a study of skb264 (mk-2870; sac-tmt) for the treatment of participants with advanced or metastatic non-small cell lung cancer (skb264-ii-04) (mk-2870-003)

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the safety, tolerability and objective response rate of skb264 as combination with therapy in subjects with advanced or metastatic non-small cell lung cancer.

this is a multicenter, open-label study of skb264 as combination therapy or monotherapy in subjects with nsclc. approximately 498 subjects will be enrolled in this study including around 88 subjects for the safety run-in period and 410 subjects for the expansion period.

Eligibility criteria:
inclusion criteria 1. subjects must be at least 18 years of age on day of signing informed consent, regardless of gender; 2. subjects with histologically or cytologically confirmed locally advanced or metastatic nsclc ; 3. subjects for nsclc should be confirmed to be egfr (epidermal growth factor receptor) wild-type and alk (anaplastic lymphoma kinase) fusion gene negative; or confirmed to harbor egfr mutation; 4. locally advanced or metastatic nsclc subjects without actionable egfr mutations and alk fusion genes, no prior systemic treatment; subjects with egfr mutation, no prior systemic treatment or failed prior egfr-tki (tyrosine kinase inhibitor) treatment; 5. subjects are able to provide tumor blocks or slides before the first dose of study intervention; 6. subject must have at least one radiographically measurable lesion as per response evaluation criteria in solid tumors (recist) v1.1 criteria; 7. subject has an eastern cooperative oncology group (ecog) performance status of either 0 or 1; 8. life expectancy at least 3 months for the subject; 9. adequate organ function; 10. subjects must have recovered from all toxicities led by prior treatment; 11. contraceptive methods used by male and female subjects must comply with contraceptive methods of local regulations for clinical study subjects; 12. subjects should voluntarily participate in the study, sign the icf, and will be able to comply with the protocol-specified visits and relevant procedures. exclusion criteria 1. subjects with mixed sclc histopathological features; 2. subjects with a known history of prior malignancy; 3. subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active central nervous system (cns) metastases; 4. subjects with ≥ grade 2 peripheral neuropathy; 5. subjects who had arteriovenous thromboembolic events, tumor invasion/encasement of vital organs/vessels, risk of esophageal-tracheal/pleural fistula, or current superior vena cava syndrome; 6. subjects with active inflammatory bowel disease or previous clear history of inflammatory bowel disease; 7. subjects who suffer from cardiovascular diseases of clinical significance; 8. subjects with a history of interstitial lung disease (ild)/non-infectious pneumonitis that required steroids; 9. subjects with uncontrolled systemic disease as judged by the investigator; 10. subjects with active autoimmune disease that required systemic treatment in the past 2 years; 11. subjects with active hepatitis b or hepatitis c; 12. subjects with known history of human immunodeficiency virus (hiv) 13. subjects with known active tuberculosis; 14. subjects with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 15. is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study; 16. subjects whose condition deteriorated rapidly, such as severe changes in performance status, during the screening process prior to the first dose of study intervention; 17. subjects with other circumstances that, in the opinion of the investigator, are not appropriate for participation in this study.