Immune-Modulated Study of Selected Small Molecules (Gefitinib, AZD9291, or Selumetinib + Docetaxel) or a 1st Immune-Mediated Therapy (IMT; Tremelimumab) With a Sequential Switch to a 2nd IMT (MEDI4736) in Patients With Locally Advanced or Metastatic

• Status: Completed
• Trial end date: 2016-06-11
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective: To assess the efficacy of various sequences of either a small molecule or an IMT (IMT-A) followed by a IMT-B (MEDI4736) .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Quintiles, Inc.
• Treatments: Antibodies, Monoclonal; Docetaxel; Gefitinib; Osimertinib; Tremelimumab

Criteria

Inclusion Criteria:

• Provision of archived tumor tissue sample and mandatory tissue biopsy

• Patients must have either histologically or cytologically documented NSCLC who present with locally advanced or metastatic stage IIIB-IV disease

• Life expectancy ≥12 weeks

• Patients must have measurable disease and at least 1 lesion not previously irradiated

• World Health Organization (WHO) performance status of 0 or 1

Exclusion Criteria:

• Mixed small cell and NSCLC histology

• Prior exposure to any anti-PD-1 or anti-PD-L1 antibody