A Study of Erlotinib [Tarceva] as Monotherapy or Intermittent Dosing With Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. (TALISMAN)

Sponsor
Hoffmann-La Roche
Study ID
NCT01204697
Phase
PHASE2
Status
Completed

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • docetaxel — DRUG
    75 mg/m2 intravenously every 3 weeks for 4 cycles
  • erlotinib [Tarceva] — DRUG
    150 mg/day orally, days 2-16 each 3-week cycle for 4 cycles; 150 mg/day orally thereafter
  • erlotinib [Tarceva] — DRUG
    150 mg/day orally as monotherapy

Study Details

This randomized parallel group study will assess the efficacy and safety of erlotinib \[Tarceva\], as monotherapy or intermittent dosing with docetaxel, in second-line setting in former-smoker male patients with advanced or metastatic squamous non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg/day orally) as monotherapy or 4 cycles of docetaxel (75 mg/m2 intravenously every 3 weeks) plus Tarceva (150 mg/day orally, days 2-16 each cycle) followed by Tarceva monotherapy. Anticipated time on study treatment is until disease progression.

Key Dates

First listed
Sep 17, 2010
Start date
Nov 30, 2010
Status verified
Oct 2015
Primary completion
Jul 31, 2014
Completion
Jul 31, 2014

Study Design

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

Arms

  • Experimental: A
  • Experimental: B

Primary Outcome Measure

Percentage of Participants Free From Disease Progression or Death at 6 Months [ Time Frame: Month 6 ]

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