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

Phase 1

• Conditions: Patients with resectable Non-small Cell Lung Cancer (Stage IIA to IIIB; either squamous or non-squamous); MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-002997-29-BG
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-08
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

1. Age =18 years
2. Newly diagnosed and previously untreated patients with histologically
or cytologically documented NSCLC with resectable (Stage IIA to select
[ie, N2] Stage IIIB) disease
3. World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
4. At least 1 lesion, not previously irradiated, that qualifies as a RECIST
1.1 Target Lesion (TL) at baseline
5. 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.
6. Adequate organ and marrow function
7. Confirmation of a patient's tumour PD-L1 status
8. Provision of sufficient tumour biopsy sample for evaluation and
confirmation of EGFR and ALK status
9. Planned surgery to be performed need to include lobectomy, sleeve
resection or bilobectomy.
10. A pre- or post-bronchodilator FEV of 1.0 L and >40% post-operative
predicted value.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 195

Exclusion Criteria

1. History of allogeneic organ transplantation
2. Active or prior documented autoimmune or inflammatory disorders
(including inflammatory bowel disease, diverticulitis, systemic lupus
erythematosus, Sarcoidosis syndrome, or Wegener syndrome).
3. History of another primary malignancy
4. History of active primary immunodeficiency
5. Active infection including tuberculosis hepatitis B and C, or human
immunodeficiency virus
6. Deemed unresectable NSCLC by multidisciplinary evaluation
7. Patients who have preoperative radiotherapy treatment as part of
their care plan
8. Patients who have brain metastases or spinal cord compression
9. Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC
10. Known allergy or hypersensitivity to any of the study drugs or
excipients
11. Existence of more than one primary tumour such as mixed small cell
and NSCLC histology
12. Patients who are candidates to undergo only pneumonectomy,
segmentectomies or wedge resections.
13. Patients with a documented test result confirming the presence of
EGFRm or ALK translocation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified