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Protocol No. UW17046
Principal Investigator Leal, Ticiana
Age Group Adult
Sponsor Type Industry; Institutional
Title A Phase II Trial of Chemotherapy plus Pembrolizumab in patients with advanced NSCLC previously treated with PD-1 or PDL1 Inhibitor: Big Ten Cancer Research Consortium BTCRC-LUN15-029
Objective The purpose of this study is to find out if a drug called Pembrolizumab combined with chemotherapy can stop or slow advanced non-small cell lung cancer (NSCLC). Also want to find out if Pembrolizumab combined with chemotherapy is safe to use to treat NSCLC. Pembrolizumab is approved by the FDA, but Pembrolizumab combined with chemotherapy is investigational.
Treatment Pembrolizumab plus physicians choice chemotherapy with either Docetaxel, Premetrexed or Gemcitabine
Description Single arm Phase II, using Pembrolizumab plus standard of care per MD decision.
Histological or cytological evidence of non-small cell lung cancer (any histology)
Must have progressed on or after receiving platinum-based chemotherapy
Must be enrolled on the trial within 6 weeks of last infusion of PD-1 or PD-L1 inhibitor therapy
Adequate organ function and performance status (PS 0 or 1)
Must be fit enough to receive next-line chemotherapy (either gemcitabine, docetaxel, or pemetrexed [non-squamous only])
No evidence of active autoimmune disease requiring systemic treatment within the past 90 days or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
No history of (non-infectious) pneumonitis requiring treatment with corticosteroids, evidence of interstitial lung disease or active, noninfectious pneumonitis
No history of an immune-related toxicity requiring treatment with corticosteroids during prior PD-1/ PD-L1 inhibitor treatment
Applicable Disease Sites Lung
Participating Institutions UW Hospital and Clinics