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OncoMatch/Clinical Trials/NCT06312137

A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)

Is NCT06312137 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments for non small cell lung cancer.

Phase 3RecruitingMerck Sharp & Dohme LLCNCT06312137Data as of Sep 2026Location: International · 31 countries

Treatment: Sacituzumab tirumotecan · Pembrolizumab · Cisplatin · Pemetrexed · Gemcitabine · Carboplatin · Paclitaxel · Rescue medicationThis study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Pembrolizumab

Chemotherapy

CisplatinPemetrexedGemcitabineCarboplatinPaclitaxel

Other

Sacituzumab tirumotecanRescue medication

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR not indicated as primary therapy

Has confirmation that either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated as primary therapy

Required: ALK not indicated as primary therapy

Has confirmation that either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated as primary therapy

Required: PD-L1 (CD274) expression (testing required; no eligibility threshold specified)

Tumor tissue sample from surgical resection has been provided for determination of programmed cell death ligand 1 (PD-L1) ... status by central vendor before randomization

Required: TACSTD2 expression (testing required; no eligibility threshold specified)

Tumor tissue sample from surgical resection has been provided for determination of ... trophoblast cell surface antigen 2 (TROP2) status by central vendor before randomization

Disease stage

Required: Stage II, IIIA, IIIB

Prior therapy

Must have received: neoadjuvant pembrolizumab and platinum-based doublet chemotherapy — current NSCLC diagnosis

Is able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy

Cannot have received: neoadjuvant therapy for current NSCLC diagnosis

Has received prior neoadjuvant therapy for their current NSCLC diagnosis

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • UAMS Winthrop P. Rockefeller Cancer Institute ( Site 0060) · Little Rock, Arkansas
  • Highlands Oncology Group-Research Department ( Site 0062) · Springdale, Arkansas
  • Beverly Hills Cancer Center ( Site 0070) · Beverly Hills, California
  • The Angeles Clinic and Research Institute ( Site 0040) · Los Angeles, California
  • The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate ( Site 0079) · Los Angeles, California

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06312137 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior neoadjuvant therapy for current NSCLC diagnosis disqualifies patients from enrollment.

Does this trial require EGFR?

Yes, EGFR not indicated as primary therapy is a required biomarker for enrollment.

Does this trial require ALK?

Yes, ALK not indicated as primary therapy is a required biomarker for enrollment.

Does this trial require CD274?

Yes, CD274 expression is a required biomarker for enrollment.

What disease stage is eligible?

Stage II or IIIA or IIIB is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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