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
- UAMS Winthrop P. Rockefeller Cancer Institute ( Site 0060) · Little Rock, AR 72205Study Coordinator · Study contact · 601-278-6499More trials in Little Rock
- Highlands Oncology Group-Research Department ( Site 0062) · Springdale, AR 72762Study Coordinator · Study contact · 479-334-2562More trials in Springdale
CA
- Beverly Hills Cancer Center ( Site 0070) · Beverly Hills, CA 90211Study Coordinator · Study contact · 310-432-8933More trials in Beverly Hills
- The Angeles Clinic and Research Institute ( Site 0040) · Los Angeles, CA 90025More trials in Los Angeles
- The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate ( Site 0079) · Los Angeles, CA 90025More trials in Los Angeles
- UCLA Clinical & Translational Research Center (CTRC) ( Site 0033) · Los Angeles, CA 90095Study Coordinator · Study contact · 424-325-9070More trials in Los Angeles
- Hoag Memorial Hospital Presbyterian ( Site 0096) · Newport Beach, CA 92663Study Coordinator · Study contact · 949-764-4060More trials in Newport Beach
- St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 4002) · Orange, CA 92868Study Coordinator · Study contact · 714-734-6220More trials in Orange
- San Francisco Oncology Associates ( Site 0066) · San Francisco, CA 94115Study Coordinator · Study contact · 415-600-1102More trials in San Francisco
CT
- Stamford Hospital ( Site 0083) · Stamford, CT 06902Study Coordinator · Study contact · 203-358-8879More trials in Stamford
FL
- Mayo Clinic in Florida ( Site 0014) · Jacksonville, FL 32224Study Coordinator · Study contact · 904-953-3570More trials in Jacksonville
- Mount Sinai Cancer Center ( Site 0038) · Miami Beach, FL 33140Study Coordinator · Study contact · 305-674-2625More trials in Miami Beach
- Mid Florida Hematology and Oncology Center ( Site 0018) · Orange City, FL 32763Study Coordinator · Study contact · 386-960-7070More trials in Orange City
GA
- Piedmont Atlanta Hospital ( Site 4000) · Atlanta, GA 30318Study Coordinator · Study contact · 404-425-1777More trials in Atlanta
- Emory University School of Medicine-Phase I ( Site 0056) · Atlanta, GA 30322Study Coordinator · Study contact · 404-778-1900More trials in Atlanta
- Northside Hospital ( Site 0055) · Atlanta, GA 30342Study Coordinator · Study contact · 404-851-8000More trials in Atlanta
- Centricity Research Columbus Cancer Center ( Site 0005) · Columbus, GA 31904More trials in Columbus
- Southeastern Regional Medical Center ( Site 0065) · Newnan, GA 30265Study Coordinator · Study contact · 770-400-6000More trials in Newnan
- Lewis Cancer and Research Pavilion ( Site 0063) · Savannah, GA 31405Study Coordinator · Study contact · 912-819-5704More trials in Savannah
- Archbold Cancer Center ( Site 0071) · Thomasville, GA 31792Study Coordinator · Study contact · 229-584-5417More trials in Thomasville
IL
- Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0017) · Elmhurst, IL 60126More trials in Elmhurst
- North Shore University Health System ( Site 4014) · Evanston, IL 60201Study Coordinator · Study contact · 847-540-2112More trials in Evanston
- Accellacare of Duly ( Site 4005) · Lisle, IL 60532Study Coordinator · Study contact · 630-545-7760More trials in Lisle
- Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0078) · Naperville, IL 60540More trials in Naperville
IN
- Parkview Research Center at Parkview Regional Medical Center ( Site 0089) · Fort Wayne, IN 46845Study Coordinator · Study contact · 260-266-6626More trials in Fort Wayne
- Indiana University Health Arnett Cancer Center ( Site 0076) · Lafayette, IN 47904Study Coordinator · Study contact · 765-838-6885More trials in Lafayette
KY
- Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0061) · Edgewood, KY 41017Study Coordinator · Study contact · 859-301-4736More trials in Edgewood
LA
- LSU Health Baton Rouge North Clinic ( Site 4003) · Baton Rouge, LA 70805Study Coordinator · Study contact · 225-765-7956More trials in Baton Rouge
- Our Lady of the Lake Physician Group-Medical Oncology ( Site 0080) · Baton Rouge, LA 70808Study Coordinator · Study contact · 225-765-7956More trials in Baton Rouge
ME
- New England Cancer Specialists ( Site 0095) · Westbrook, ME 04092Study Coordinator · Study contact · 207-303-3300More trials in Westbrook
MN
- Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0027) · Minneapolis, MN 55407Study Coordinator · Study contact · 888-425-5462More trials in Minneapolis
- Mayo Clinic - Rochester ( Site 0073) · Rochester, MN 55905Study Coordinator · Study contact · 904-953-1050More trials in Rochester
MO
- Mercy South - David M Sindelar Cancer Center ( Site 0098) · St Louis, MO 63128Study Coordinator · Study contact · 314-525-4928More trials in St Louis
- Mercy Research - David C. Pratt Cancer Center ( Site 0006) · St Louis, MO 63141Study Coordinator · Study contact · 314-251-4400More trials in St Louis
ND
- Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0057) · Fargo, ND 58102Study Coordinator · Study contact · 701-234-6161More trials in Fargo
NJ
- Atlantic Health Morristown Medical Center ( Site 0077) · Morristown, NJ 07960Study Coordinator · Study contact · 973-971-7000More trials in Morristown
NV
- Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0037) · Reno, NV 89502Study Coordinator · Study contact · 775-982-5050More trials in Reno
NY
- Cayuga Medical Center ( Site 0086) · Ithaca, NY 14850Study Coordinator · Study contact · 607-277-4341More trials in Ithaca
- University Hospital at Stony Brook ( Site 0054) · Stony Brook, NY 11794Study Coordinator · Study contact · 631-372-7212More trials in Stony Brook
- White Plains Hospital ( Site 0091) · White Plains, NY 10601Study Coordinator · Study contact · 914-681-0600More trials in White Plains
OK
- Hightower Clinical, LLC ( Site 0084) · Oklahoma City, OK 73102Study Coordinator · Study contact · 405-479-8331More trials in Oklahoma City
OR
- Oregon Health and Science University ( Site 0052) · Portland, OR 97239Study Coordinator · Study contact · 503-494-0283More trials in Portland
PA
- Penn State Milton S. Hershey Medical Center-Penn State Cancer Institute ( Site 0059) · Hershey, PA 17033Study Coordinator · Study contact · 717-531-0003More trials in Hershey
- Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0068) · Lancaster, PA 17601Study Coordinator · Study contact · 717-544-0511More trials in Lancaster
SC
- Saint Joseph's Candler Health System ( Site 4010) · Bluffton, SC 29910Study Coordinator · Study contact · 912-819-5704More trials in Bluffton
- Medical University of South Carolina-Hollings Cancer Center ( Site 0045) · Charleston, SC 29425Study Coordinator · Study contact · 843-792-4271More trials in Charleston
SD
- Sanford Cancer Center ( Site 0053) · Sioux Falls, SD 57104Study Coordinator · Study contact · 605-328-8800More trials in Sioux Falls
- Avera Cancer Institute- Research ( Site 0090) · Sioux Falls, SD 57105Study Coordinator · Study contact · 605-322-3295More trials in Sioux Falls
TN
- University of Tennessee Medical Center Knoxville ( Site 0082) · Knoxville, TN 37920Study Coordinator · Study contact · 865-305-9000More trials in Knoxville
TX
- Millennium Research & Clinical Development ( Site 0039) · Houston, TX 77090More trials in Houston
UT
- Huntsman Cancer Institute ( Site 0042) · Salt Lake City, UT 84112-5500Study Coordinator · Study contact · 801-587-7000More trials in Salt Lake City