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

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03004105
Phase
PHASE2
Status
Withdrawn

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selumetinib — DRUG
    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.
  • Durvalumab — DRUG
    Safety Run-In, Intermittent Arm, Continuous Arm - Durvalumab 1500 mg by vein on Day 1 of a 28 day cycle.
  • Phone Calls — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 31, 2018
Status verified
Mar 2018
Primary completion
May 31, 2023
Completion
May 31, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intermittent Arm - Selumetinib + Durvalumab
    Intermittent Arm - Participants receive Selumetinib at 75 mg by mouth twice a day for 7 days on and 7 days off, and Durvalumab 1500 mg by vein on Day 1 of a 28 day cycle.
  • Experimental: Safety Run In
    Short safety run-in prior to the start of randomization. Participants on the safety run-in treated with Durvalumab 1500 mg by vein on Day 1 of a 28 day cycle. Safety run-in beginning dose is Selumetinib 50 mg by mouth twice a day on Days 1 through 28 of a 28 day cycle. During the safety run in portion of the trial, enrollment will be open to all comers, regardless of KRAS mutation status.
  • Experimental: Continuous Arm - Selumetinib + Durvalumab
    Continuous Arm - Participants take Selumetinib twice daily on Days 1 to 28 of a 28 day cycle. Dose determined by safety run-in. Participants receive Durvalumab 1500 mg by vein on Day 1 of a 28 day cycle.

Primary Outcome Measure

Progression Free Survival [ Time Frame: 42 months ]

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