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 Non-Small-Cell Lung Cancer

Completed · Phase 2

Conditions studied: Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (Stage IIIB-IV)

In brief

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) .

Key facts

Study ID

NCT02179671

Run by

AstraZeneca

People needed

32

Starts

2014-07-25

Expected to finish

2016-06-11

Last updated by the study team

2019-08-02

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Mixed small cell and NSCLC histology
• Prior exposure to any anti-PD-1 or anti-PD-L1 antibody

Where it is running

• Research Site — Goodyear, Arizona, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Augusta, Georgia, United States
• Research Site — Marietta, Georgia, United States
• Research Site — Ashland, Kentucky, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Mineola, New York, United States
• Research Site — Huntersville, North Carolina, United States
• Research Site — Spokane, Washington, United States
• Research Site — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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