Overview

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