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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)

NCT06305754 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2026-05-22

No results posted yet for this study

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 is that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to overall survival (OS).

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Interventions

BIOLOGICAL

Sacituzumab tirumotecan

4 mg/kg via IV infusion

DRUG

Pemetrexed

500 mg/m\^2 via IV infusion

DRUG

Carboplatin

AUC 5 mg/mL\*min via IV infusion

DRUG

H1 Receptor Antagonist

Administered as rescue medication per approved product label

DRUG

H2 Receptor Antagonist

Administered as rescue medication per approved product label

DRUG

Acetaminophen (or equivalent)

Administered as rescue medication per approved product label

DRUG

Dexamethasone (or equivalent)

Administered as rescue medication per approved product label

DRUG

Steroid Mouthwash (dexamethasone or equivalent)

Administered as rescue medication per approved product label

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-11
Primary Completion
2028-08-17
Completion
2030-06-14
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • China
  • Colombia
  • France
  • India
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Poland
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06305754 on ClinicalTrials.gov