Cisplatin-Pemetrexed Compared With Carboplatin-Paclitaxel-Bevacizumab in KRAS Mutated Non-small Cell Lung Cancer

Sponsor
The Netherlands Cancer Institute
Study ID
NCT02743923
Phase
PHASE3
Status
Unknown

Conditions

  • Carcinoma, Non-Small Cell Lung

Eligibility Criteria

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

Interventions

  • carboplatin — DRUG
    AUC 6
  • paclitaxel — DRUG
    200mg/m2
  • Bevacizumab — DRUG
    15 mg/kg
  • Pemetrexed — DRUG
    500 mg/m2
  • cisplatin — DRUG
    75 mg/m2

Study Details

The purpose of this study is to determine whether carboplatin-paclitaxel-bevacizumab results in a prolonged progression free survival compared to cisplatin-pemetrexed as first line treatment in patients with KRAS mutated non-small cell lung cancer.

Key Dates

First listed
Apr 19, 2016
Start date
Apr 30, 2016
Status verified
Dec 2021
Primary completion
Sep 19, 2021
Completion
Apr 30, 2024

Study Design

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

Arms

  • Active Comparator: carboplatin-paclitaxel- bevacizumab
    carboplatin AUC 6, paclitaxel 200 mg/m2, bevacizumab 15 mg/kg all administered intravenously on day 1 every 3 weeks for 4-6 cycles, followed by bevacizumab maintenance every 3 weeks until progression
  • Active Comparator: cisplatin-pemetrexed
    pemetrexed 500 mg/m2 administered intravenously on day 1 and cisplatin 75 mg/m2 administered intravenously on day 1 every 3 weeks for 4-6 cycles, followed by maintenance pemetrexed every 3 weeks until progression.

Primary Outcome Measure

progression free survival [ Time Frame: Every 6 weeks, from date of randomization until the date of progression of disease or of death from any cause, assessed up to 60 months ]

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