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

  • STATUS
    Recruiting
  • End date
    Apr 30, 2024
  • participants needed
    800
  • sponsor
    AstraZeneca
Updated on 26 September 2021
Investigator
AstraZeneca Clinical Study Information Center
Primary Contact
Research Site (4.8 mi away) Contact
+320 other location
paclitaxel
pemetrexed
carboplatin
gemcitabine
EGFR
durvalumab
cancer chemotherapy
carboplatin/paclitaxel
lung carcinoma

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.

Details
Condition Non-Small Cell Lung Cancer, nsclc
Treatment Placebo, durvalumab, Pemetrexed/cisplatin, Carboplatin/Paclitaxel, Cisplatin/Gemcitabine, Pemetrexed/Carboplatin
Clinical Study IdentifierNCT03800134
SponsorAstraZeneca
Last Modified on26 September 2021

Eligibility

Yes No Not Sure

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
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