Pembrolizumab and Chemotherapy Neoadjuvant/Adjuvant of NSCLC

Exclusion Criteria

• •1. Have confirmed sensitizing EGFR mutation or ALK alterations. Note: EGFR and ALK testing will be performed in local hospital, and do not need to be sent to the central laboratory.
• •2. A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• •Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication.
• •3. Has one of the following tumor locations/types:
• •* NSCLC involving the superior sulcus
• •* Large cell neuro-endocrine cancer
• •* Sarcomatoid tumor
• •4. Has had an allogenic tissue/solid organ transplant.
• •5. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
• •6. Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy prior to \[allocation\].
• •7. Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
• •8. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
• •Note: please refer to Section 5.5.2 for information on COVID-19 vaccines
• •9. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
• •10. 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 drug.
• •11. Known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.
• •12. Has a known severe hypersensitivity (≥Grade 3) to any of the study chemotherapy agents and/or to any of their excipients.
• •13. Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)
• •14. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
• •15. Has an active infection requiring systemic therapy.
• •16. Has a known history of Human Immunodeficiency Virus (HIV) infection. Note: No HIV testing is required unless mandated by local health authority.
• •17. Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.
• •Note: Hepatitis B and C screening tests are not required unless:
• •* Known history of HBV and HCV infection
• •* As mandated by local health authority
• •18. Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
• •19. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• •20. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
• •21. Participants who have had major surgery within 14 days of first treatment.