Status:
ACTIVE_NOT_RECRUITING
A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE3
Brief 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 pl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2028
Estimated Enrollment :
825 Patients enrolled
Trial Details
Trial ID
NCT03800134
Start Date
December 6 2018
End Date
September 11 2028
Last Update
June 11 2025
Active Locations (231)
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1
Research Site
Phoenix, Arizona, United States, 85054
2
Research Site
Duarte, California, United States, 91010
3
Research Site
Orange, California, United States, 92868
4
Research Site
Aurora, Colorado, United States, 80012