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A Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations


Title An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs Erlotinib or Gefitinib in First-line Treatment of Patients with Stage IIIB/IV Non-small Cell Lung Cancer Tumors with EGFR Activating Mutations SOLAR Study
Therapeutic Area Lung Cancer, Non Small Cell Lung Cancer
Principal Investigator Lori Pai, MD
Min Age 18 Years
Gender Both
Contact Madeleine Arthur
617-636-2616
More Information https://clinicaltrials.gov/ct2/show/NCT02588261

Overview

The purpose of the study is to collect information to determine if an investigational drug called ASP8273 is effective, safe and comparable to the treatments erlotinib or gefitinib that are already approved in the US, Europe and Asia, respectively, for patients with your type of NSCLC.

Study Details

Inclusion Criteria

  • People with newly diagnosed or recurrent non-small cell lung cancer
  • People with EGFR mutations
  • People with otherwise normal organ function

Exclusion Criteria

  • No pregnant or nursing women
  • No prior treatment with drugs targeting EGFR (e.g. afatinib or dacomitinib)
  • No brain or spine metastases that require active treatment or other complicating diseases or disorders

Study Requirements

Subjects will come to the hospital for screening tests including blood tests (~2 tablespoons), an ECG, a CT or MRI, and questionnaires. A sample of their tumor tissue will be tested for EGFR mutations. If there is no available tumor tissue, a biopsy will be performed to obtain a tumor sample. Subjects will receive the investigation drug (ASP8273), erlotinib, or gefitinib. Subjects will receive study drug in 28 day cycles. They will come to the hospital for clinic visits twice during the first cycle, once during cycles 2-6, and every other cycle thereafter. Clinic visits include physical exams, blood tests to monitor health (~1 tablespoon), blood collection for research (1-2 tablespoons) urine tests to monitor health, ECGs, and questionnaires. Subjects will have CT scans every other month. Subjects can continue to receive study drug until their disease gets worse, they experience unacceptable side effects, they decide to, or the sponsor stops the study.