sac-TMT / Nsclc / Pembrolizumab · Phase 3 Trial

Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]

ClinicalTrials.gov · August 7, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned Phase 3 randomized controlled trial comparing pembrolizumab with maintenance sacituzumab tirumotecan versus pembrolizumab alone in first-line metastatic squamous NSCLC, with overall survival as the primary endpoint. No results have been reported in this registry record; the study is currently recruiting.

What was studied

Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Non-small Cell Lung Cancer, NSCLC; age from 18 Years. Intervention: Maintenance Arm A: Pembrolizumab + sac-TMT. Compared with: Maintenance Arm B: Pembrolizumab Monotherapy — Active Comparator. n = 851. 215 sites across 26 countries.

Key findings

Safety

Study is actively recruiting; no efficacy or safety data are available

Who this may help

Results are not yet available. When completed, this trial will inform whether adding maintenance sacituzumab tirumotecan to pembrolizumab improves overall survival in metastatic squamous NSCLC compared to pembrolizumab alone.

Plain-language summary

This is a clinical trial registry record describing a planned Phase 3 study with no results posted; the record documents study design and hypothesis only, not clinical outcomes.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Overall survival (OS) (assessed at Up to ~50 months)

DesignPhase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationNon-small Cell Lung Cancer, NSCLC; age from 18 Years

Sample size851

InterventionMaintenance Arm A: Pembrolizumab + sac-TMT

ComparatorMaintenance Arm B: Pembrolizumab Monotherapy — Active Comparator

Setting215 sites across 26 countries

Reported figures

Quoted from the source exactly as published.

PhasePhase 3

Planned enrollment851

Primary outcome measureOverall survival (OS), up to ~50 months

Study typeInterventional randomized controlled trial

Clinical bottom line

Caveats

This is a registry record; no results have been posted or analyzed
Study is actively recruiting; no efficacy or safety data are available
No baseline characteristics, allocation method, or blinding strategy are reported in this record
No interim analysis results are reported

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Phase 3 randomized controlled trial with clear intervention and comparator arms

Directness

strong

Primary outcome is overall survival in metastatic squamous NSCLC first-line setting

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone

Risk of bias

insufficient

Study is actively recruiting; blinding and allocation methods not detailed in registry

Sample adequacy

strong

Estimated enrollment of 851 participants is substantial for Phase 3 oncology trial

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06422143). This is a study registration, not published results. Lead sponsor: Merck Sharp & Dohme LLC. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 851 participants (ESTIMATED). Conditions: Non-small Cell Lung Cancer, NSCLC. Interventions: BIOLOGICAL: Pembrolizumab; BIOLOGICAL: sac-TMT; DRUG: Carboplatin; DRUG: Paclitaxel; DRUG: Nab-paclitaxel. Primary outcome measures: Overall survival (OS) , Up to ~50 months. Brief summary: This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT06422143sac-TMTMerck Sharp & DohmeNsclcPembrolizumabCarboplatinNon Small Cell Lung CancerPaclitaxel