RECRUITING

Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)

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Conditions

Lung Neoplasm MalignantProgrammed Cell Death-1 (PD1, PD-1)Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main goals are after treatment given before surgery, to measure the number of people who have no signs of cancer cells in tumors and lymph nodes removed during surgery; and to learn about whether the cancer gets smaller or goes away by measuring the number of people with a certain number of living cancer cells in the tumor removed during surgery.

Official Title

KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)

Quick Facts

Study Start:2025-03-14
Study Completion:2032-02-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06788912

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC)
  2. * Able to undergo protocol therapy, including necessary surgery
  3. * Confirmation that epidermal growth factor receptor (EGFR) -directed therapy is not indicated as primary therapy
  4. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 10 days before initiation of study intervention.
  5. * Is able to provide archival or newly obtained core/excisional biopsy of the primary lung tumor or lymph node metastasis.
  1. * Has one of the following tumor locations/types: NSCLC involving the superior sulcus, large-cell neuro-endocrine cancer, mixed tumors containing small cell and non-small cell elements, or sarcomatoid tumor.
  2. * Has Grade ≥2 peripheral neuropathy.
  3. * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
  4. * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
  5. * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
  6. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  7. * Received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids.
  8. * Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
  9. * Known additional malignancy that is progressing or has required active treatment within the past 5 years.
  10. * Severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
  11. * Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid) is allowed.
  12. * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  13. * Active infection requiring systemic therapy.
  14. * Hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or Hepatitis C virus (defined as detectable hepatitis C virus (HCV) ribonucleic acid (RNA) \[qualitative\]) infection.
  15. * Known history of human immunodeficiency virus (HIV) infection.
  16. * History of allogeneic tissue/solid organ transplant.

Contacts and Locations

Study Contact

Toll Free Number
CONTACT
1-888-577-8839
Trialsites@msd.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

MedStar Franklin Square Medical Center ( Site 0033)
Baltimore, Maryland, 21237
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-14
Study Completion Date2032-02-07

Study Record Updates

Study Start Date2025-03-14
Study Completion Date2032-02-07

Terms related to this study

Keywords Provided by Researchers

  • Programmed Cell Death-1 (PD1, PD-1)
  • Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)
  • Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

Additional Relevant MeSH Terms

  • Lung Neoplasm Malignant