RecruitingPhase 3

Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]

Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer

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 phase 3 study is for people with squamous non-small cell lung cancer that has spread to other parts of the body and has not yet been treated at this stage. Everyone first gets pembrolizumab with chemotherapy. The study tests whether adding sacituzumab tirumotecan (sac-TMT) to continued pembrolizumab helps people live longer.

This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).

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

Eligibility

Who can join

  • Have stage 4 squamous non-small cell lung cancer confirmed by a tissue or cell test, with tumors that can be measured on scans.
  • Be expected to live at least 3 months and be fully active or able to do light work.
  • Provide a stored or new tumor sample from an area not treated with radiation.
  • Have organs that work well enough for the study. Side effects from past cancer treatment must be mild or back to their usual level; treated hormone problems may be allowed.
  • If you have HIV, it must be well controlled with HIV medicines.
  • If you have hepatitis B, you must have taken antiviral medicine for at least 4 weeks, with no virus detected before study assignment. If you have had hepatitis C, no virus can be detected at screening.
  • To enter the continued-treatment stage, scans must show that the cancer has not worsened after the first study treatment. You must still be fully active or able to do light work.
  • For continued treatment, side effects must have cleared, with some exceptions for hair loss, tiredness, nerve problems, and hormone problems. You must not have had lung inflammation during the first study treatment.

Who can't join

  • Have any small cell lung cancer, cancer spread to the brain or spinal cord or their lining, or another cancer that is growing or needed treatment within the past 3 years.
  • Have had drug treatment for lung cancer after it spread, certain immune treatments, or certain antibody-linked cancer drugs targeting TROP2 or carrying a topoisomerase I blocker. Some treatments for lung cancer before it spread are allowed if finished at least 12 months before the spread was diagnosed.
  • Have had lung radiation above 30 Gray within 6 months, any radiation within 2 weeks, or radiation side effects needing steroids. Have had a live vaccine within 30 days or have not recovered from major surgery.
  • Have severe dry eyes, eyelid gland disease or inflammation, or disease of the clear front of the eye that slows healing. Have a history of inflammatory bowel disease, such as Crohn’s disease, ulcerative colitis, or chronic diarrhea.
  • Have serious uncontrolled heart or blood vessel disease, including certain serious problems within the past 6 months.
  • Have an immune disease that attacks your own body and needed whole-body treatment within 2 years, except allowed hormone replacement. Have current or suspected lung inflammation, past noninfectious lung inflammation needing steroids, or a donor tissue or organ transplant.
  • Have an active infection needing whole-body treatment. If you have HIV, also have a new or past diagnosis of Kaposi’s sarcoma or multicentric Castleman’s disease.
  • Have had a severe allergic reaction to a study drug, its ingredients, or another biologic medicine. Take certain medicines that strongly affect the liver enzyme CYP3A4 and cannot be stopped during the study.

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

Official eligibility criteria

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) \[Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8\] * Measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the local site investigator/radiology * Has life expectancy ≥3 months * Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 assessed within 7 days prior to 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) * Has adequate organ function * For Maintenance only (prior to randomization): is without disease progression of their NSCLC, as determined by 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, Grade ≤2 peripheral neuropathy, and Grade ≤2 endocrine-related AEs requiring treatment or hormone replacement) have recovered * For Maintenance only (prior to randomization): has not experienced a pneumonitis/interstitial lung disease (ILD) event during the study-specified induction Exclusion Criteria: * Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements * History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing * 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 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 antidrug conjugate (ADC) * Received radiation therapy to the lung that is \>30 Gray within 6 months of start of study intervention * 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 * 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 CYP3A4 that cannot be discontinued for the duration of the study (the required washout period before starting sac-TMT is 2 weeks) * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. * Has known central nervous system (CNS) metastases/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) * Has a history of (noninfectious)pneumonitis/ILD that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening * Active infection requiring systemic therapy * History of allogeneic tissue/solid organ transplant

Study sites (22)

AR

CA

CO

DC

FL

GA

IL

MI

MN

NJ

NM

PA

TX