PCRC_S1400

Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer

Experimental: S1400A Arm I (MEDI4736)
Patients with tumors that do not match one of the currently active drug-biomarker combinations randomized to Arm I receive anti-B7H1 monoclonal antibody MEDI4736 IV over 60 minutes on day 1. Courses repeat every 2 weeks for 12 months in the absence of disease progression or unacceptable toxicity. Upon evidence of progressive disease following discontinuation of 12 months of treatment, patients may restart treatment for up to 12 additional months.
Active Comparator: S1400A Arm II (docetaxel)
Patients with tumors that do not match one of the currently active drug-biomarker combinations randomized to Arm II receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Experimental: S1400B Arm I (GDC-0032)
Patients tumors positive for PI3KCA randomized to Arm I receive PI3 kinase inhibitor GDC-0032 PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Active Comparator: S1400B Arm II (docetaxel)
Patients with tumors positive for PI3KCA randomized to Arm II receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Experimental: S1400C Arm I (palbociclib)
Patients with tumors positive for CDK4/6, CCND1, CCND2, and CCND3 randomized to Arm I receive palbociclib isethionate PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Active Comparator: S1400C Arm II (docetaxel)
Patients with tumors positive for CDK4, CCND1, CCND2, and CCND3 randomized to Arm II receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Experimental: S1400D Arm I (AZD4547)
Patients with tumors positive for FGFR1, FGFR2, and FGFR3 randomized to Arm I receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Active Comparator: S1400D Arm II (docetaxel)
Patients with tumors positive for FGFR1, FGFR2, and FGFR3 randomized to Arm II receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Experimental: S1400E Arm I (rilotumumab, erlotinib)
Patients with tumors positive for HGF/c-MET randomized to Arm I receive rilotumumab IV on day 1 and erlotinib hydrochloride PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Active Comparator: S1400E Arm II (erlotinib)
Patients with tumors positive for HGF/c-MET randomized to Arm II receive erlotinib hydrochloride PO daily. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Phase II/III
NCT02154490
Oncology
Lung
Gary Goodman, M.D.
SWOG
Brenda Fisher

The Pacific Cancer Research Consortium clinical trials are offered at multiple locations throughout Oregon, Washington, Alaska, California, and Idaho. To find a location near you, please contact the Patient Engagement Center at 844-552-2734.