, Sweden
GSK Investigational Site
Uppsala , SE-75, Sweden
GSK Investigational Site
Hsinchu City , 300, Taiwan
GSK Investigational Site
New Taipei City , 23561, Taiwan
GSK Investigational Site
Taichung , 407, Taiwan
GSK Investigational Site
Taipei City , 11217, Taiwan
GSK Investigational Site
Bangkok , 10210, Thailand
GSK Investigational Site
Dusit , 10300, Thailand
GSK Investigational Site
Hat Yai , 90110, Thailand
GSK Investigational Site
Khlong Luang , 12120, Thailand
GSK Investigational Site
Muang , 40002, Thailand
GSK Investigational Site
Adana , 1120, Turkey
GSK Investigational Site
Antalya , 07020, Turkey
GSK Investigational Site
Izmir , 35600, Turkey
GSK Investigational Site
Edinburgh , EH4 2, United Kingdom
GSK Investigational Site
London , SE1 9, United Kingdom
GSK Investigational Site
London , W1G 6, United Kingdom
GSK Investigational Site
Manchester , M20 4, United Kingdom
GSK Investigational Site
Whitchurch, Cardiff , CF14 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

758

Study ID:

NCT04655976

Recruitment Status:

Active, not recruiting

Sponsor:


GlaxoSmithKline

How clear is this clinincal trial information?

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