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-PD-(L)1 Therapy and Chemotherapy

Last updated: November 4, 2024
Sponsor: GlaxoSmithKline
Overall Status: Active - Not Recruiting

Phase

3

Condition

N/A

Treatment

Docetaxel

Dostarlimab

Cobolimab

Clinical Study ID

NCT04655976
213410
2020-003433-37
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

  • Participant has received no more than 2 prior lines of therapy for advanced ormetastatic 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)1antibody.

  • Participant has measurable disease.

  • Participant has documented radiographic disease progression on prior platinum basedchemotherapy 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 metastaticdisease. If archival tissue is not available, the participant must undergo biopsyprior 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

Exclusion Criteria:

  • Participant has been previously treated with an anti-PD-[L]1 or anti-programmeddeath-ligand 2 (anti-PD-[L]2) agent that resulted in permanent discontinuation dueto an AE.

  • Participant has been previously treated with an anti-T cell immunoglobulin and mucindomain 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. Participantswhose tumors have not been tested for these driver mutations and therefore who haveunknown driver mutation status are not eligible. Participants with squamoushistology do not need to be tested for these driver mutations.

  • Participant had radiological or clinical disease progression (i.e., worseningperformance status, clinical symptoms, and laboratory data) <=8 weeks afterinitiation of prior anti-programmed cell death protein 1 (anti-PD-1) or anti-PD-L1antibody. The clinical disease progression should have been confirmed by asubsequent radiological scan.

  • Participant has received radiation to the lung that is >30 gray (Gy) within 6 monthsprior to the first dose of study treatment.

  • Participant has completed palliative radiotherapy within 7 days prior to the firstdose of study treatment.

  • Participant is ineligible if any of the following hepatic characteristics arepresent: a. Alanine aminotransferase (ALT) >2.5 times upper limit normal (ULN) b.ALT and/or aspartate aminotransferase (AST) >1.5 times ULN concomitant with alkalinephosphatase (ALP) >2.5 times ULN; c. Bilirubin >1 times ULN; d. Current active liveror biliary disease (with the exception of Gilbert's syndrome or asymptomaticgallstones, liver metastases, or otherwise stable chronic liver disease per theInvestigator's assessment).

  • Participant has known new or progressive brain metastases and/or leptomeningealmetastases. Participants who have received prior therapy for their brain metastasesand have radiographically stable central nervous system disease may participate,provided they are neurologically stable for at least 4 weeks before study entry andare 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 monthsbefore the first dose of study treatment: a. Presence of hepatitis B surfaceantigen. 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, apositive test result will exclude a participant, while a negative test result (indicating absence of active infection) will allow the participant to enter intothe 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 thepast 2 years, is immunocompromised in the opinion of the Investigator, or isreceiving systemic immunosuppressive treatment.

  • Participant has symptomatic ascites or pleural effusion. A participant who isclinically stable following treatment of these conditions (including therapeuticthoracentesis or paracentesis) is eligible.

  • Participant has current interstitial lung disease, current pneumonitis, or a historyof pneumonitis that required the use of glucocorticoids to assist with management.

  • Participant has pre-existing peripheral neuropathy that is Grade >=2 by NationalCancer 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 studytreatment. Seasonal flu vaccines that do not contain live virus and CoronavirusDisease 2019 (COVID-19) vaccines.

  • Participant is unable to interrupt aspirin or other non-steroidal anti-inflammatorydrugs (NSAIDs) for undergoing a biopsy procedure (in cases when a participant doesnot 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 Design

Total Participants: 758
Treatment Group(s): 3
Primary Treatment: Docetaxel
Phase: 3
Study Start date:
December 08, 2020
Estimated Completion Date:
October 31, 2025

Connect with a study center

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    Ciudad Autonoma de Buenos Aires, Buenos Aires 1425
    Argentina

    Site Not Available

  • GSK Investigational Site

    Cipoletti, Rio Negro, Río Negro R8324CVE
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    Site Not Available

  • GSK Investigational Site

    Buenos Aires, C1426ABP
    Argentina

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    Cipoletti Rio Negro, R8324CVE
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  • GSK Investigational Site

    Ciudad AutOnoma de Buenos Aires, C1426ABP
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    Ciudad Autonoma de Buenos Aire, 1425
    Argentina

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    Ciudad Autónoma de Buenos Aires, C1426ABP
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    Florida, 1602
    Argentina

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    La Rioja, F5300COE
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    Pergamino, B2700CPM
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    Rosario, S2000DBS
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    Viedma, R8500ACE
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    Blacktown, New South Wales 2148
    Australia

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    South Brisbane, Queensland 4101
    Australia

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    Woolloongabba, Queensland 4102
    Australia

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    Ashford, South Australia 5037
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    Hobart, Tasmania 7000
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    Ballarat, Victoria 3350
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    Mount Waverley, Victoria 3350
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    Aalst, 9300
    Belgium

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    Hasselt, 3500
    Belgium

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    Kortrijk, 8500
    Belgium

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    Ondina, Bahia 40170-110
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    Blumenau, 89010340
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    Fortaleza, 60336-232
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    Porto Alegre, 90610000
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    Rio de Janeiro, 22250-905
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    Nice Cedex 2, 06189
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    Tours cedex 9, 37044
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    Seongnam-si Gyeonggi-do, 13620
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    Seongnam-si, Gyeonggi-do, 13620
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    Seoul, 03722
    Korea, Republic of

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    Suwon Kyunggi-do, 443-721
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    Mexico

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  • GSK Investigational Site

    Cdmx, Ciudad De Mexico 14050
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    Mexico, Ciudad De Mexico 03100
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    Guadalajara, 44280
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    Nijmegen, 6525 GA
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    Utrecht, 3543 AZ
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    Gdynia, 81-519
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    Lodz, 90-338
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    Olsztyn, 10-357
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    Ostroleka, 07-410
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    Pila, 64-920
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    Poznan, 60-693
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    Cluj Napoca, 400015
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    Craiova, 200347
    Romania

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    Craiova Dolj, 200385
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    Otopeni, 075100
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    Timisoara, 300239
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    Moscow, 143423
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    Moscow Region, 143423
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    Pushkin, 196603
    Russian Federation

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    Saint-Petersburg, 197022
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    A CoruNa, 15006
    Spain

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    Badalona, 08916
    Spain

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    Barcelona, 08035
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    Burgos, 09006
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    Cordoba, 140044
    Spain

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    La Coruña, 15006
    Spain

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  • GSK Investigational Site

    Las Palmas De Gran Canar, 35016
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    Las Palmas De Gran Canaria, 35016
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    Madrid, 28222
    Spain

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  • GSK Investigational Site

    Majadahonda (Madrid), 28222
    Spain

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    Malaga, 29010
    Spain

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  • GSK Investigational Site

    Valencia, 46026
    Spain

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    Gavle, SE-801 87
    Sweden

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  • GSK Investigational Site

    Gävle, SE-801 87
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  • GSK Investigational Site

    Solna, 171 64
    Sweden

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    Stockholm, 171 64
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    Uppsala, SE-751 85
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    HsinChu, 300
    Taiwan

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    Hsinchu City, 300
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    New Taipei City, 23561
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    Taichung, 407
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    Taipei, 11217
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    Taipei City, 11217
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    Bangkok, 10210
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    Dusit, 10300
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    Hat Yai, 90110
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    Khlong Luang, 12120
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    Kho Hong Hat Yai, 90110
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    Khon Kaen, 40002
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    Muang, 40002
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    Pathumthani, 12120
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    Adana, 1120
    Turkey

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    London, W1G 6AD
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    Manchester, M20 4BX
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    Whitchurch, Cardiff, CF14 2TL
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    Cerritos, California 90703
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    Fountain Valley, California 92708
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    Los Angeles, California 90034
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    Oakland, California 94611
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    Roseville, California 95661
    United States

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    San Francisco, California 94121
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    Santa Clara, California 95051
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    Walnut Creek, California 94596
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    Whittier, California 90603
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    Norwich, Connecticut 06360
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    Washington, District of Columbia 20422
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    Orange City, Florida 32763
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    Honolulu, Hawaii 96819
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    Iowa City, Iowa 52242
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    Edgewood, Kentucky 41017
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    Louisville, Kentucky 40206
    United States

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    Billings, Montana 59102
    United States

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    Las Vegas, Nevada 89144
    United States

    Site Not Available

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    Bronx, New York 10468
    United States

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    Mineola, New York 11501
    United States

    Site Not Available

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    New York, New York 10016
    United States

    Site Not Available

  • GSK Investigational Site

    Northport, New York 11768
    United States

    Site Not Available

  • GSK Investigational Site

    White Plains, New York 10601
    United States

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    Greensboro, North Carolina 27403
    United States

    Site Not Available

  • GSK Investigational Site

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • GSK Investigational Site

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

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    Knoxville, Tennessee 37916
    United States

    Site Not Available

  • GSK Investigational Site

    Memphis, Tennessee 38104
    United States

    Site Not Available

  • GSK Investigational Site

    Houston, Texas 77030
    United States

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  • GSK Investigational Site

    Fredericksburg, Virginia 22408
    United States

    Site Not Available

  • GSK Investigational Site

    Tacoma, Washington 98405
    United States

    Site Not Available

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