Pembrolizumab for Non-Small Cell Lung Cancer

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

Recruiting Phase 2 Interventional Study
Lung Neoplasm Malignant
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Merck Sharp & Dohme LLC · Industry
Who this trial is looking for

This trial is looking for people with certain stages of lung cancer who have not received treatment before. Participants will receive treatment before surgery to see how effective it is in reducing cancer signs.

Are You a Good Fit for This Trial?
Rules you out Severe dry eye syndromeInflammatory bowel diseaseActive autoimmune diseaseSevere peripheral neuropathy

You may be able to join if

  • I have resectable Stage II, IIIA, or IIIB non-small cell lung cancer.
  • I can have surgery as part of the treatment.
  • I have an ECOG performance status of 0 or 1.
  • I can provide a biopsy of my lung tumor or lymph nodes.
  • I do not need EGFR-directed therapy as my primary treatment.

You may not be able to join if

  • I have a tumor located in the superior sulcus or have mixed tumors.
  • I have severe peripheral neuropathy.
  • I have a history of severe dry eye syndrome or related conditions.
  • I have active inflammatory bowel disease or a history of it.
  • I have uncontrolled significant heart or brain blood vessel disease.
  • I received a live vaccine within 30 days before starting the trial.
  • I have a known additional cancer that is active or needs treatment.
  • I have a history of active autoimmune disease requiring treatment.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

The main goals are after treatment given before surgery, to measure the number of people who have no signs of cancer cells in tumors and lymph nodes removed during surgery; and to learn about whether the cancer gets smaller or goes away by measuring the number of people with a certain number of living cancer cells in the tumor removed during surgery.

Trial Locations
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Eligibility Criteria
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * 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 sur…
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