PDR001 in Combination With Platinum-doublet Chemotherapy and Other Immunology Agents in PD-L1 Unselected, Metastatic NSCLC Patients

Official Title

Phase Ib, Multicentre, Open Label Study of PDR001 in Combination With Platinum Doublet Chemotherapy and Other Immunooncology Agents in PD-L1 Unselected, Metastatic NSCLS Patients (ElevatION:NSCLC-101 Trial)

Summary:

The primary purpose of this study is to establish the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of PDR001 when administered in combination with platinum-doublet chemotherapy and other immunooncology agent(s) in treatment naive patients with PD-L1 unselected, advanced NSCLC, and to estimate the preliminary anti-tumour activity in this patient population.

Trial Description

Primary Outcome:

  • Dose Limiting Toxicities (DLTs) during the first 6 weeks of therapy
  • Overall response rate (ORR)
Secondary Outcome:
  • Progression Free Survival (PFS) per Investigator
  • Disease Control Rate (DCR) per Investigator
  • Duration of Response (DOR) per Investigator
  • Time to Response (TTR) per Investigator
  • Overall survival (OS)
  • Peak Serum Concentration (Cmax) (PDR001)
  • Peak Plasma Concentration (Cmax) (chemotherapy)
  • Antidrug antibodies (ADA) prevalence at baseline
  • ADA incidence on treatment
  • Trough Serum Concentration (Cmin) (PDR001)
  • Trough PlasmaConcentration (Cmin) (chemotherapy)
  • Progression Free Survival (PDF) by blinded independend review commitee (BIRC)
  • Overall response rate (ORR) by blinded independend review commitee (BIRC)
  • Disease control rate (DCR) by blinded independend review commitee (BIRC)
  • Duration of Response (DOR) by blinded independend review commitee (BIRC)
  • Time to Response (TTR) by blinded independend review commitee (BIRC)
  • Incidence of AEs (CTCAE v4.03)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society