CompletedPhase 3

An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

United States347 participantsStarted 2009-09

Plain-language summary

This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * histologically or cytologically proven diagnosis of non-small cell lung cancer * positive for the ALK fusion gene (test provided by a central laboratory) * must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug * tumors must be measurable Exclusion Criteria: * prior treatment with PF-02341066 * current treatment in another clinical trial

What they're measuring

Progression-Free Survival (PFS)

Timeframe: Randomization until progressive disease (PD) or initiation of antitumor therapy in the absence of PD or death, assessed every 6 weeks (up to 112 weeks)

Trial details

NCT IDNCT00932893

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-03

Results submitted2013-03-13

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