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Pembrolizumab With or Without Maintenance MK‑2870 in Metastatic Squamous NSCLC
EU CTIS ID: 2023-510128-66-00
What this study is testing
To compare pembrolizumab with or without maintenance MK-2870 with respect to OS
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) (Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8).
- Has adequate organ function.
- For Maintenance only (prior to randomization): is without disease progression of their NSCLC, as determined by blinded independent central review (BICR) using RECIST 1.1 after completion of study-specified Induction with an evaluable scan at Week 12 or most recent scan before randomization.
- For Maintenance only (prior to randomization): has ECOG PS of 0 or 1 as assessed at the Prerandomization Visit.
- For Maintenance only (prior to randomization): all AEs (with the exception of alopecia, Grade 2 fatigue, and Grade ≤2 endocrine-related AEs requiring treatment or hormone replacement) have recovered.
- Measurable disease per response evaluation criteria in solid tumors (RECIST) 1.1 as assessed by the local site investigator/radiology.
You likely can't join if
- Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
- Received prior treatment with a topoisomerase I inhibitor-containing ADC.
- Is currently receiving a strong inducer/inhibitor of Cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period before starting MK-2870 is 2 weeks.
See the full eligibility criteria
Who can join
- Histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) (Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8).
- Has adequate organ function.
- For Maintenance only (prior to randomization): is without disease progression of their NSCLC, as determined by blinded independent central review (BICR) using RECIST 1.1 after completion of study-specified Induction with an evaluable scan at Week 12 or most recent scan before randomization.
- For Maintenance only (prior to randomization): has ECOG PS of 0 or 1 as assessed at the Prerandomization Visit.
- For Maintenance only (prior to randomization): all AEs (with the exception of alopecia, Grade 2 fatigue, and Grade ≤2 endocrine-related AEs requiring treatment or hormone replacement) have recovered.
- Measurable disease per response evaluation criteria in solid tumors (RECIST) 1.1 as assessed by the local site investigator/radiology.
- Life expectancy of at least 3 months.
- Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 assessed within 7 days before allocation.
- Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided.
- 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 before allocation.
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- Participants who have adverse events (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). Note: Participants with Grade =2 neuropathy are eligible.
What rules you out
- Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
- Received prior treatment with a topoisomerase I inhibitor-containing ADC.
- Is currently receiving a strong inducer/inhibitor of Cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period before starting MK-2870 is 2 weeks.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients or to another biologic therapy.
- Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
- Active infection requiring systemic therapy.
- History of allogeneic tissue/solid organ transplant.
- Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea).
- 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 corrected QT interval by Fridericia (QTcF) interval to >480 ms, and other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention.
- HIV-infected participants who have been newly diagnosed or with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
- Received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC. Note: Prior treatment with chemotherapy and/or radiation as a part of neoadjuvant or adjuvant therapy or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
- Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T lymphocyte-associated protein 4, OX-40, CD137). Note: Prior treatment with an anti-PD-1 or anti-PD-L1 agent for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
- Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC).
- Received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United States
- Peru
- Argentina
- Taiwan
- Israel
- Colombia
- Chile
- Canada
- China
- Brazil
- United Kingdom
- Thailand
- Korea, Republic of
- Turkey
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United States; Peru; Argentina; Taiwan; Israel and 9 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 EU CTIS; the study team decides eligibility.