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

Pfizer

Status and phase: Completed; Phase 2; Phase 1

Conditions: Carcinoma, Non-Small Cell Lung

Treatments: Drug: chemotherapy; Drug: axitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00768755

A4061039

Details and patient eligibility

About

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).

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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180 participants in 5 patient groups

I

Experimental group

Description:

Axitinib (continuous) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance

Treatment:

Drug: axitinib

Drug: axitinib

Drug: axitinib

II

Experimental group

Description:

Axitinib (modified) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance

Treatment:

Drug: axitinib

Drug: axitinib

Drug: axitinib

III

Active Comparator group

Description:

pemetrexed and cisplatin

Treatment:

Drug: chemotherapy

Drug: chemotherapy

IV

Experimental group

Description:

Axitinib interrupted before each chemo cycle (Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance

Treatment:

Drug: axitinib

Drug: axitinib

Drug: axitinib

V

Active Comparator group

Description:

pemetrexed and cisplatin

Treatment:

Drug: chemotherapy

Drug: chemotherapy