Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer - NeoCOAST-2

Exclusion Criteria

• • Participants with sensitising EGFR mutations or ALK translocations.
• • Active or prior documented autoimmune or inflammatory disorders.
• • Uncontrolled intercurrent illness, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active bleeding diseases, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement.
• • History of another primary malignancy.
• • Participants with small-cell lung cancer or mixed small-cell lung cancer.
• • History of active primary immunodeficiency.
• • History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
• • Participants who have preoperative radiotherapy treatment as part of their care plan.
• • Participants who require or may require pneumonectomy, segmentectomies, or wedge resections, as assessed by their surgeon at baseline, to obtain potentially curative resection of primary tumour.
• • QTcF (QT interval corrected by Fridericia’s formula) interval ≥ 470 ms.
• • Any medical contraindication to treatment with chemotherapy as listed in the local labelling.
• • Participants with moderate or severe cardiovascular disease.
• • Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment.
• • Receipt of live attenuated vaccine within 30 days prior to the first dose of study interventions.
• • Prior exposure to approved or investigational immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. Participants who received agents targeting the adenosine pathway, anti-NKG2A, anti-HLA-E agents, and anti-LIF agents are also excluded. Participants who have received previous treatment with a TROP2 targeting ADC or with another ADC containing a chemotherapy agent that inhibits TOP1 activity are also excluded.
• • Current or prior use of immunosuppressive medication within 14 days before the first dose of study interventions.
• • Active or uncontrolled infections including HBA, HBV, HCV, and HIV.