RECRUITING

Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)

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Conditions

Non-small Cell Lung Cancer (NSCLC)Anaplastic lymphoma kinase (ALK)Antibody-drug conjugate (ADC)Epidermal growth factor receptor (EGFR)Trophoblast cell-surface antigen 2 (TROP2)

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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 purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20 S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypotheses are that sacituzumab tirumotecan is: (1) superior to chemotherapy with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations; and (2) superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.

Official Title

A Randomized, Open-label, Phase 3 Study of MK-2870 vs Chemotherapy (Docetaxel or Pemetrexed) in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations

Quick Facts

Study Start:2023-11-12
Study Completion:2030-03-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06074588

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. * Histologically- or cytologically-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations.
  2. * Documentation of locally assessed radiological disease progression while on or after last treatment based on Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1.
  3. * Participants with genome mutations must have received 1 or 2 prior lines of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), including a third generation TKI for participants with a T790M mutation; and 1 platinum-based therapy after progression on or after EGFR TKI.
  4. * Measurable disease per RECIST 1.1 as assessed by the local site investigator.
  5. * Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
  6. * Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline.
  7. * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
  8. * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
  9. * Have an ECOG performance status of 0 or 1 within 3 days before randomization.
  1. * Has predominantly squamous cell histology NSCLC.
  2. * Has mixed tumor(s) with small cell elements.
  3. * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
  4. * Has Grade ≥2 peripheral neuropathy.
  5. * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
  6. * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
  7. * Has an EGFR T790M mutation and has not received a third generation EGFR TKI (eg, osimertinib).
  8. * Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before randomization.
  9. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
  10. * Completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
  11. * Received radiation therapy to the lung that is \>30 Gy within 6 months of the first dose of study intervention.
  12. * Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC).
  13. * Received prior treatment with a topoisomerase I-containing ADC.
  14. * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
  15. * Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  16. * Active infection requiring systemic therapy.
  17. * History of noninfectious pneumonitis/ILD that required steroids or has current pneumonitis/ILD.
  18. * Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks, and are off steroids 3 days prior to dosing with study medication.
  19. * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
  20. * Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.

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)

UCLA Hematology/Oncology - Santa Monica-Oncology ( Site 0023)
Los Angeles, California, 90404
United States
Mid Florida Hematology and Oncology Center ( Site 0005)
Orange City, Florida, 32763
United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003)
Marietta, Georgia, 30060
United States
Karmanos Cancer Institute ( Site 0018)
Detroit, Michigan, 48201
United States
Hattiesburg Clinic Hematology/Oncology ( Site 0010)
Hattiesburg, Mississippi, 39401
United States
University Of Nebraska Medical Center ( Site 0011)
Omaha, Nebraska, 68198
United States
Capital Health Medical Center - Hopewell ( Site 0006)
Pennington, New Jersey, 08534
United States
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0015)
Cincinnati, Ohio, 45219
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 Date2023-11-12
Study Completion Date2030-03-11

Study Record Updates

Study Start Date2023-11-12
Study Completion Date2030-03-11

Terms related to this study

Keywords Provided by Researchers

  • Anaplastic lymphoma kinase (ALK)
  • Antibody-drug conjugate (ADC)
  • Epidermal growth factor receptor (EGFR)
  • Trophoblast cell-surface antigen 2 (TROP2)

Additional Relevant MeSH Terms

  • Non-small Cell Lung Cancer (NSCLC)