RecruitingPhase 2

A Study of Pembrolizumab With or Without Chemotherapy in Combination With Additional Treatments for Advanced Non-Small Cell Lung Cancer (NSCLC) (MK-3475-01G/KEYMAKER U01)

KEYMAKER-U01 Substudy 01G: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents in Combination With Pembrolizumab With or Without Platinum-based Chemotherapy in Treatment-Naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)

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 chemotherapy, plus other treatments such as patritumab deruxtecan. It checks how safe these treatments are and how well they work. It is for people with advanced non-small cell lung cancer who have not had treatment for their cancer after it spread.

Researchers are investigating new treatments for untreated advanced non-small cell lung cancer (NSCLC), which is the most common form of lung cancer and lung cancer that has spread beyond surgical removal. Standard treatments include immunotherapy, such as pembrolizumab, and chemotherapy. This study aims to determine the effectiveness of adding other treatments, including the human epidermal growth factor receptor 3-directed antibody-drug conjugate (HER3-DXd) patritumab deruxtecan, to pembrolizumab, with or without chemotherapy. The primary goals are to assess safety and efficacy of the treatments.

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 IV non-small cell lung cancer, confirmed by testing cells or tissue. Stage IV means the cancer has spread to distant parts of the body.
  • Are fully active or can do light work, even if hard physical activity is difficult.
  • Provide a stored or new tumor tissue sample from an area that has not had radiation.
  • If you have HIV, it must be well controlled with HIV medicines.
  • If you test positive for hepatitis B, you must have taken antiviral medicine for at least 4 weeks, with no virus detected in your blood before treatment assignment.

Who can't join

  • Have small cell lung cancer, including a mixed tumor with small cell cancer; or have the squamous type of NSCLC with certain EGFR, ALK, or ROS1 gene changes.
  • Have severe lung problems; cancer in the tissues around the brain or spinal cord; active cancer spread to the brain or spinal cord; a cancer-related nerve disorder; or serious disease of the clear front layer of the eye.
  • Have certain serious heart or heart rhythm problems, or had a heart attack, uncontrolled chest pain, or heart or limb artery bypass surgery within 6 months. Some people with pacemakers may qualify.
  • Have already had drug treatment for metastatic NSCLC, certain immune treatments, or certain drugs targeting HER3 or an enzyme called topoisomerase I; or have not waited long enough after other treatments.
  • Had radiation within 2 weeks, lung radiation above 30 gray within 6 months, lung swelling from radiation, or radiation side effects needing steroids.
  • Have a weak immune system, recently used medicines that weaken it, had a live vaccine within 30 days, or have an autoimmune disease needing whole-body treatment in the past 2 years. Autoimmune disease means the immune system attacks healthy tissue.
  • Have an infection needing whole-body treatment, active hepatitis B and C together, or HIV with a history of Kaposi's sarcoma or Multicentric Castleman's disease.
  • Have another cancer that is growing or needed treatment within 3 years, a severe allergy to a study treatment or its ingredients, or have not healed well after major surgery.

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

Official eligibility criteria

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) Staging Manual Version 8. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 7 days before randomization. * Has 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 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 prior to treatment randomization. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements. * Participants with squamous histology are excluded if there is a known tumor-activating epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) or c ros oncogene 1 (ROS1) gene rearrangement. * Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement. * Has evidence of any leptomeningeal disease. * Has known history of, or active, neurologic paraneoplastic syndrome. * Has clinically significant corneal disease. * Has myocardial infarction within 6 months. * Has New York Heart Association (NYHA) Classes 3 or 4 congestive heart failure. * Has uncontrolled angina pectoris within 6 months. * Has cardiac arrhythmia requiring ongoing antiarrhythmic treatment. * Has history of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes. * Has bradycardia of less than 50 beats per minute (bpm) unless the participant has a pacemaker. * Has history of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers and have no history of fainting or clinically relevant arrhythmia with pacemakers. * Has coronary/peripheral artery bypass graft within 6 months. * Has complete left bundle branch block. * Has inadequate washout period from prior concomitant therapy as specified in protocol before randomization. * Has received prior treatment with a topoisomerase I inhibitor or an anti-HER3 antibody and/or ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor. * Has received prior systemic anticancer therapy for their metastatic NSCLC. * Has received prior therapy with an anti- programmed cell death 1 protein (anti-PD-1), anti- programmed cell death ligand 1 protein (anti-PD-L1), or anti- programmed cell death ligand 2 protein (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor. * Has received prior radiotherapy within 2 weeks of randomization, has radiation related toxicity requiring corticosteroids, or has had radiation pneumonitis. * Has received radiation therapy to the lung that is \>30 gray within 6 months of start of study intervention. * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. * Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention. * Has 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. * Has severe hypersensitivity to any of the study interventions and/or any of their excipients. * Has active autoimmune disease that has required systemic treatment in the past 2 years. * Has active infection requiring systemic therapy. * Has concurrent active Hepatitis B and Hepatitis C virus infection. * Have not adequately recovered from major surgery or have ongoing surgical complications.

Study sites (5)

KY

MD

ND

PA

SD