Selumetinib in Patients Receiving Pemetrexed and Platinum-based Chemotherapy in Advanced or Metastatic KRAS Wildtype or Unknown Non-Squamous NSCLC

Sponsor
Canadian Cancer Trials Group
Study ID
NCT02337530
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Selumetinib — DRUG
  • Pemetrexed — DRUG
  • Cisplatin — DRUG
  • Carboplatin — DRUG

Study Details

The purpose of this study is to find out what effects a new drug, selumetinib, has on lung cancer when receiving standard chemotherapy with pemetrexed and platinum-based chemotherapy.

Key Dates

Start date
May 26, 2015
Status verified
Mar 2024
Primary completion
Oct 31, 2017
Completion
Jun 18, 2019

Study Design

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

Arms

  • Active Comparator: Arm A
    Selumetinib: 75mg/ bid PO given on days 2-19 Pemetrexed: 500mg/m\^2 \& Cisplatin or Carboplatin\*: AUC6: 75mg/m\^2 given on day 1 Schedule = q 21 days \*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG
  • Active Comparator: Arm B
    Selumetinib: 75mg/ bid PO given on days 1-21 (continuous) Pemetrexed: 500mg/m\^2 \& Cisplatin\*: 75mg/m\^2 or carboplatin AUC 6 given on day 1 Schedule = q 21 days \*\*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG
  • Active Comparator: Arm C
    Selumetinib: NOT GIVEN Pemetrexed: 500mg/m\^2 \& Cisplatin\*: 75mg/m\^2 or carboplatin AUC6 given on day 1 Schedule = q 21 days \*Must be specified at time of randomization. Patients who start on treatment with cisplatin may switch to carboplatin only after discussion with CCTG

Primary Outcome Measure

Objective Response Rate [ Time Frame: 2 years and 5 months. ]

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