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Looking for participantsPhase3

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)

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06312137

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Sacituzumab tirumotecan (biological), Pembrolizumab (biological), Cisplatin (drug), Pemetrexed (drug)
How long the study runs
Study runs about 126 months (dates as stated)
About the drug or intervention
Sacituzumab tirumotecan — biological: Sacituzumab tirumotecan to be administered as 4mg/kg IV infusion q2w for up to 24 weeks · Pembrolizumab — biological: Pembrolizumab to be administered 400mg by IV infusion q6w for up to 42 weeks · Cisplatin — drug: Cisplatin is administered as 75 mg/m\^2 IV infusion q3w for up to 12 weeks as background treatment in neoadjuvant phase · Pemetrexed — drug: Pemetrexed will be administered in the neoadjuvant phase as 500 mg/m\^2 IV infusion q3w for up to 12 weeks as background treatment in participants with nonsquamous NSCLC. · Gemcitabine — drug: Gemcitabine will be administered in the neoadjuvant phase as 1000 mg/m\^2 or 1250 mg/m\^2 IV infusion on day 1 and day 8 q3w for up to 24 weeks as background treatment in participants with squamous NSCLC. · Carboplatin — drug: 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. · Paclitaxel — drug: Paclitaxel will be administered in the neoadjuvant phase as 175 mg/m\^2 or 200 mg/m\^2 IV infusion q3w for up to 12 weeks as background treatment. · Rescue medication — drug: Participants are permitted to take rescue medications to prevent hypersensitivity and/or infusion reactions as a premedication to study treatment.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
780
Started
2024-04-03
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for non small cell lung cancer
  • • Phase3 - 780 participants
  • • This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with non small cell lung cancer

Where?

  • • Cambridge - Addenbrooke's Hospital ( Site 3217)
  • • Northwood - Mount Vernon Hospital ( Site 3218)
  • • London - St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3203)
  • • Oxford - Churchill Hospital ( Site 3219)
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

Non Small Cell Lung Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

EGFRALKPD-L1HBsAg positive

Treatment history

Treatments you must have had:

  • ✓ recovered to ≤Grade 1 or baseline
  • ✓ well controlled HIV on antiretroviral therapy (ART)

What the study is looking for

  • ✓Has confirmation that either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase...
  • ✓Is able to undergo surgery based on opinion of investigator after consultation with surgeon
  • ✓Is able to receive before surgery pembrolizumab and platinum-based doublet drug treatment
  • ✓Applies to screening for the after surgery period only, before randomization: Has not achieved pathological complete...
  • ✓Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)

Who cannot take part

  • ✗Has one of the following tumor locations/types:
  • ✗NSCLC involving the superior sulcus
  • ✗Large cell neuro-endocrine cancer (LCNEC)
  • ✗Sarcomatoid tumor
  • ✗Diagnosis of SCLC or, for mixed tumors, presence of small cell elements
See the full criteria
The key inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Has histological or cytological confirmation of squamous or nonsquamous non-small cell lung cancer (NSCLC), resectable clinical Stage II, IIIA or IIIB (with nodal involvement \[N2\]) per AJCC eighth edition guidelines * Has confirmation that either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated as primary therapy * Is able to undergo surgery based on opinion of investigator after consultation with surgeon * Is able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy * Applies to screening for the adjuvant period only, before randomization: Has not achieved pathological complete response (pCR) at surgery by local review of pathology. * Applies to screening for the adjuvant period only, before randomization: Tumor tissue sample from surgical resection has been provided for determination of programmed cell death ligand 1 (PD-L1) and trophoblast cell surface antigen 2 (TROP2) status by central vendor before randomization into the adjuvant period * Applies to screening for the adjuvant period only, before randomization: Confirmed to be disease-free based on re-baseline radiological assessment as documented by contrast enhanced chest/abdomen/pelvis computed tomography (CT) (or magnetic resonance imaging (MRI)) within 28 days before randomization * Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART) * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load at screening * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at least 4 weeks before the start of study intervention Exclusion Criteria: * Has one of the following tumor locations/types: * NSCLC involving the superior sulcus * Large cell neuro-endocrine cancer (LCNEC) * Sarcomatoid tumor * Diagnosis of SCLC or, for mixed tumors, presence of small cell elements * Has Grade ≥2 peripheral neuropathy * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QT corrected for heart rate by Fridericia's cube root formula (QTcF) interval to \>480 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention * Has received prior neoadjuvant therapy for their current NSCLC diagnosis * Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention * Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication * Has a known additional malignancy that is progressing or has required active treatment within the past 5 years * Has an active autoimmune disease that has required systemic treatment in the past 2 years * Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis, has current ILD/pneumonitis, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at screening * Has an active infection requiring systemic therapy * Is an HIV-infected participant with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has a concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection * Has a history of allogeneic tissue/solid organ transplant * Has not adequately recovered from major surgery or have ongoing surgical complications * Severe hypersensitivity (≥Grade 3) to study intervention, any of its excipients, and/or to another biologic therapy

Where Is This Study? (5 UK sites)

Addenbrooke's Hospital ( Site 3217)

Cambridge CB2 2QQ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441223 805000

Mount Vernon Hospital ( Site 3218)

Northwood HA6 2RN, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator02038262403

St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3203)

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator02073777000

Churchill Hospital ( Site 3219)

Oxford OX3 7LE, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+44 (0) 300 304 7777

Freeman Hospital-Northern Centre for Cancer Care ( Site 3212)

Newcastle upon Tyne NE7 7DN, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator01912336161

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09