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MEDI4736 With Selumetinib for KRAS Mutant Non-Small Cell Lung Cancer (NSCLC)

NCT03004105 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-03-16

No results posted yet for this study

Summary

The goal of this clinical research study is to learn if MEDI4736 given in combination with selumetinib can help to control advanced lung cancer.

The safety of this drug combination will also be studied.

Conditions

  • Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma
  • Advanced Lung Cancer
  • Recurrent Nonsmall Cell Lung Cancer

Interventions

DRUG

Selumetinib

Safety Run-In - Beginning dose is Selumetinib 50 mg by mouth twice a day on Days 1 through 28 of a 28 day cycle Intermittent Arm - Participants receive Selumetinib at 75 mg by mouth twice a day for 7 days on and 7 days off. Continuous Arm - Participants take Selumetinib twice daily on Days 1 to 28 of a 28 day cycle. Dose determined by safety run-in.

DRUG

Durvalumab

Safety Run-In, Intermittent Arm, Continuous Arm - Durvalumab 1500 mg by vein on Day 1 of a 28 day cycle.

BEHAVIORAL

Phone Calls

About every 6 months, participant called by a member of the study staff to ask how participant is doing and if participant has started any new treatments outside of the study. These calls should last about 10 minutes each time.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • MedImmune LLC

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2023-05-31
Completion
2024-05-31
FDA Drug
Yes

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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 NCT03004105 on ClinicalTrials.gov