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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Pembrolizumab (neoadjuvant)
  • Cisplatin
  • Gemcitabine
  • Pemetrexed
  • Sacituzumab tirumotecan
  • H1 receptor antagonist
  • H2 receptor antagonist
  • Acetaminophen (or equivalent)
  • Dexamethasone (or equivalent)
  • Carboplatin
  • Pembrolizumab (adjuvant)
  • Paclitaxel
  • Steroid mouthwash (dexamethasone or equivalent)

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators