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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)

NCT06312137 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 780

Last updated 2026-05-22

No results posted yet for this study

Summary

This 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).

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Cisplatin

Cisplatin is administered as 75 mg/m2 IV infusion q3w for up to 12 weeks as background treatment in neoadjuvant phase

DRUG

Pemetrexed

Pemetrexed will be administered in the neoadjuvant phase as 500 mg/m2 IV infusion q3w for up to 12 weeks as background treatment in participants with nonsquamous NSCLC.

DRUG

Gemcitabine

Gemcitabine will be administered in the neoadjuvant phase as 1000 mg/m2 or 1250 mg/m2 IV infusion on day 1 and day 8 q3w for up to 24 weeks as background treatment in participants with squamous NSCLC.

DRUG

Carboplatin

Carboplatin will be administered in the neoadjuvant phase as AUC 5 mg/mL/min or AUC 6 mg/mL/min IV infusion q3w for up to 12 weeks as background treatment.

DRUG

Paclitaxel

Paclitaxel will be administered in the neoadjuvant phase as 175 mg/m2 or 200 mg/m2 IV infusion q3w for up to 12 weeks as background treatment.

DRUG

Rescue medication

Participants are allowed to take rescue medication to prevent hypersensitivity and/or infusion reactions as a premedication to study treatment. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are antihistamine, H2 receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent. A steroid mouthwash (dexamethasone or equivalent) may be given as prophylaxis for stomatitis/oral mucositis.

BIOLOGICAL

Sacituzumab tirumotecan

Sacituzumab tirumotecan to be administered as 4mg/kg IV infusion q2w for up to 24 weeks

BIOLOGICAL

Pembrolizumab

Pembrolizumab to be administered 400mg by IV infusion q6w for up to 42 weeks

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-03
Primary Completion
2034-02-21
Completion
2034-10-23
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • Czechia
  • France
  • Germany
  • Greece
  • Hong Kong
  • Israel
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • New Zealand
  • Norway
  • Peru
  • Poland
  • Portugal
  • Romania
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06312137 on ClinicalTrials.gov