Phase 2
N=1,066
An Investigational Drug, PF-02341066, Is Being Studied 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: NCT00932451 ↗Enrolled (actual)
1,066
Serious AEs
50.6%
Results posted
Jun 2016
Primary outcome: Primary: Objective Response Rate — 54.1; 40.5 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PF-02341066 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate |
54.1; 40.5 | — |
| PRIMARY Percentage of Participants With Adverse Events |
50.6; 65.6; 22.7; 11.5; 40.2; 1.6 | — |
| SECONDARY Duration of Response (DR) |
11.8; 9.5 | — |
| SECONDARY Time to Tumor Response (TTR) |
6.1; 6.3 | — |
| SECONDARY Disease Control Rate (DCR) |
81.7; 70.8; 69.6; 61.4 | — |
| SECONDARY Progression Free Survival (PFS) |
8.4; 6.9 | — |
| SECONDARY Overall Survival (OS) |
21.8; 16.9 | — |
| SECONDARY Probability of Survival |
81.7; 77.5; 66.5; 62.4 | — |
| SECONDARY Plasma Concentrations of Crizotinib (PF-02341066) and Its Metabolite PF-06260182 |
1.95; 0.00601; 279; 76.2; 297; 80.8 | — |
| SECONDARY Molecular Profiling (ALK Status) Descriptive Statistics for ALK Percentage of Positive Cells by Central Laboratory Test (SA [ALK Positive by IUO] Population) |
60.0 | — |
| SECONDARY Genotypes of Alleles Possibly Associated With Adverse Hepatic Drug Reactions (Pharmacogenomic Evaluable Population) |
20.3; 20.0; 17.6; 16.5; 20.3; 20.0 | — |
| SECONDARY QTc Prolongation in Participants |
89.8; 7.7; 1.0; 1.5; 74.3; 21.2 | — |
| SECONDARY Mean Change From Baseline in QLQ-C30 Global Quality of Life Scores. |
7.9; 10.6; 12.2; 11.5; 11.9; 12.3 | — |
| SECONDARY Mean Change From Baseline of EORTC QLQ-C30 Functional and Symptom Scale Scores |
4.3; 6.6; 8.2; 8.8; 9.5; 10.0 | — |
| SECONDARY Mean Change From Baseline of QLQ-LC13 Scale Scores |
-9.1; -10.2; -11.6; -12.2; -10.5; -11.9 | — |
| SECONDARY Percentage of Participants With Visual Symptom Assessment Questionnaire (VSAQ-ALK) |
64.5; 35.5; 56.5; 43.5; 52.3; 47.7 | — |
| SECONDARY Patient Reported Outcomes (PROs) of Health-related Quality of Life (HRQoL): Mean Change From Baseline of EQ-5D Visual Analog Score (VAS) Scale |
5.72; 8.57; 10.01; 10.38; 10.17; 10.17 | — |
Summary
This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.
Eligibility Criteria
Inclusion Criteria
- histologically or cytologically proven diagnosis of non-small cell lung cancer
- positive for the ALK fusion gene (test provided by either a central laboratory. Local laboratory may be used for certain cases)
- may have received pemetrexed or docetaxel from previous Phase 3 trial (A8081007) and discontinued treatment due to Response Evaluation Criterion in Solid Tumors (RECIST)-defined progression. or, once the primary endpoint of Study A8081007 has been analyzed and the results made available, at any time without RECIST-defined progression.
- Tumors can be measurable or non measurable
Exclusion Criteria
- prior treatment with PF-02341066
- received no prior systemic treatment, chemotherapy or EGFR tyrosine kinase inhibitor, for advanced non-small cell lung cancer
- current enrollment in another therapeutic clinical trial
Data sourced from ClinicalTrials.gov (NCT00932451). 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.