Pembrolizumab in Preventing Lung Cancer in Patients With Stage I-II Non-Small Cell Lung Cancer or High-Risk Pulmonary Nodules, the IMPRINT-Lung Study

Part of paid clinical trials in New York, New York.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03634241
Phase
PHASE2
Status
Completed

Conditions

  • Lung Non-Small Cell Carcinoma
  • Stage I Lung Cancer AJCC v8
  • Stage IA1 Lung Cancer AJCC v8
  • Stage IA2 Lung Cancer AJCC v8
  • Stage IA3 Lung Cancer AJCC v8
  • Stage IB Lung Cancer AJCC v8
  • Stage II Lung Cancer AJCC v8
  • Stage IIA Lung Cancer AJCC v8
  • Stage IIB Lung Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples

Study Details

This phase II trial studies how well pembrolizumab works in preventing lung cancer patients with stage I-II non-small cell lung cancer or high-risk pulmonary nodules. 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.

Key Dates

Start date
Nov 13, 2018
Status verified
Apr 2026
Primary completion
Jan 27, 2026
Completion
Mar 11, 2026

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Pembrolizumab
    Participants receive pembrolizumab IV over 30 minutes on day 1. Treatment repeat every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and collection of blood samples throughout the trial.

Primary Outcome Measure

6-month CT Assessment (Tumor Response Per mRECIST) [ Time Frame: 6 months after treatment initiation ]

Locations (2)

FacilityCityStateZIPSite coordinators
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016-
M D Anderson Cancer CenterHoustonTexas77030-

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By research site
Laura and Isaac Perlmutter Cancer Center at NYU Langone· New York, NYM D Anderson Cancer Center· Houston, TX

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