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Comparing sacituzumab tirumotecan to chemotherapy for advanced lung cancer with specific mutations

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

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT06074588

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

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment556 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionsosimertinib, radiation, sacituzumab, chemotherapy
Locations184 sites (Los Angeles, California and 183 other locations)
Trial IDNCT06074588 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of sacituzumab tirumotecan compared to standard chemotherapy (docetaxel or pemetrexed) in patients with previously treated advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) that has specific genetic mutations. The study focuses on patients with EGFR mutations and other genomic alterations, aiming to determine if sacituzumab tirumotecan can improve progression-free survival and overall survival compared to traditional chemotherapy. Participants must have documented disease progression while on prior treatments and meet specific eligibility criteria regarding their cancer's genetic profile.

Who should consider this trial

Good fit: Ideal candidates are patients with advanced or metastatic nonsquamous NSCLC who have specific EGFR mutations or other genomic alterations and have received prior treatments.

Not a fit: Patients with squamous cell lung cancer or those who have not undergone prior treatment 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 lung cancer who have specific genetic mutations.

How similar studies have performed: Other studies have shown promising results with similar approaches using targeted therapies in lung cancer, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 for at least 2 weeks, and are off steroids 3 days prior to dosing with study medication.
* 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.

Where this trial is running

Los Angeles, California and 183 other locations

+134 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 → Find more trials like this →
Conditions Non-small Cell Lung CancerAnaplastic lymphoma kinaseAntibody-drug conjugateEpidermal growth factor receptorTrophoblast cell-surface antigen 2
Last reviewed 2026-06-13 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.