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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03626545
Phase
PHASE3
Status
Terminated

Conditions

  • Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Canakinumab — DRUG
    Canakinumab, 200 mg, subcutaneous. The initial dose regimen was once every 3 weeks (on Day 1 of each 21-day cycle)
  • Docetaxel — DRUG
    Docetaxel 75mg/m\^2, intravenous, administered on Day 1 of each 21-day cycle
  • Placebo — OTHER
    Placebo, sub-cutaneous, admnistered at the RP3R defined in Part 1-safety run-in.

Study Details

This study was designed to evaluate the role of canakinumab in combination with docetaxel in subjects with advanced non-small cell lung cancer (NSCLC) previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy.

Key Dates

Start date
Jan 23, 2019
Status verified
Aug 2023
Primary completion
Jan 8, 2021
Completion
Dec 20, 2021

Study Design

Enrollment
245 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety run-in part: Canakinumab+docetaxel
    Participants were treated with full doses of docetaxel 75mg/m\^2 intravenous and canakinumab 200 mg subcutaneous on Day 1 of each 21-Day cycle (dose level 1). Subjects were assessed for at least 2 complete cycles of treatment (21 days per cycle; a total of 42 days) for safety evaluation (DLT) to define RP3R. De-escalation to canakinumab 200 mg subcutaneous every 6 weeks + docetaxel 75 mg/m\^2, every 3 weeks could also be considered.
  • Experimental: Randomized part: Canakinumab + docetaxel
    Participants were treated with canakinumab subcutaneous at RP3R and docetaxel at 75 mg/m\^2 every 3 weeks
  • Placebo Comparator: Randomized part: Placebo + docetaxel
    Participants were treated with placebo subcutaneous at RP3R and docetaxel at 75 mg/m\^2 every 3 weeks

Primary Outcome Measure

Safety run-in Part: Percentage of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: During the first 42 days of dosing ]

Locations (6)

FacilityCityStateZIPSite coordinators
Emory Winship Cancer InstituteAtlantaGeorgia30322-
Saint Luke's Hospital/Marion Bloch Neuroscience Institute Dept of RegulatoryKansas CityMissouri64111-
Montefiore Medical Center Albert Einstein College of MedThe BronxNew York10461-
University of Cincinnati Cancer InstituteCincinnatiOhio45267-
MD AndersonHoustonTexas77030-
Huntsman Cancer Institute Univ of Utah .Salt Lake CityUtah84112 0550-

Find similar trials in Atlanta, GA

By research site
Emory Winship Cancer Institute· Atlanta, GASaint Luke's Hospital/Marion Bloch Neuroscience Institute Dept of Regulatory· Kansas City, MOMontefiore Medical Center Albert Einstein College of Med· The Bronx, NYUniversity of Cincinnati Cancer Institute· Cincinnati, OHMD Anderson· Houston, TXHuntsman Cancer Institute Univ of Utah .· Salt Lake City, UT

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