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Randomized Phase 2 Study Of Cisplatin/Pemetrexed With Or Without Axitinib (AG-013736) As First-Line Treatment For Patients With Non-Squamous Non-Small Cell Lung Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Carcinoma, Non-Small Cell Lung

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Trial Information

Randomized Phase 2 Study Of Cisplatin/Pemetrexed With Or Without Axitinib (AG-013736) As First-Line Treatment For Patients With Non-Squamous Non-Small Cell Lung Cancer

Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of adeno-, large cell or
bronchioalveolar non-small cell lung cancer

- Cytologic specimens for diagnosis or for cell type classification must have been
obtained from bronchial brushings or washings or from needle aspiration of a defined
lesion. Sputum cytology alone will not be acceptable for diagnosis or for cell type

- Patients with mixed NSCLC with predominantly squamous cell carcinoma should be
classified as squamous and thus do not qualify for this study.

- Stage IIIB with malignant effusion (with cytologic confirmation of malignant pleural
or pericardial effusion), Stage IV, or recurrent disease after definitive
loco-regional therapy.

- Candidate for primary treatment with cisplatin and pemetrexed

Exclusion Criteria:

- Any histological/cytological evidence of predominantly squamous NSCLC.

- Small cell or carcinoid lung cancer patients are also ineligible.

- NSCLC that cannot be classified as one of the eligible histologies (adenocarcinoma,
large cell or bronchioalveolar).

- Prior systemic therapy for Stage IIIB (with malignant effusion), Stage IV, or
recurrent NSCLC. (Prior treatment with systemic therapy as adjuvant chemotherapy or
in conjunction with radiotherapy for Stage II or III NSCLC is permitted if the last
dose of chemotherapy was completed 12 months or more prior to randomization).

- Prior treatment with a VEGF or VEGFR inhibitor.

Type of Study:


Study Design:

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

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Description:

Time in months from the date of randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus minus the date of randomization plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]); death was determined from AE data (where the outcome was "Death") or from the end of study data.

Outcome Time Frame:

Phase 2 baseline until the date of first documented progression or death due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2009

Completion Date:

March 2012

Related Keywords:

  • Carcinoma, Non-Small Cell Lung
  • non-squamous NSCLC
  • axitinib
  • pemetrexed/cisplatin
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Pfizer Investigational Site Birmingham, Alabama  35205
Pfizer Investigational Site Atlanta, Georgia  30342
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Providence, Rhode Island  02906