pembrolizumab (mk-3475) plus investigational agents in resectable non-small cell lung cancer (nsclc) (mk-3475-01e/keymaker-u01)

Conditions: Lung Neoplasm Malignant

Summary: 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:
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 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 criteria: * 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 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.

Keywords: programmed cell death-1 (pd1, pd-1) programmed cell death 1 ligand 1(pdl1, pd-l1) programmed cell death 1 ligand 2 (pdl2, pd-l2)