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Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Randomized, Open-label, Phase 3 Study of MK-2870 vs. Platinum Doublets in Participants With EGFR-mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors

NCT06305754•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate sacituzumab tirumotecan versus pemetrexed in combination with carboplatin for the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-squamous non-small cell lung cancer (NSCLC). Participants in this study have NSCLC that has continued to progress on prior treatment with EGFR tyrosine kinase inhibitors (TKIs). The primary hypotheses of this study are that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to progression-free survival (PFS) and overall survival (OS).

Detailed Description

Participants will be randomized 1:1 into two arms: * Sacituzumab tirumotecan * Pemetrexed plus Carboplatin Participants will receive treatment until any of the criteria for discontinuation of study intervention are met.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed diagnosis of advanced-stage nonsquamous non-small cell lung cancer (NSCLC).
•Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline.
•Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
•Life expectancy of at least 3 months.

Exclusion Criteria

•Predominantly squamous cell histology NSCLC.
•History of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
•Grade ≥2 peripheral neuropathy.
•History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
•Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
•Uncontrolled, or significant cardiovascular disease or cerebrovascular disease.
•Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
•Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
•Received radiation therapy to the lung that is \>30 Gray within 6 months of the first dose of study intervention.
•Known active central nervous system metastases and/or carcinomatous meningitis.
+6 more criteria

Locations (156)

Kaiser Permanente - Oakland ( Site 0054)

Oakland, California, United States

Kaiser Permanente - Roseville ( Site 0055)

Roseville, California, United States

Kaiser Permanente - San Francisco ( Site 0056)

San Francisco, California, United States

Kaiser Permanente - Santa Clara ( Site 0057)

Santa Clara, California, United States

Kaiser Permanente-Kaiser Permanente ( Site 0036)

Vallejo, California, United States

Kaiser Permanente - Walnut Creek ( Site 0058)

Walnut Creek, California, United States

Mid Florida Hematology and Oncology Center ( Site 0005)

Orange City, Florida, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003)

Marietta, Georgia, United States

University of Michigan ( Site 0009)

Ann Arbor, Michigan, United States

Cox Medical Center North - Cox Medical Center/ Hematology/Medical Oncology ( Site 0051)

Springfield, Missouri, United States

Key Dates

Start Date

June 11, 2024

Primary Completion Date

September 12, 2028

Completion Date

June 14, 2030

Last Updated

March 20, 2026

Enrollment

520

ESTIMATED participants

Conditions

Non-small Cell Lung Cancer (NSCLC)

Interventions

Sacituzumab tirumotecan

BIOLOGICAL

Pemetrexed

DRUG

Carboplatin

DRUG

H1 Receptor Antagonist

DRUG

H2 Receptor Antagonist

DRUG

Acetaminophen (or equivalent)

DRUG

Dexamethasone (or equivalent)

DRUG

Steroid Mouthwash (dexamethasone or equivalent)

DRUG

Contacts

Toll Free Number

CONTACT

1-888-577-8839 Trialsites@msd.com

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

NCT05920356

Non-Small Cell Lung Cancer (NSCLC)

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Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors

NCT06128551

Non-Small Cell Lung Cancer (NSCLC)Colorectal Cancer+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Inclusion Criteria

Exclusion Criteria

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors

Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer

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Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors