Overview

This trial is active, not recruiting.

Condition non squamous lung cancer
Treatments treatment
Phase phase 3
Sponsor Pfizer
Start date January 2011
End date November 2013
Trial size 343 participants
Trial identifier NCT01154140, 2010-021336-33, A8081014, XALCORI

Summary

This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
treatment
crizotinib 250mg orally continuous twice daily dosing
(Active Comparator)
treatment
pemetrexed 500mg/m2 IV day 1 plus cisplatin 75mg/m2 IV day 1 every 21 days OR pemetrexed 500mg/m2 IV day 1 plus carboplatin AUC 5 or 6 day 1 every 21 days investigator's choice

Primary Outcomes

Measure
Progression-Free Survival (PFS) Based on Independent Radiology Review (IRR) by Treatment Arm
time frame: Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)

Secondary Outcomes

Measure
Overall Survival (OS)
time frame: From randomization to death or last date known alive for those not known to have died (up to 35 months)
OS Probability at Months 12 and 18
time frame: Months 12 and 18
Objective Response Rate - Percentage of Participants With Objective Response as Assessed by IRR
time frame: Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Duration of Response (DR) Based on IRR
time frame: From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months).
Time to Tumor Response (TTR) Based on IRR
time frame: Randomization to first documentation of objective tumor response (up to 35 months)
Percentage of Participants With Disease Control at Week 12 Based on IRR
time frame: From randomization to Week 12
Time to Progression (TTP) Based on IRR
time frame: Randomization to objective progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Time to Intracranial Progression (IC-TTP) Based on IRR
time frame: Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Time to Extracranial Progression (EC-TTP) Based on IRR
time frame: Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Percentage of Participants With Treatment-emergent Adverse Events (AEs; All Causalities)
time frame: From the first dose of study medication until 28 days after the last dose of study medication. However all AEs entered in the database from the treatment start were included in AE analyses
Percentage of Participants With Treatment-emergent AEs (Treatment Related)
time frame: From the first dose of study medication until 28 days after the last dose of study medication. However all AEs entered in the database from the treatment start were included in AE analyses.
Plasma Predose Concentration (Trough Concentration [Ctrough]) of Crizotinib and Its Metabolite
time frame: Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 5 Day 1
Percentage of Participants for Each Anaplastic Lymphoma Kinase (ALK) Gene Fusion Variants
time frame: Screening
ORR Between ALK Variant Groups Based on IRR
time frame: Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Time to Deterioration (TTD) in Pain in Chest, Dyspnea, or Cough
time frame: From Baseline to deterioration while on study treatment
Change From Baseline in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
time frame: Cycle 1 day 1 to end of treatment or withdrawal or crossover
Change From Baseline Scores in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30
time frame: Cycle 1 day 1 to end of treatment or withdrawal or crossover
Change From Baseline in Lung Cancer Symptom Scores as Assessed by the EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13)
time frame: Cycle 1 day 1 to end of treatment or withdrawal or crossover
Change From Baseline in General Health Status as Assessed by EuroQol 5D (EQ-5D)- Visual Analog Scale (VAS)
time frame: From Baseline up to treatment withdrawal or crossover
Percentage of Participants With Hospital Admissions-Healthcare Resource Utilization (HCRU)
time frame: From 28 days prior to the start of study treatment and up to 28 days post the last dose of study treatment

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung - Positive for translocation or inversion events involving the ALK gene locus - No prior systemic treatment for locally advanced or metastatic disease; Patients with brain metastases only if treated and neurologically stable with no ongoing requirement for corticosteroids - Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome [PRO] measures. - 18 years of age or older with the exception of India which has an upper age limit of 65 years old Exclusion Criteria: - Current treatment on another therapeutic clinical trial. - Prior therapy directly targeting ALK. - Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. - - Appropriate treatment with anticoagulants is permitted. - Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec. - Pregnancy or breastfeeding. - Use of drugs or foods that are known potent CYP3A4 inducers/inhibitors Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices. - Known HIV infection - Known interstitial lung disease or interstitial fibrosis - Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study

Additional Information

Official title Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated Patients With Non-squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Pfizer.