TroFuse-007

A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater than or Equal to 50%

Participants are eligible to be included in the study only if all of the following criteria apply:

• Newly diagnosed, untreated, stage IV nonsquamous and squamous NSCLC
• ECOG 0 to 1
• PD-L1 TPS ≥ 50%
• No EGFR/ALK/ROS1 aberrations in nonsquamous NSCLC
• No pneumonitis or interstitial lung disease

Participants are excluded from the study if any of the following criteria apply:

1. Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
2. Has Grade ≥2 peripheral neuropathy.
3. History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
4. Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea).
5. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention
6. Received prior systemic anticancer therapy for their metastatic NSCLC.
Note: Prior treatment with chemotherapy and/or radiation as part of neoadjuvant or adjuvant therapy or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
7. Received radiation therapy to the lung that is >30 Gy within 6 months of start of study intervention.
8. Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention.