Last updated on June 2020

Phase II Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Non-small Cell Lung Cancer (NSCLC)


Brief description of study

This study will compare the clinical activity of novel immune-oncology agents (in combination or as single agents) to standard of care in participants with relapsed/refractory advanced NSCLC. The study will initially evaluate two treatment regimens/arms. Additional regimens/arms may be added via future protocol amendment(s). Participants will be stratified by histology (squamous vs. non-squamous) and line of anti-programmed cell death ligand 1 (PD[L]1) therapy (first vs. second line). Initially, the study will evaluate the GSK3359609 inducible T-cell co-stimulator (ICOS) agonist in combination with SoC docetaxel compared to docetaxel alone (sub-study 1). SoC arm will be the common comparison arm across all sub-studies. At study start, subjects will be randomized to the study at a ratio of 1:2 to Arm 1 (docetaxel) and Arm 2 (ICOS agonist + docetaxel). The study will consist of three periods: Screening, Treatment, and Follow-Up. There will be approximately 105 participants enrolled in the study initially. Treatment will continue for approximately 2 years and participants will be followed for survival during the follow-up period.

Clinical Study Identifier: NCT03739710

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Kansas City, MO United States
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Pinehurst, NC United States
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Nashville, TN United States
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Dallas, TX United States
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Villejuif Cedex, France
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Cheongju-si, Chungcheongbuk-do, Korea, Republic of
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Gyeonggi-do, Korea, Republic of
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Seongnam, Korea, Republic of
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Seoul, Korea, Republic of
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Maastricht, Netherlands
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Chelyabinsk, Russian Federation
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Saint-Petersburg, Russian Federation
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Saint Louis, MO United States
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Atlanta, GA United States
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Southfield, MI United States
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Hackensack, NJ United States
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Bellevue, WA United States
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Bronx, NY United States
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Chattanooga, TN United States
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Recruitment Status: Open


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