A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT01667562
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Erlotinib — DRUG
    Daily oral doses administered until disease progression or unacceptable toxicity or death.

Study Details

This open-label, multi-center study will evaluate the progression-free survival and safety of erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR). Participants will receive daily oral doses of erlotinib until disease progression or unacceptable toxicity.

Key Dates

First listed
Aug 17, 2012
Start date
Jan 20, 2012
Status verified
Dec 2019
Primary completion
Sep 7, 2017
Completion
Sep 7, 2017

Study Design

Enrollment
375 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib
    Erlotinib will be administered as a single daily oral dose of 150 milligrams until disease progression, death or unacceptable toxicity.
  • No Intervention: Diagnostic Phase
    Participants with advanced or metastatic NSCLC were tested for EGFR mutations. Participants who did not have an EGFR mutation were excluded from the study.

Primary Outcome Measure

Progression-Free Survival as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1) [ Time Frame: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months) ]

Related Studies