A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer
- Conditions
- Non-Small Cell Lung Cancer
- Registration Number
- NCT03800134
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 826
Inclusion Criteria:<br><br> - Age =18 years<br><br> - Newly diagnosed and previously untreated patients with histologically or<br> cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage<br> IIIB) disease<br><br> - World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment<br><br> - At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target<br> Lesion (TL) at baseline<br><br> - No prior exposure to immune-mediated therapy including, but not limited to, other<br> anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic<br> anticancer vaccines<br><br> - Adequate organ and marrow function<br><br> - Confirmation of a patient's tumour PD-L1 status<br><br> - Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR<br> and ALK status<br><br> - Planned surgery must comprise lobectomy, sleeve resection, or bilobectomy<br><br>Exclusion Criteria:<br><br> - History of allogeneic organ transplantation<br><br> - Active or prior documented autoimmune or inflammatory disorders (including<br> inflammatory bowel disease, diverticulitis, systemic lupus erythematosus,<br> Sarcoidosis syndrome, or Wegener syndrome)<br><br> - History of another primary malignancy<br><br> - History of active primary immunodeficiency<br><br> - Active infection including tuberculosis hepatitis B and C, or human immunodeficiency<br> virus<br><br> - Deemed unresectable NSCLC by multidisciplinary evaluation<br><br> - Patients who have pre-operative radiotherapy treatment as part of their care plan<br><br> - Patients who have brain metastases or spinal cord compression<br><br> - Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC<br><br> - Known allergy or hypersensitivity to any of the study drugs or excipients<br><br> - Existence of more than one primary tumour such as mixed small cell and NSCLC<br> histology<br><br> - Patients whose planned surgery at enrollment includes any of the following<br> procedures: pneumonectomy, segmentectomies, or wedge resections<br><br> - Patients with a documented test result confirming the presence of EGFRm or ALK<br> translocation
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological Complete Response (pCR) in modified intent-to-treat (mITT) population;Event-Free Survival (EFS) in modified intent to treat (mITT) population
- Secondary Outcome Measures
Name Time Method