Comparing sac-TMT with Pembrolizumab for non-small cell lung cancer

Exclusion

• −Severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients or to another biologic therapy
• −HIV-infected participants who have been newly diagnosed or with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• −Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
• −History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
• −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 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 other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention
• −Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T lymphocyte-associated protein 4, OX-40, CD137). Note: Prior treatment with an anti-PD-1 or anti-PD-L1 agent for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC
• −Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antidrug conjugate (ADC)
• −Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
• −Received prior treatment with a topoisomerase I inhibitor-containing ADC
• −Is currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of the study (the required washout periodWashout periodA gap with no treatment, so the previous one clears your system.Read more → before starting sac-TMT is 2 weeks)
• −Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
• −Has known central nervous system (CNS) metastases/carcinomatous meningitis
• −Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapy \[eg, thyroxine, insulin, or physiologic corticosteroid\] is allowed)
• −Has a history of (noninfectious)pneumonitis/ILD that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →
• −Active infection requiring systemic therapy
• −History of allogeneic tissue/solid organ transplant
• −Received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC. Note: Prior treatment with chemotherapy and/or radiation as a 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
• −Received radiation therapy to the lung that is \>30 Gray within 6 months of start of study intervention
• −Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
• −Participants who have not adequately recovered from major surgery or have ongoing surgical complications