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
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.
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.
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).
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 192 Locations for this study
Cerritos California, 90703, United States
Fountain Valley California, 92708, United States
Los Angeles California, 90034, United States
Oakland California, 94611, United States
Roseville California, 95661, United States
San Francisco California, 94115, United States
San Francisco California, 94121, United States
Santa Clara California, 95051, United States
Vallejo California, 94589, United States
Walnut Creek California, 94596, United States
Norwich Connecticut, 06360, United States
Washington District of Columbia, 20422, United States
Orange City Florida, 32763, United States
Honolulu Hawaii, 96819, United States
Iowa City Iowa, 52242, United States
Edgewood Kentucky, 41017, United States
Louisville Kentucky, 42061, United States
Billings Montana, 59102, United States
Las Vegas Nevada, 89144, United States
Bronx New York, 10468, United States
Mineola New York, 11501, United States
New York New York, 10010, United States
New York New York, 10016, United States
Northport New York, 11768, United States
White Plains New York, 10601, United States
Greensboro North Carolina, 27403, United States
Pittsburgh Pennsylvania, 15224, United States
Pittsburgh Pennsylvania, 15232, United States
Sioux Falls South Dakota, 57105, United States
Knoxville Tennessee, 37916, United States
Memphis Tennessee, 38104, United States
Houston Texas, 77030, United States
Fredericksburg Virginia, 22408, United States
Tacoma Washington, 98405, United States
Ciudad Autonoma de Buenos Aires Buenos Aires, 1425, Argentina
Florida Buenos Aires, 1602, Argentina
Pergamino Buenos Aires, B2700, Argentina
Cipoletti, Rio Negro Río Negro, R8324, Argentina
Viedma Río Negro, R8500, Argentina
Rosario Santa Fe, S2000, Argentina
Ciudad Autónoma de Buenos Aires , C1426, Argentina
La Rioja , F5300, Argentina
Woolloongabba Queensland, 4102, Australia
Kurralta Park South Australia, 5037, Australia
South Brisbane South Australia, 4101, Australia
Hobart Tasmania, 7000, Australia
Ballarat Victoria, 3350, Australia
Melbourne Victoria, 3004, Australia
Aalst , 9300, Belgium
Hasselt , 3500, Belgium
Kortrijk , 8500, Belgium
Ondina Bahia, 40170, Brazil
Fortaleza Ceará, 60336, Brazil
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Blumenau Santa Catarina, 89010, Brazil
Rio de Janeiro , 22061, Brazil
Rio de Janeiro , 22250, Brazil
São Paulo , 04014, Brazil
Kingston Ontario, K7L 2, Canada
Oshawa Ontario, L1G 2, Canada
Sudbury Ontario, P3E 5, Canada
Greenfield Park Quebec, J4V 2, Canada
Montreal Quebec, H3T 1, Canada
Helsinki , 00180, Finland
Kuopio , 70210, Finland
Tampere , 33520, Finland
Turku , 20520, Finland
Créteil Cedex , 94010, France
Grenoble cedex 9 , 38043, France
Marseille , 13009, France
Nice Cedex 2 , 06189, France
Quimper cedex , 29107, France
Rennes Cedex 9 , 35033, France
Tours cedex 9 , 37044, France
Heidelberg Baden-Wuerttemberg, 69126, Germany
Karlsruhe Baden-Wuerttemberg, 76137, Germany
Augsburg Bayern, 86156, Germany
Muenchen Bayern, 80336, Germany
Muenchen Bayern, 81925, Germany
Frankfurt am Main Hessen, 60590, Germany
Frankfurt Hessen, 60488, Germany
Oldenburg Niedersachsen, 26121, Germany
Bonn Nordrhein-Westfalen, 53113, Germany
Essen Nordrhein-Westfalen, 45147, Germany
Koeln Nordrhein-Westfalen, 51109, Germany
Halle Sachsen-Anhalt, 06120, Germany
Dresden Sachsen, 01307, Germany
Bad Berka Thueringen, 99437, Germany
Berlin , 12200, Germany
Athens , 115 2, Greece
Athens , 11526, Greece
Athens , 11528, Greece
Athens , 12462, Greece
Larissa , 41100, Greece
Patras , 26504, Greece
Thessaloniki , 55236, Greece
Thessaloniki , 570 0, Greece
Thessaloniki , 57010, Greece
Avellino Campania, 83100, Italy
Napoli Campania, 80131, Italy
Milano Lombardia, 20132, Italy
Milano Lombardia, 20133, Italy
Monza Lombardia, 20900, Italy
Torrette (AN) Marche, 60126, Italy
Orbassano (TO) Piemonte, 10043, Italy
Firenze Toscana, 50134, Italy
Siena Toscana, 53100, Italy
Perugia Umbria, 06156, Italy
Gunma , 377-0, Japan
Hiroshima , 737-0, Japan
Hyogo , 670-8, Japan
Kyoto , 612-8, Japan
Mie , 515-8, Japan
Miyagi , 981-1, Japan
Okayama , 700-8, Japan
Osaka , 560-8, Japan
Osaka , 591-8, Japan
Tottori , 683-8, Japan
Yamaguchi , 755-0, Japan
Busan , 49241, Korea, Republic of
Cheongju-si, Chungcheongbuk-do , 28644, Korea, Republic of
Daegu-si , 42601, Korea, Republic of
Gyeonggi-do , 10408, Korea, Republic of
Seongnam-si, Gyeonggi-do , 13620, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 08308, Korea, Republic of
Suwon-Si , 443-7, Korea, Republic of
Cdmx Ciudad De Mexico, 14050, Mexico
Mexico City Ciudad De Mexico, 06700, Mexico
Mexico Ciudad De Mexico, 03100, Mexico
Guadalajara Jalisco, 44280, Mexico
Monterrey Nuevo León, 64460, Mexico
Mexico City , CP 14, Mexico
Puebla , 72560, Mexico
Amersfoort , 3813 , Netherlands
Enschede , 7512 , Netherlands
Groningen , 9713 , Netherlands
Harderwijk , 3844 , Netherlands
Nijmegen , 6525 , Netherlands
Utrecht , 3543 , Netherlands
Zwolle , 8025 , Netherlands
Bydgoszcz , 85-79, Poland
Gdynia , 81-51, Poland
Lodz , 90-33, Poland
Olsztyn , 10-35, Poland
Pila , 64-92, Poland
Poznan , 60-69, Poland
Bucuresti , 02138, Romania
Craiova , 20034, Romania
Craiova , 20038, Romania
Otopeni , 07510, Romania
Timisoara , 30023, Romania
Chelyabinsk , 45404, Russian Federation
Moscow , 14342, Russian Federation
Pushkin , 19660, Russian Federation
Saint-Petersburg , 19702, Russian Federation
Badalona , 08916, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Burgos , 09006, Spain
Cordoba , 14004, Spain
La Coruña , 15006, Spain
Las Palmas De Gran Canaria , 35016, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Majadahonda (Madrid) , 28222, Spain
Malaga , 29010, Spain
Valencia , 46026, Spain
Gävle , SE-80, Sweden
Solna , 171 6, Sweden
Uppsala , SE-75, Sweden
Hsinchu City , 300, Taiwan
New Taipei City , 23561, Taiwan
Taichung , 407, Taiwan
Taipei City , 11217, Taiwan
Dusit , 10300, Thailand
Hat Yai , 90110, Thailand
Khlong Luang , 12120, Thailand
Muang , 40002, Thailand
Adana , 1120, Turkey
Antalya , 07020, Turkey
Izmir , 35600, Turkey
Edinburgh , EH4 2, United Kingdom
London , SE1 9, United Kingdom
London , W1G 6, United Kingdom
Manchester , M20 4, United Kingdom
Whitchurch, Cardiff , CF14 , United Kingdom
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.