Evaluation Of The Efficacy Of The Combination Of Axitinib With Pemetrexed And Cisplatin In The Treatment Of Non-Squamous Non-Small Cell Lung Cancer

Pfizer180 enrolled

Overview

AG-013736 (axitinib) in combination with cisplatin and pemetrexed will be evaluated as first-line treatment of patients with locally advanced, recurrent, or metastatic non-squamous, non small cell lung cancer (NSCLC).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Carcinoma, Non-Small Cell Lung

Interventions

axitinibDRUG

5mg BID po up to max 10mg BID po

axitinibDRUG

5mg BID po up to max 10mg BID po paused for 3 days before each cycle of concomitant chemotherapy

chemotherapyDRUG

Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 classification. * 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.

Locations (52)

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

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.

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

Secondary Outcomes

Overall Survival (OS)

Time in months from the date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death).

Time frame: Baseline until death or collected bimonthly following discontinuation of study treatment until at least 1 year after randomization of the last participant

Percentage of Participants With Objective Response (OR)

Percentage of participants with OR based assessment of confirmed complete response (CR)/confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors(RECIST).Confirmed responses: those persist on repeat imaging study at least 4 weeks after initial documentation of response.CR: disappearance of all lesions (target/non target) and no appearance of new lesions.PR: those with at least 30 % decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions,without progression of non target lesions and no appearance of new lesions.

Time frame: Phase 2 baseline until the date of first documented progression or discontinuation from the study due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Huntsville, Alabama, United States

Pfizer Investigational Site

Atlanta, Georgia, United States

Pfizer Investigational Site

Decatur, Georgia, United States

Pfizer Investigational Site

Macon, Georgia, United States

Pfizer Investigational Site

Marietta, Georgia, United States

Pfizer Investigational Site

Sandy Springs, Georgia, United States

Pfizer Investigational Site

Bloomington, Illinois, United States

Pfizer Investigational Site

Peoria, Illinois, United States

Pfizer Investigational Site

Hershey, Pennsylvania, United States

Pfizer Investigational Site

West Reading, Pennsylvania, United States

...and 42 more locations