Sacituzumab Tirumotecan for Advanced Non-Small Cell Lung Cancer
This study is testing a treatment called sacituzumab tirumotecan against standard chemotherapy (docetaxel or pemetrexed) for people with advanced non-small cell lung cancer (NSCLC). You might be able to join if your cancer has specific genetic changes, such as EGFR mutations or other alterations like ALK, ROS1, or BRAF V600E. The main goal is to see if sacituzumab tirumotecan helps people live longer compared to chemotherapy, especially for those with EGFR mutations. The study plans to enroll 556 participants, but its current status is unclear.
- Study design
- This interventional study plans to enroll 556 participants. It compares sacituzumab tirumotecan to chemotherapy.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Overall survival will be measured for up to approximately 41 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06074588
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)
Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatmentMerck Sharp & Dohme LLC
~556 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Sacituzumab tirumotecanDocetaxelPemetrexed
At a glance
Recruiting sites
0 of 195 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival (OS) of Participants with NSCLC with Epidermal Growth Factor Receptor (EGFR) Mutations
Measured over Up to approximately 41 months
Conditions
Where it's being run
195 sites across 121 statesTaiwan9
Region M. de Santiago7
Japan6
South Korea6
National Capital Region5
Brazil4
Attica4
Hong Kong4
Study leadership
- Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
What this trial measures
- Overall Survival (OS) of Participants with NSCLC with Epidermal Growth Factor Receptor (EGFR) MutationsUp to approximately 41 months
OS is defined as the time from randomization to death due to any cause.