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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

NCT02179671 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-08-02

Study results available
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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) .

Conditions

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

Interventions

DRUG

Gefitinib

Gefitinib once daily followed by MEDI4736

DRUG

AZD9291

AZD9291 once daily followed by MEDI4736

DRUG

Selumetinib+Docetaxel

Selumetinib twice daily + docetaxel, followed by MEDI4736

DRUG

Tremelimumab

Tremelimumab every 4 weeks followed by MEDI4736

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Samir N. Khleif, MD · International Coordinating Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-25
Primary Completion
2016-06-11
Completion
2016-06-11

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02179671 on ClinicalTrials.gov