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

Completed · Phase 1/Phase 2

Conditions studied: Carcinoma, Non-Small Cell Lung

In brief

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).

Key facts

Study ID

NCT00768755

Run by

Pfizer

People needed

180

Starts

2009-01-01

Expected to finish

2012-03-01

Last updated by the study team

2015-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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
• Pfizer Investigational Site — East Providence, Rhode Island, United States
• Pfizer Investigational Site — East Providence, Rhode Island, United States
• Pfizer Investigational Site — Genova, Italy
• Pfizer Investigational Site — Lido Di Camaiore (LU), Italy
• Pfizer Investigational Site — Orbassano (TO), Italy
• Pfizer Investigational Site — Sunto-gun, Shizuoka, Japan
• Pfizer Investigational Site — Lubin, Poland
• Pfizer Investigational Site — Otwock, Poland
• Pfizer Investigational Site — Piła, Poland
• Pfizer Investigational Site — Poznan, Poland
• Pfizer Investigational Site — Poznan, Poland
• Pfizer Investigational Site — Prabuty, Poland
• Pfizer Investigational Site — Warsaw, Poland
• Pfizer Investigational Site — Bacau, Bacău, Romania
• Pfizer Investigational Site — Iași, Iaşi, Romania
• Pfizer Investigational Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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