A Study of Durvalumab Before and After Surgery for Patients with Operable 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-DE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• 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 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 520

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 pre-operative 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