CompletedPhase 1 / Phase 2NCT00768755
Official study title

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

Study summary

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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedaxitinib and axitinib

Plus 3 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 28, 2015 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?52 U.S. locations

Locations may change over time.

Who runs it?Pfizer

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Pfizer
Interventions being studied
Drug: axitinib; Drug: axitinib; Drug: chemotherapy; Drug: axitinib; Drug: chemotherapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Pfizer Investigational SiteHuntsville, Alabama
  • Pfizer Investigational SiteAtlanta, Georgia
  • Pfizer Investigational SiteDecatur, Georgia
  • Pfizer Investigational SiteMacon, Georgia
  • Pfizer Investigational SiteMarietta, Georgia
  • Pfizer Investigational SiteSandy Springs, Georgia
  • Pfizer Investigational SiteBloomington, Illinois
  • Pfizer Investigational SitePeoria, Illinois
  • Pfizer Investigational SiteHershey, Pennsylvania
  • Pfizer Investigational SiteWest Reading, Pennsylvania
  • Pfizer Investigational SiteEast Providence, Rhode Island
  • Pfizer Investigational SiteEast Providence, Rhode Island

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 28, 2015. Always confirm current availability with the study team.

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