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RecruitingLast updated: 4 March 2024

This study is evaluating a new drug (called MK-2870) when given in combination with immunotherapy, compared to immunotherapy alone, in people with metastatic non-small cell lung cancerA Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater Than or Equal to 50%

Clinical summary

Summary

This study is recruiting people with metastatic non-small cell lung cancer with a PD-L1 tumour proportion score (TPS) that is ≥50%.

Eligible participants will be randomly allocated to one of two treatment arms. Treatment cycles in both arms are 6 weeks in length.

In the Experimental Arm, participants will receive a new drug (caleld MK-2870) + pembrolizumab immunotherapy. MK-2870 will be given via intravenous (IV) infusion on Days 1, 15 and 29 of each treatment cycle, and pembrolizumab will be given every 6 weeks (on Day 1 of each cycle) via IV infusion, for 18 cycles.

Additionally, participants receive diphenhydramine (or equivalent), an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to the first 4 infusions of MK-2870. At subsequent infusions, the H2 antagonist and dexamethasone are optional, at the discretion of the investigator.

In the Active Comparator Arm, participants will receive pembrolizumab immunotherapy. Pembrolizumab will be given via IV infusion every 6 weeks (on Day 1 of each cycle) for 18 cycles.

Conditions

This trial is treating patients with metastatic non-small cell lung cancer who have not had prior treatment for their metastatic disease

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

III

More information

Trial Identifiers

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Trial sponsor

Merck Sharp & Dohme LLC

Scientific Title

A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater Than or Equal to 50%

Eligibility

Inclusion

  • Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC

    • Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy
    • Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory
    • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.
    • A life expectancy of at least 3 months.
    • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)

Exclusion

  • Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
  • Has Grade ≥2 peripheral neuropathy.
  • History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention.
  • Received prior systemic anticancer therapy for their metastatic NSCLC.
  • Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
  • Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
  • Received radiation therapy to the lung that is >30 Gy 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. Administration of killed vaccines are allowed.
  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Known intolerance to MK-2870 or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary.
  • Known hypersensitivity to MK-2870 or other biologic therapy.
  • Active autoimmune disease that has required systemic treatment in the past 2 years.
  • History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
  • Active infection requiring systemic therapy
  • Concurrent active Hepatitis B and Hepatitis C virus infection.
  • Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
  • History of allogeneic tissue/solid organ transplant.
  • Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study.

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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