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Comparing sacituzumab tirumotecan to standard chemotherapy for advanced lung cancer

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

PHASE3 · Merck Sharp & Dohme LLC · NCT06305754

This study tests if a new drug called sacituzumab tirumotecan can help people with advanced lung cancer live longer and feel better compared to standard chemotherapy.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment520 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC (industry)
Drugs / interventionsradiation, sacituzumab, chemotherapy
Locations156 sites (Oakland, California and 155 other locations)
Trial IDNCT06305754 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of sacituzumab tirumotecan compared to a combination of pemetrexed and carboplatin in patients with advanced nonsquamous non-small cell lung cancer (NSCLC) who have not responded to previous EGFR tyrosine kinase inhibitors. Participants will be randomly assigned to receive either the experimental drug or the standard chemotherapy regimen. The primary goals are to assess progression-free survival and overall survival between the two treatment groups.

Who should consider this trial

Good fit: Ideal candidates are individuals with advanced nonsquamous NSCLC who have progressed on prior EGFR tyrosine kinase inhibitors.

Not a fit: Patients with predominantly squamous cell histology NSCLC or those with significant peripheral neuropathy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective option for patients with advanced NSCLC who have exhausted prior therapies.

How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific comparison is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.
* Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load.
* Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
* 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 are 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.
* Active infection requiring systemic therapy.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* Concurrent active HBV and HCV infection.
* History of allogeneic tissue/solid organ transplant.
* Participants who have not adequately recovered from major surgery or have ongoing surgical complications.

Where this trial is running

Oakland, California and 155 other locations

+106 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Non-small Cell Lung Cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.