RecruitingPhase 3

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)

A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests pembrolizumab with or without sacituzumab tirumotecan after surgery for non-small cell lung cancer. It is for adults whose removed lung tissue still had cancer cells after treatment before surgery. Researchers want to learn if adding the drug helps people stay free of cancer longer and is safe.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have confirmed non-small cell lung cancer that can be removed by surgery: stage II, IIIA, or IIIB with cancer in certain lymph nodes.
  • Do not need treatment aimed at EGFR or ALK, two proteins that can help cancer grow, as the main treatment.
  • Be able to have surgery and receive pembrolizumab plus two platinum-based chemotherapy drugs before surgery.
  • For the after-surgery part: cancer cells must still be found in the tissue removed during surgery.
  • For the after-surgery part: provide tumor tissue for tests of proteins called PD-L1 and TROP2.
  • For the after-surgery part: scans must show no remaining cancer within 28 days before assignment to a treatment group.
  • Side effects from earlier cancer treatment must be mild or back to their earlier level. Hormone-related side effects may be allowed if treated with replacement hormones.
  • If you have HIV, it must be well controlled with medicine. Hepatitis B requires at least 4 weeks of treatment and no virus detected at screening. Past hepatitis C requires no virus detected at least 4 weeks before study treatment.

Who can't join

  • Have a tumor in the upper groove of the lung, large-cell neuroendocrine cancer, a sarcomatoid tumor, or any small-cell lung cancer.
  • Have moderate or worse nerve damage outside the brain and spinal cord, severe eye problems listed in the study, or a history of inflammatory bowel disease.
  • Have serious, uncontrolled heart or blood vessel disease, including certain serious problems within the past 6 months.
  • Have already had treatment before surgery for this lung cancer; cancer drugs or an experimental drug or device within 4 weeks; or radiation within 2 weeks. Radiation side effects needing steroids also exclude you.
  • Have had a live vaccine within 30 days, have a weak immune system, or have used certain immune-suppressing medicines within 7 days. This includes daily steroids above the equivalent of 10 mg of prednisone.
  • Have another cancer that is growing or needed treatment within 5 years, or an illness where the immune system attacks the body that needed whole-body treatment within 2 years.
  • Have past, current, or suspected lung inflammation not caused by infection; an infection needing whole-body treatment; active hepatitis B and C together; or HIV with past Kaposi's sarcoma or multicentric Castleman's disease.
  • Have had a donor tissue or organ transplant, have not healed well from major surgery, have ongoing surgery problems, or have had a severe allergic reaction to a study drug, its ingredients, or another biologic treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (51)

AR

CA

CT

FL

GA

IL

IN

KY

LA

ME

MN

MO

ND

NJ

NV

  • Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0037) · Reno, NV 89502Study Coordinator · Study contact · 775-982-5050More trials in Reno

NY

OK

OR

PA

SC

SD

TN

TX

UT