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Tests treatment safety and results for Non Small Cell Lung Cancer
Official title 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)
ClinicalTrials.gov ID: NCT06312137
What this study is testing
What is Sacituzumab tirumotecan?
Sacituzumab tirumotecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non small cell lung cancer.
Also referred to as MK-2870, sac-TMT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The key inclusion and
You likely can't join if
- 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...
- Has confirmation that either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated...
- 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...
See the full eligibility criteria
- The key inclusion and
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Springdale, Arkansas, United States
- Beverly Hills, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Orange, California, United States
- San Francisco, California, United States
- Stamford, Connecticut, United States
- Jacksonville, Florida, United States
- Miami Beach, Florida, United States
- Orange City, Florida, United States
- Atlanta, Georgia, United States
- Columbus, Georgia, United States
- Newnan, Georgia, United States
- Savannah, Georgia, United States
- Thomasville, Georgia, United States
- Elmhurst, Illinois, United States
- Lisle, Illinois, United States
- Naperville, Illinois, United States
- Fort Wayne, Indiana, United States
+ 206 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Springdale, Arkansas, United States; Beverly Hills, California, United States; Los Angeles, California, United States; Newport Beach, California, United States; Orange, California, United States and 220 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.