AEGEA

Phase 3

Completed

• Conditions: on-Small Cell Lung Cancer

• Registration Number: JPRN-jRCT2080224587
• Lead Sponsor: AstraZeneca KK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

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 patients 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>pharmacogenomics<br>Pathological complete response (pCR)