Gender
All
Age Group
18 Years to 95 Years
Accepting Healthy Volunteers
No
Inclusion Criteria:
- Newly diagnosed NSCLC patients with resectable disease (Stage IIA to Stage IIIB).
- WHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and bone marrow function.
- Provision of tumour samples (newly acquired or archival tumour tissue [≤ 6 months
old]) to confirm Programmed death-ligand 1 (PD-L1) status, epidermal growth factor
receptor (EGFR), or anaplastic lymphoma kinase (ALK) status.
- Adequate pulmonary function.
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.