Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy

Official Title

A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Canakinumab in Combination With Docetaxel Versus Placebo in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancer (NSCLC) Previously Treated With PD-(L)1 Inhibitors and Platinum-based Chemotherapy (CANOPY 2)

Summary:

This phase III study is designed to evaluate the role of IL-1β inhibition in combination with docetaxel in subjects with advanced NSCLC previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy. The randomized III part will be preceded by a safety run-in part in which the recommended dose of the combination of canakinumab and docetaxel will be confirmed.

Trial Description

Primary Outcome:

  • Safety run-in part: Incidence of dose limiting toxicities (DLTs)
  • Randomized part: Overall Survival (OS)
Secondary Outcome:
  • Overall response rate (ORR)
  • Duration of response (DOR)
  • Disease control rate (DCR)
  • Randomized Part only: Progression-Free Survival (PFS)
  • Randomized part only: Time to Response (TTR)
  • Randomized part only: Time to definitive 10 point deterioration symptom scores of pain,cough and dyspnea per QLQ-LC13 questionnaire
  • Randomized part only: Time to definitive deterioration in global health status/QoL, shortness of breath and pain per QLQ-C30 questionnaire
  • Randomized part only: change from baseline in score per the EORTC QLQ C30 questionnaire
  • Randomized part only: change fropm baseline in score as per the EORTC-QLQ LC13 questionnaire
  • Randomized part only: change from baseline in score as per the EQ-5D-5L questionnaire
  • Serum concentration-time profiles of canakinumab
  • Maximum serum concentration (Cmax) of canakimumab
  • Steady-state trough concentrations (Ctrough) of canakinumab
  • Time of maximum serum concentration (Tmax) of canakinumab
  • Plasma concentration-time profiles of docetaxel
  • Maximum plasma concentration (Cmax) of docetaxel
  • Antidrug antibodies (ADA)

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