Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®.

Sponsor
ETOP IBCSG Partners Foundation
Study ID
NCT01652469
Phase
PHASE3
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • Erlotinib — DRUG
    Erlotinib 150 mg/day p.o. continuously with 21 days cycle.
  • Docetaxel — DRUG
    Docetaxel 75 mg/m2 as an IV infusion every 21 days.

Study Details

Using a laboratory test (VeriStrat), patients with relapsed squamous cell lung cancer are assigned to two strata, VSG (VeriStrat Good) and VSP (VeriStrat Poor). They are then randomized between an EGFR-TK inhibitor (erlotinib) and chemotherapy (Docetaxel). It is hypothesized that the VeriStrat test results are able to predict the benefit of treatment with erlotinib vs docetaxel. This would suggest a significant improvement in progression-free survival for VSG patients when treated with Erlotinib, and no significant improvement in VSP patients who receive the same treatment.

Key Dates

First listed
Jul 30, 2012
Start date
Aug 31, 2012
Status verified
Aug 2022
Primary completion
Dec 31, 2015
Completion
Dec 31, 2015

Study Design

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

Arms

  • Experimental: A: Erlotinib
    Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity.
  • Experimental: B: Docetaxel
    Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity.

Primary Outcome Measure

Progression-free Survival [ Time Frame: The combined run in period, treatment and follow-up for PFS is expected to extend the study duration to a total of 24 months. ]

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