Progression Free Survival (PFS) Using Erlotinib for Non-Small-Cell Lung Cancer (NSCLC) in Chinese Population

Sponsor
Hoffmann-La Roche
Study ID
NCT02000531
Phase
PHASE4
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • Erlotinib — DRUG
    150 mg oral dose of erlotinib given once daily
  • Chemotherapy — DRUG
    Cisplatin (75 mg/m\^2 intravenously \[IV\]) on Day 1 and gemcitabine (1250 mg/m\^2 IV) on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first)

Study Details

This trial is an extension to ENSURE, a study of erlotinib versus gemcitabine/cisplatin combination chemotherapy as the first-line treatment for patients with non-small-cell lung cancer (NSCLC) with mutations in the tyrosine kinase domain of EGFR. This study is designed to examine the efficacy of erlotinib versus gemcitabine/cisplatin as a second-line treatment in NSCLC patients from the ENSURE trial (NCT01342965). Patients previously treated with gemcitabine/cisplatin will be given erlotinib daily until disease progression or unacceptable toxicity occurs. Patients previously treated with erlotinib will be given cisplatin on Day 1 and gemcitabine on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first).

Key Dates

First listed
Dec 4, 2013
Start date
Jan 31, 2014
Status verified
Dec 2015
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

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

Arms

  • Experimental: Erlotinib-Chemotherapy
    Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
  • Active Comparator: Chemotherapy-Erlotinib
    Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment

Primary Outcome Measure

Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events [ Time Frame: within 3 years, 9 months (data cut-off December 2014) ]

Related Studies