Loading clinical trials...

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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase IIa, Open-Label, Multi-Center, Multi-Cohort, 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 (Stage IIIB-IV)

NCT02179671•AstraZeneca

View on ClinicalTrials.gov

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) .

Detailed Description

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.

Eligibility

Age

18 - 130 years

Sex

ALL

Healthy Volunteers

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

Locations (10)

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

Key Dates

Start Date

July 25, 2014

Primary Completion Date

June 11, 2016

Completion Date

June 11, 2016

Last Updated

August 2, 2019

Enrollment

ACTUAL participants

Conditions

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

Interventions

Gefitinib

DRUG

AZD9291

DRUG

Selumetinib+Docetaxel

DRUG

Tremelimumab

DRUG