Afatinib vs Erlotinib as 2nd TKI After Failure to 1st TKI and Chemotherapy for Metastatic NSCLC

Sponsor
The University of Hong Kong
Study ID
NCT02625168
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Afatinib — DRUG
    Afatinib from study recruitment until disease progression, intolerable side effects as judged by investigators or patient withdrawal
  • Erlotinib — DRUG
    Erlotinib from study recruitment until disease progression, intolerable side effects as judged by investigators or patient withdrawal

Study Details

The investigators prospectively evaluated in this study the efficacy and safety profiles of afatinib as 3rd or 4th line treatment after prior failure to systemic chemotherapy and first-generation EGFR-TKI under a Boehringer Ingelheim sponsored Compassionate Use Program (CUP), with comparison of our historical cohort who received erlotinib after previous failure to systemic chemotherapy and first-generation EGFR-TKI.

Key Dates

First listed
Dec 9, 2015
Start date
Jan 31, 2013
Status verified
Dec 2015
Primary completion
Sep 30, 2014
Completion
Dec 31, 2014

Study Design

Enrollment
25 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Afatinib
    Afatinib 30 or 40 or 50mg daily orally after study recruitment until radiologically documented disease progression, intolerable side effects as judged by investigators or patient withdrawal.
  • Experimental: Erlotinib
    Erlotinib 150mg daily until radiologically documented disease progression, intolerable side effects as judged by investigators or patient withdrawal.

Primary Outcome Measure

Progression-free survival [ Time Frame: From date of start of study medication until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]

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