Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT03800134
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC with resectable (Stage IIA to select \[ie, N2\] Stage IIIB) disease
* World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
* At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline
* No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines
* Adequate organ and marrow function
* Confirmation of a patient's tumour PD-L1 status
* Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR and ALK status
* Planned surgery must comprise lobectomy, sleeve resection, or bilobectomy
Exclusion Criteria:
* History of allogeneic organ transplantation
* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome)
* History of another primary malignancy
* History of active primary immunodeficiency
* Active infection including tuberculosis hepatitis B and C, or human immunodeficiency virus
* Deemed unresectable NSCLC by multidisciplinary evaluation
* Patients who have pre-operative radiotherapy treatment as part of their care plan
* Patients who have brain metastases or spinal cord compression
* Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC
* Known allergy or hypersensitivity to any of the study drugs or excipients
* Existence of more than one primary tumour such as mixed small cell and NSCLC histology
* Patients whose planned surgery at enrollment includes any of the following procedures: pneumonectomy, segmentectomies, or wedge resections
* Patients with a documented test result confirming the presence of EGFRm or ALK translocation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT03800134
Study Brief:
Protocol Section:
NCT03800134