Afatinib and Selumetinib in Advanced KRAS Mutant and PIK3CA Wildtype Non-small Cell Lung Cancer

Sponsor
The Netherlands Cancer Institute
Study ID
NCT02450656
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Afatinib — DRUG
    Tablet
  • Selumetinib — DRUG
    Capsule
  • Docetaxel — DRUG

Study Details

This is a multi-center open-label proof-of-concept study consisting of two parts: PART A - a phase I dose-finding study (3 + 3 classical design) evaluating the RP2D of afatinib in combination with selumetinib in KRASm NSCLC; and PART B - a randomized phase II study investigating the progression free survival and safety of selumetinib/afatinib combination therapy compared to standard of care chemotherapy in KRASm NSCLC.

Key Dates

Start date
Jun 30, 2015
Status verified
Aug 2018
Primary completion
May 31, 2019
Completion
Dec 31, 2019

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Afatinib plus selumetinib
    Combination of afatinib and selumetinib at the optimal dose and regimen as determined in the phase I part of this study
  • Active Comparator: Control
    Standard-of-care second line treatment for non small cell lung cancer (docetaxel)

Primary Outcome Measure

Dose Limiting Toxicities (Phase I) [ Time Frame: Cycle 1 (4 weeks) ]

Central Contacts

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