study of pembrolizumab/vibostolimab (mk-7684a) in combination with concurrent chemoradiotherapy followed by pembrolizumab/vibostolimab versus concurrent chemoradiotherapy followed by durvalumab in participants with stage iii non-small cell lung cancer (mk-7684a-006)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: researchers are looking for new ways to treat people with locally advanced non-small cell lung cancer (nsclc). the goal of this study is to learn if people who receive the combination of vibostolimab and pembrolizumab (mk-7684a) live longer without the cancer getting worse and live longer overall than people who receive durvalumab.

as of protocol amendment 4, participants receiving combination vibostolimab and pembrolizumab (mk-7684a) discontinued treatment due to lack of efficacy observed in other mk-7684a studies, and are given the option to transition to durvalumab therapy.

Eligibility criteria:
the main inclusion and exclusion criteria include but are not limited to the following: inclusion criteria * has pathologically (histologically or cytologically) confirmed diagnosis of nsclc. * has stage iiia, iiib, or iiic nsclc by american joint committee on cancer version 8 * is determined to have unresectable, stage iii nsclc as documented by a multidisciplinary tumor board or by the treating physician in consultation with a thoracic surgeon * has no evidence of metastatic disease, indicating stage iv nsclc, in whole-body fluorodeoxyglucose (fdg)-positron emission tomography (pet) or fdg-pet/ computed tomography (ct) and ct or magnetic resonance imaging (mri) scans of diagnostic quality of chest, abdomen, pelvis and brain * has measurable disease as defined by recist 1.1, with at least 1 lesion being appropriate for selection as a target lesion, as determined by local site investigator/radiology review * has not received prior treatment (chemotherapy, targeted therapy, or radiotherapy) for their stage iii nsclc * has provided tumor tissue sample (tissue biopsy \[core, incisional, or excisional\]) * has an eastern cooperative oncology group (ecog) performance status of 0 or 1 assessed within 7 days prior to the first administration of study intervention * has a life expectancy of at least 6 months exclusion criteria * has small cell lung cancer (sclc) or tumors with the presence of small cell elements. mixed squamous/nonsquamous tumors are eligible * has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer * has received major surgery (with the exception of replacement of vascular access) within 4 weeks before randomization. if the participant had a major operation, the participant must have recovered adequately from the procedure and/or any complications from the operation before starting study intervention * is expected to require any other form of antineoplastic therapy, while on study * has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor \[g-csf\], granulocyte macrophage colony-stimulating factor \[gm-csf\], or recombinant erythropoietin) within 28 days prior to the first dose of study intervention * has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention * has a 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 medication * has a known additional malignancy that is progressing or has required active treatment within the past 5 years * has an active autoimmune disease that has required systemic treatment in past 2 years * has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * has an active infection requiring systemic therapy * has a known history of human immunodeficiency virus (hiv) infection * has a known history of hepatitis b (defined as hepatitis b surface antigen \[hbsag\] reactive) or known active hepatitis c virus (defined as hcv ribonucleic acid \[rna\] qualitative is detected) infection * has had an allogenic tissue/solid organ transplant pemetrexed-specific criteria: * is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (nsaids), other than an aspirin dose ≤1.3 grams per day, for at least 2 days (5 days for long-acting agents \[for example, piroxicam\]) before, during, and for at least 2 days after administration of pemetrexed * is unable/unwilling to take folic acid, vitamin b12, and dexamethasone

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