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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 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
Open (Enrolling)
Non Squamous Lung Cancer

Thank you

Trial Information

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

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]

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Time Frame:

35 months

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2011

Completion Date:

November 2013

Related Keywords:

  • Non Squamous Lung Cancer
  • open label
  • randomized Phase 3
  • first line treatment
  • non squamous lung cancer
  • ALK translocation event positive
  • Lung Neoplasms



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