Phase 3
N=347
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
Carcinoma, Non-Small-Cell Lung
Bottom Line
View on ClinicalTrials.gov: NCT00932893 ↗Enrolled (actual)
347
Serious AEs
35.6%
Results posted
Jun 2013
Primary outcome: Primary: Progression-Free Survival (PFS) — 7.7; 3.0 months — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PF-02341066 (Drug); Pemetrexed (Drug); Docetaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
7.7; 3.0 | <0.0001 sig |
| SECONDARY Overall Survival (OS) |
21.7; 21.9 | 0.1145 |
| SECONDARY Overall Survival Probability at Months 6 and 12 |
86.6; 83.8; 70.4; 66.7 | — |
| SECONDARY Percentage of Participants With Objective Response (OR) |
65.3; 19.5 | <0.0001 sig |
| SECONDARY Percentage of Participants With Disease Control at Week 6 |
81.5; 55.2 | <0.0001 sig |
| SECONDARY Percentage of Participants With Disease Control at Week 12 |
64.2; 38.5 | <0.0001 sig |
| SECONDARY Duration of Response (DR) |
32.1; 24.4 | — |
| SECONDARY Time to Tumor Response (TTR) |
6.3; 12.6 | — |
| SECONDARY Plasma Concentration of Crizotinib |
NA; 298; 293; 306; 291 | — |
| SECONDARY Number of Participants With Categorical Maximum QTcF for Crizotinib |
137; 9; 1; 8 | — |
| SECONDARY Plasma Concentration of Soluble c-Met Ectodomain and Hepatocyte Growth Factor Scatter Proteins |
1428.3; 1683.0; 1751.8 | — |
| SECONDARY Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, and Cough |
4.5; 1.4 | <0.0001 sig |
| SECONDARY European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) |
57.2; 58.1; 64.5; 58.1; 65.2; 59.4 | — |
| SECONDARY European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Supplement Module for Lung Cancer (EORTC QLQ-LC13) |
27.2; 26.9; 17.6; 28.6; 17.9; 28.0 | — |
| SECONDARY European Quality of Life - 5 Dimensional (EQ-5D) Visual Analog Scale (VAS) |
64.09; 66.76; 69.19; 66.33; 73.13; 65.84 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00932893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.