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MEDI4736 (Anti PD-L1) Combined With Gefitinib in Subjects With Non-Small Cell Lung Cancer(NSCLC).

NCT02088112 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-04-04

No results posted yet for this study

Summary

This a Phase I, Open-Label, Multicentre Study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of gefitinib in combination with MEDI4736 (anti PD-L1) in Subjects with Non-small cell lung cancer (NSCLC). The study consists of two phases: Escalation phase and an expansion phase to be conducted in locally advanced or metastatic NSCLC subjects

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Gefitinib

Gefitinib QD

DRUG

MEDI4736

MEDI4736 IV Q2W

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Ben Creelan, MD · Moffit Cancer Center

  • Don Gibbons, MD · M.D. Anderson Cancer Center

  • Laura Chow, MD · University of Washington

  • Sang-We Kim, MD · Asan Medical Center

  • Dong-Wan Kim, MD · Seoul National University Hospital

  • Shinitaro Kanda, MD · National Cancer Center

  • Naoyuki Nogami · Shikoku Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-03-24
Primary Completion
2021-03-09
Completion
2021-03-09

Countries

  • United States
  • Japan
  • South Korea

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 NCT02088112 on ClinicalTrials.gov