Patients with resectable Non-small Cell Lung Cancer (Stage IIA to IIIB
Conditions
Interventions
Product Name: durvalumab
Product Code: MEDI4736
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: durvalumab
CAS Number: 1428935-60-7
Current Sponsor code: MEDI4736
Conce
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 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
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.
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 efficacy of durvalumab + chemo administered prior to surgery compared with placebo + chemo administered prior to surgery in terms of DFS - To compare the activity of durvalumab + chemotherapy administered prior to surgery compared with placebo + chemotherapy administered prior to surgery in terms of mPR - To compare efficacy of durvalumab + chemo administered prior to surgery followed by durvalumab post-surgery compared with placebo + chemo administered prior to surgery followed by placebo after surgery in terms of OS, as well as in patients with PD-L1 TC greater or equal to 1% in terms of EFS, pCR, DFS, mpR and OS - To assess disease-related symptoms and Health-Related Quality of Life (HRQoL) in patients treated with durvalumab + chemo administered prior to surgery followed by durvalumab post-surgery compared with placebo + chemo administered prior to surgery followed by placebo post-surgery - To assess the pharmacokinetics (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 6 months after last patient randomized | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. DFS in the modified resected population 2. mPR (=10% viable tumour cells in lung primary tumour 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 has had surgery. | — |
Countries
Argentina, Austria, Belgium, Bulgaria, Chile, France, Germany, Hungary, India, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Philippines, Poland, Romania, Russian Federation, Spain, Taiwan, Thailand, Ukraine, United States, Viet Nam
Contacts
Public ContactStudy Information Center
AstraZeneca AB
Outcome results
None listed