Trametinib and Pembrolizumab in Treating Patients With Recurrent Non-small Cell Lung Cancer That Is Metastatic, Unresectable, or Locally Advanced

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03225664
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Lung Non-Small Cell Carcinoma
  • Recurrent Lung Non-Small Cell Carcinoma
  • Stage III Lung Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Stage IVB Lung Cancer AJCC v8
  • Unresectable Lung Non-Small Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Pharmacokinetic Study — OTHER
    Correlative studies
  • Trametinib — DRUG
    Given PO

Study Details

This phase Ib/II trial studies the side effects and best dose of trametinib when given together with pembrolizumab and to see how well they work in treating patients with non-small cell lung cancer that has come back and spread to other places in the body, cannot be removed by surgery, or spread to nearby tissues or lymph nodes. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving trametinib and pembrolizumab may work better in treating patients with non-small cell lung cancer.

Key Dates

Start date
Feb 3, 2018
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (trametinib, pembrolizumab)
    Patients receive trametinib PO QD 14 days prior to cycle 1 and days 1-10 of each course (10 days on, 11 days off). Beginning in cycle 2, participants also receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall objective response rate evaluated according to modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1 and immune related [ir]RECIST) [ Time Frame: At 6 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06520-
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in New Haven, CT

By research site
Yale University· New Haven, CTM D Anderson Cancer Center· Houston, TX

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