2nd Line Erlotinib Treatment With (Out) Chemotherapy of Advanced Non Small Cell Lung Cancer (NSCLC)

Sponsor
Dutch Society of Physicians for Pulmonology and Tuberculosis
Study ID
NCT00835471
Phase
PHASE2
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • erlotinib plus docetaxel or pemetrexed — DRUG
    non-squamous carcinoma: pemetrexed 500 mg/m2 on Day 1 plus erlotinib 150 mg/day days 2-16, every 21 days. Pemetrexed will be given for a maximum of 4 cycles. Thereafter erlotinib will be continued continuously until disease progression. squamous carcinoma: Docetaxel 75mg/m2 on Day 1 plus erlotinib 150mg/day days 2-16, every 21 days. Docetaxel will be given for a maximum of 4 cycles. Thereafter erlotinib will be continued continuously until disease progression.
  • erlotinib — DRUG
    erlotinib 150 mg/day continuously until disease progression

Study Details

The purpose of this study is to assess if the combination of erlotinib and chemotherapy (docetaxel in case of squamous cell NSCLC or pemetrexed in case of other histological types) is superior to erlotinib alone and has acceptable tolerability and safety in the 2nd line treatment of patients with advanced/metastatic non-small cell lung cancer (NSCLC).

Key Dates

First listed
Feb 3, 2009
Start date
Mar 31, 2009
Status verified
Sep 2020
Primary completion
Jun 30, 2014
Completion
Jun 30, 2019

Study Design

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

Arms

  • Experimental: 1
    Erlotinib plus docetaxel (squamous cell NSCLC) or pemetrexed (non-squamous cell NSCLC)
  • Active Comparator: 2
    Erlotinib

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From randomisation to date of first progression or date of death, assessed up to 36 months ]

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