Patients with resectable Non-small Cell Lung Cancer (Stage IIA to IIIB
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
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 patients tumour PD-L1 status 8. Provision of sufficient tumor 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
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 tumor 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To compare the efficacy of durvalumab + chemotherapy administered prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy administered prior to surgery followed by placebo post-surgery in terms of EFS - To compare the activity of durvalumab + chemotherapy administered prior to surgery compared with placebo + chemotherapy administered prior to surgery in terms of pCR;Secondary Objective: - To compare the efficacy of perioperative durvalumab + neoadjuvant chemotherapy compared with placebo + neoadjuvant chemotherapy in terms of DFS - To compare the efficacy of perioperative durvalumab + neoadjuvant chemotherapy compared with placebo + neoadjuvant chemotherapy in terms of MPR - To compare the efficacy of perioperative durvalumab + neoadjuvant chemotherapy compared with placebo + neoadjuvant chemotherapy in terms of OS - To compare the efficacy of perioperative durvalumab + neoadjuvant chemotherapy compared with placebo + neoadjuvant chemotherapy in patients with PD-L1 TC =1% tumors in terms of EFS, pCR, DFS, MPR and OS - To assess disease-related symptoms and HRQOL in patients treated with perioperative durvalumab + neoadjuvant chemotherapy compared with placebo + neoadjuvant chemotherapy - To assess the PK and immunogenicity of durvalumab;Primary end point(s): Event-free Survival (EFS) and pathological Complete Response (pCR) in modified intent-to-treat (mITT) ;Timepoint(s) of evaluation of this end point: approximately 7 months after last patient randomized and up to 5.5 years after FSR | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. DFS in the modified resected population 2. mPR (= 10% viable tumor cells in lung primary tumor after complete evaluation in the resected lung cancer specimen 3. OS 4. EFS, pCR, DFS, mPR, OS in the population with PD-L1 TC = 1% 5 Change from baseline in Patient reported outcomes and time to deterioration 6. Concentration of durvalumab 7. Presence of ADAs for durvalumab;Timepoint(s) of evaluation of this end point: approximately 5.5 years after last patient randomized. | — |
Countries
Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, France, Germany, Hungary, India, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Peru, Philippines, Poland, Romania, Russian Federation, Spain, Taiwan, Thailand, Ukraine, United States, Viet Nam
Contacts
Public ContactStudy Information Center
AstraZeneca AB
Outcome results
None listed