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Protocol No. UW17046

Principal Investigator Leal, Ticiana

Phase II

Age Group Adult

Scope National

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 physicianÂ’s choice chemotherapy with either Docetaxel, Premetrexed or Gemcitabine

Description Single arm Phase II, using Pembrolizumab plus standard of care per MD decision.

Key Eligibility
  • 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

    Status Open

    Participating Institutions UW Hospital and Clinics