What is pembrolizumab studying for advanced non-small cell lung cancer?

Pembrolizumab is being studied to see how adding other treatments like chemotherapy or HER3-DXd affects advanced non-small cell lung cancer. Researchers want to learn about the safety and how well these combinations work. This trial is sponsored by Merck Sharp & Dohme LLC and focuses on treatment-naive patients with stage IV NSCLC.

Who may be eligible for this non-small cell lung cancer clinical trial?

Adults 18 years or older diagnosed with stage IV non-small cell lung cancer who have a good performance status may be eligible. Participants must not have had prior systemic treatment for metastatic NSCLC and need to meet specific health criteria. There is no gender restriction. Please review eligibility criteria for more details.

Is there any cost to participate in this non-small cell lung cancer clinical trial?

Study-related care, including study drugs and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06731907

Phase 2 Study of Pembrolizumab With or Without Chemotherapy and Additional Treatments for Advanced Stage IV Non-Small Cell Lung Cancer

Led by Merck Sharp & Dohme LLC · Updated on 2026-05-26

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating new treatments for advanced non-small cell lung cancer NSCLC that has not been treated before. NSCLC is the most common type of lung cancer and includes cases where the cancer has spread beyond what surgery can remove. The study aims to evaluate the safety and effectiveness of adding new treatments, including a special antibody-drug conjugate called HER3-DXd, to the existing immunotherapy drug pembrolizumab, with or without chemotherapy. This is a Phase 2 randomized study focused on participants with stage IV NSCLC. Participants will be randomly assigned to one of two treatment groups. One group will receive pembrolizumab combined with standard platinum-based chemotherapy, which includes drugs like paclitaxel, nab-paclitaxel, carboplatin, or pemetrexed, given intravenously in cycles every three weeks. The other group will receive pembrolizumab combined with HER3-DXd, also given intravenously every three weeks. Pembrolizumab is given at a fixed dose of 200 mg every three weeks for up to about two years, while chemotherapy and HER3-DXd are administered according to specific dosing schedules and discontinued based on defined criteria. During the study, participants will be monitored for up to five years to assess treatment responses, side effects, and survival outcomes. Researchers will collect tumor tissue samples, track adverse events, and measure overall response rates, progression-free survival, and overall survival. Safety will be closely observed, including the number of participants who stop treatment due to side effects. Participants will have regular visits for infusions and assessments, and the study may last several years depending on individual treatment and follow-up needs.

CONDITIONS

Brief Title

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)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous non-small cell lung cancer (NSCLC) according to AJCC Staging Manual Version 8
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization
Availability of archival tumor tissue or a newly obtained biopsy from a tumor lesion not previously irradiated
HIV-infected participants must have well-controlled HIV on antiretroviral therapy
Hepatitis B surface antigen positive participants must have received antiviral therapy for at least 4 weeks and have undetectable viral load prior to randomization

You will not qualify if you...

Diagnosis of small cell lung cancer or presence of small cell elements in mixed tumors
Squamous histology with known activating EGFR mutation or ALK or ROS1 gene rearrangement
HIV infection with history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Severe pulmonary compromise from other pulmonary illnesses or autoimmune, connective tissue, or inflammatory disorders with lung involvement
Evidence of leptomeningeal disease
Known history of or active neurologic paraneoplastic syndrome
Clinically significant corneal disease
Myocardial infarction within the past 6 months
New York Heart Association (NYHA) class 3 or 4 congestive heart failure
Uncontrolled angina pectoris within 6 months
Cardiac arrhythmias requiring ongoing treatment or history of serious ventricular arrhythmias
Bradycardia less than 50 beats per minute unless pacemaker present
History of second- or third-degree heart block unless pacemaker present without symptoms
Coronary or peripheral artery bypass graft within 6 months
Complete left bundle branch block
Inadequate washout period from prior therapies before randomization
Prior treatment with topoisomerase I inhibitors or anti-HER3 antibodies/ADCs with exatecan derivatives
Prior systemic anticancer therapy for metastatic NSCLC
Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents or other T-cell receptor agents
Radiotherapy within 2 weeks before randomization or radiation pneumonitis
Radiation therapy to the lung exceeding 30 gray within 6 months
Live or live-attenuated vaccine within 30 days before first dose
Immunodeficiency diagnosis or recent immunosuppressive therapy
Additional malignancy requiring active treatment in past 3 years
Active central nervous system metastases or carcinomatous meningitis
Severe hypersensitivity to study interventions or excipients
Active autoimmune disease requiring systemic treatment in past 2 years
Active infection requiring systemic therapy
Concurrent active Hepatitis B and C infections
Incomplete recovery from major surgery or ongoing surgical complications

Research Team

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Phase 2 Study of Pembrolizumab With or Without Chemotherapy and Additional Treatments for Advanced Stage IV Non-Small Cell Lung Cancer

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria