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NCT06074588

PHASE3

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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 hypothesis is that sacituzumab tirumotecan is 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

556

Start Date

2023-11-12

Completion Date

2030-03-11

Last Updated

2026-08-14

Healthy Volunteers

Conditions

Non-small Cell Lung Cancer (NSCLC)

Interventions

BIOLOGICAL

Sacituzumab tirumotecan

4 mg/kg of MK-sacituzumab tirumotecan by IV infusion

DRUG

Docetaxel

75 mg/m\^2 of docetaxel by IV Infusion

DRUG

Pemetrexed

500 mg/m\^2 of pemetrexed by IV infusion

The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Histologically- or cytologically-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations. * 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. * 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. * Measurable disease per RECIST 1.1 as assessed by the local site investigator. * Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided * Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline. * 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. * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy. * Have an ECOG performance status of 0 or 1 within 3 days before randomization. Exclusion Criteria: * Has predominantly squamous cell histology NSCLC. * Has mixed tumor(s) with small cell elements. * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease. * Has Grade ≥2 peripheral neuropathy. * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing. * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease. * Has an EGFR T790M mutation and has not received a third generation EGFR TKI (eg, osimertinib). * Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before randomization. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. * Completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids. * Received radiation therapy to the lung that is \>30 Gy within 6 months of the first dose of study intervention. * Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC). * Received prior treatment with a topoisomerase I-containing ADC. * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. * Known additional malignancy that is progressing or has required active treatment within the past 3 years. * Active infection requiring systemic therapy. * History of noninfectious pneumonitis/ILD that required steroids or has current pneumonitis/ILD. * Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable, radiologically stable for at least 4 weeks and do not require glucocorticoids for at least 14 days prior to randomization. * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * 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.

Locations (195)

UCLA Hematology/Oncology - Santa Monica ( Site 0023)

Los Angeles, California, United States

Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0001)

Jacksonville, Florida, 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

Karmanos Cancer Institute ( Site 0018)

Detroit, Michigan, United States

Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0027)

Rochester, Minnesota, United States

Hattiesburg Clinic Hematology/Oncology ( Site 0010)

Hattiesburg, Mississippi, United States

University Of Nebraska Medical Center ( Site 0011)

Omaha, Nebraska, United States

Englewood Hospital and Medical Center ( Site 0033)

Englewood, New Jersey, United States

Atlantic Health System Morristown Medical Center ( Site 0031)

Morristown, New Jersey, United States

Capital Health Medical Center - Hopewell ( Site 0006)

Pennington, New Jersey, United States

University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0015)

Cincinnati, Ohio, United States

Tennessee Oncology Chattanooga (Site 0038)

Chattanooga, Tennessee, United States

Tennessee Oncology (0036)

Nashville, Tennessee, United States

University of Texas MD Anderson (0037)

Houston, Texas, United States

VCU Health Adult Outpatient Pavillion ( Site 0026)

Richmond, Virginia, United States

St. George Private Hospital ( Site 3004)

Kogarah, New South Wales, Australia

Westmead Hospital ( Site 3000)

Westmead, New South Wales, Australia

Monash Health-Oncology Research ( Site 3001)

Clayton, Victoria, Australia

Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 3003)

Melbourne, Victoria, Australia

Hospital Santa Rita de Cassia (Site 0449)

Vitória, Espírito Santo, Brazil

Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0447)

Natal, Rio Grande do Norte, Brazil

Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0440)

Porto Alegre, Rio Grande do Sul, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0444)

Barretos, São Paulo, Brazil

ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica (Site 0448)

São Paulo, Brazil

Hospital Paulistano-Americas Oncologia ( Site 0441)

São Paulo, Brazil

A. C. Camargo Cancer Center-CAPEC ( Site 0442)

São Paulo, Brazil

Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0446)

São Paulo, Brazil

William Osler Health System ( Site 0205)

Brampton, Ontario, Canada

Princess Margaret Cancer Centre ( Site 0204)

Toronto, Ontario, Canada

Centro Investigacion Cancer James Lind ( Site 0513)

Temuco, Araucania, Chile

Clinica Universidad Catolica del Maule-Oncology ( Site 0501)

Talca, Maule Region, Chile

Centro de Estudios Clínicos SAGA (Site 0517)