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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-25

Study Completion Date

2016-06-11

Brief Summary

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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) .

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Detailed Description

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This is a multi-arm, multi-cohort, Phase IIa, open-label study of selected small molecules (gefitinib, AZD9291, or selumetinib + docetaxel) or 1st IMT (hereafter referred to as IMT-A; tremelimumab) followed by sequential switch to a 2nd IMT (hereafter referred to as IMT-B; MEDI4736) in locally advanced or metastatic NSCLC (Stage IIIB-IV). Patients will be enrolled concurrently into multiple cohorts.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

Tremelimumab every 4 weeks followed by MEDI4736

Interventions

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Gefitinib

Gefitinib once daily followed by MEDI4736

Intervention Type DRUG

AZD9291

AZD9291 once daily followed by MEDI4736

Intervention Type DRUG

Selumetinib+Docetaxel

Selumetinib twice daily + docetaxel, followed by MEDI4736

Intervention Type DRUG

Tremelimumab

Tremelimumab every 4 weeks followed by MEDI4736

Intervention Type DRUG

Eligibility Criteria

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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