A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2024-04-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Carboplatin; Cisplatin; Durvalumab; Gemcitabine; Paclitaxel; Pemetrexed

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