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

Purpose

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.

Condition

  • Non-Small-Cell Lung

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histologically confirmed advanced (stage IIIB) or metastatic NSCLC.
  • Subject has received one prior platinum-based chemotherapy and one prior PD-(L)1 inhibitor therapy for locally advanced or metastatic disease.
  • Subject with ECOG performance status (PS) of 0 or 1.
  • Subject with at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 in solid tumors criteria.

Exclusion Criteria

  • Subject who previously received docetaxel, canakinumab (or another IL-1β inhibitor), or any systemic therapy for their locally advanced or metastatic NSCLC other than one platinum-based chemotherapy and one prior PD-(L)1 inhibitor.
  • Subject with EGFRor ALK positive tumor.
  • History of severe hypersensitivity reaction to monoclonal antibodies, taxanes or excipients of docetaxel or canakinumab.

Other protocol-defined inclusion/exclusion may apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Canakinumab
Blinded Canakinumab administered at the recommended Phase III regimen (defined in the safety run-in part). Canakinumab will be given in combination with docetaxel (standard of care)
  • Drug: Canakinumab
    Canakinumab, subcutaneous, administred at the recommended Phase III regimen (defined in the safety run-in part)
    Other names:
    • ACZ885
  • Drug: Docetaxel
    Standard of care: docetaxel 75mg/m2, intravenous, every 3 weeks
Placebo Comparator
Placebo
Matching placebo, administered at the recommended Phase III regimen (defined in the safety run-in part), in combination with docetaxel (standard of care)
  • Drug: Docetaxel
    Standard of care: docetaxel 75mg/m2, intravenous, every 3 weeks
  • Other: Placebo
    Placebo, sub-cutaneous, administered at the recommended Phase III regimen (defined in the safety run-in part).
    Other names:
    • Placebo control

Recruiting Locations

Montefiore Medical Center Albert Einstein College of Med
Bronx, New York 10461
Contact:
Inuska Rodriquez
inurodri@montefiore.org

More Details

NCT ID
NCT03626545
Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com