Back to search results

Pembrolizumab and Chemotherapy for Resectable Lung Cancer

This study is looking at new ways to treat non-small cell lung cancer (NSCLC) that can be removed by surgery. It combines Pembrolizumab, an immunotherapy, with chemotherapy drugs like Cisplatin and either Gemcitabine (for squamous tumors) or Pemetrexed (for non-squamous tumors). Some participants may also receive Sacituzumab tirumotecan. The main goals are to see how many people have no cancer cells left in their tumors after this treatment before surgery, and to measure how much the cancer shrinks. You might be able to join if you have previously untreated, resectable Stage II, IIIA, or IIIB (N2) NSCLC and your cancer does not have an EGFR biomarker that would require a different type of treatment. The study is currently unclear on its recruitment status and plans to enroll about 60 people.

Study design
This is an interventional study with a planned enrollment of 60 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured up to approximately 20 weeks after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06788912

Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)

Recruiting
PHASE2Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~60 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:Pembrolizumab (neoadjuvant)CisplatinGemcitabinePemetrexedSacituzumab tirumotecanH1 receptor antagonist

At a glance

Recruiting sites
39 of 39 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pathological Complete Response (pCR)
Measured over Up to approximately 20 weeks
+1 more outcome measured

Conditions

Lung Neoplasm Malignant

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

39 sites across 27 states
Turkey (Türkiye)5
Region M. de Santiago3
Attica3
Italy3
Maryland2
Texas2
Alabama1
California1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Has previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC)
Able to undergo protocol therapy, including necessary surgery
Confirmation that epidermal growth factor receptor (EGFR) -directed therapy is not indicated as primary therapy
Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 10 days before initiation of study intervention.
Is able to provide archival or newly obtained core/excisional biopsy of the primary lung tumor or lymph node metastasis.

Exclusion

Has one of the following tumor locations/types: NSCLC involving the superior sulcus, large-cell neuro-endocrine cancer, mixed tumors containing small cell and non-small cell elements, or sarcomatoid tumor.
Has Grade ≥2 peripheral neuropathy.
Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
Has 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.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids.
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
Known additional malignancy that is progressing or has required active treatment within the past 5 years.
Severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid) is allowed.
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Active infection requiring systemic therapy.
Hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or Hepatitis C virus (defined as detectable hepatitis C virus (HCV) ribonucleic acid (RNA) \[qualitative\]) infection.
Known history of human immunodeficiency virus (HIV) infection.
History of allogeneic tissue/solid organ transplant.

What this trial measures

  • Pathological Complete Response (pCR)Up to approximately 20 weeks

    pCR is defined as absence of residual viable invasive cancer on hematoxylin- and eosin-stained slides of the resected lung specimen and lymph nodes.

  • Percent Residual Viable Tumor (%RVT)Up to approximately 20 weeks

    %RVT is defined as the percentage of residual tumor estimated by comparing the estimated cross-sectional area of viable tumor with estimated cross-sectional areas of remainder of tumor bed. The tumor bed is defined as the area of tissue occupied by viable tumor or tumoral regression (includes areas of necrosis, foamy macrophages, giant cell reaction, cholesterol cleft granuloma, and inflammation.)