Erlotinib Treatment Beyond Progression in EGFR Mutant NSCLC

Sponsor
Finnish Lung Cancer Group
Study ID
NCT02064491
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to determine whether continuing erlotinib beyond disease progression in combination with chemotherapy is beneficial for NSCLC patients who have EGFR mutant disease or who have responded to EGFR TKI.

Key Dates

First listed
Feb 17, 2014
Start date
Feb 28, 2014
Status verified
Jun 2017
Primary completion
Dec 31, 2016
Completion
May 31, 2017

Study Design

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

Arms

  • Experimental: Erlotinib and Chemotherapy
    Intercalated erlotinib in combination with chemotherapy for four to six cycles followed by continuous erlotinib maintenance
  • Active Comparator: Chemotherapy
    Chemotherapy for four to six cycles

Primary Outcome Measure

Progression-free survival of the whole study population and in the strata 1-2 [ Time Frame: An expected average of 36 weeks after last subject enrolled into our study ]

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