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Phase 3, Randomized, Open-Label Study Of The Efficacy And Safety Of Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated East Asian Patients With Non-Squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (ALK) Gene Locus


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
NSCLC (Non-small Cell Lung Cancer)

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Trial Information

Phase 3, Randomized, Open-Label Study Of The Efficacy And Safety Of Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated East Asian Patients With Non-Squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (ALK) Gene Locus


Inclusion Criteria:



- Histologically or cytologically 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 for at least 2 weeks and
are not taking any medications contraindicated in Exclusion Criteria

- 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.

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 CYP3A inducers/inhibitors Concurrent use
of drugs that are CYP3A substrates with narrow therapeutic indices.

- Known HIV infection

- History of extensive disseminated/bilateral or known presence of Grade 3 or 4
interstitial fibrosis or interstitial lung disease, including a history of
pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung
disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior
radiation pneumonitis.

- Other severe acute or chronic medical conditions (including severe gastrointestinal
conditions such as diarrhea or ulcer) or psychiatric conditions, or end-stage renal
disease on hemodialysis, 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS) based on Response Evaluation Criterion in Solid Tumors [RECIST] version 1.1 (documented by independent radiology laboratory)

Outcome Time Frame:

36 months

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

China: Food and Drug Administration

Study ID:

A8081029

NCT ID:

NCT01639001

Start Date:

October 2012

Completion Date:

November 2015

Related Keywords:

  • NSCLC (Non-small Cell Lung Cancer)
  • Crizotinib
  • ALK positive
  • ALK
  • Anaplastic Lymphoma Kinase
  • NSCLC
  • Non-Small Cell Lung Cancer
  • Frontline
  • 1L
  • Previously Untreated
  • East Asian
  • Non-Squamous
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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