Non-Small Cell Lung Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Durvalumab, Carboplatin/Paclitaxel, Cisplatin/Gemcitabine, Pemetrexed/Cisplatin, Pemetrexed/Carboplatin
INN of investigational material : -
Therapeutic c
Sponsors
AstraZeneca KK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease - World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment - At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline - 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 - Adequate organ and marrow function - Confirmation of a patients tumour PD-L1 status - Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR and ALK status - Planned surgery must comprise lobectomy, sleeve resection, or bilobectomy
Exclusion criteria
Exclusion criteria: - History of allogeneic organ transplantation - Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome) - History of another primary malignancy - History of active primary immunodeficiency - Active infection including tuberculosis hepatitis B and C, or human immunodeficiency virus - Deemed unresectable NSCLC by multidisciplinary evaluation Patients who have pre-operative radiotherapy treatment as part of their care plan - Patients who have brain metastases or spinal cord compression - Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC - Known allergy or hypersensitivity to any of the study drugs or excipients - Existence of more than one primary tumour such as mixed small cell and NSCLC histology - Patients whose planned surgery at enrollment includes any of the following procedures: pneumonectomy, segmentectomies, or wedge resections - Patients with a documented test result confirming the presence of EGFRm or ALK translocation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy pharmacogenomics Pathological complete response (pCR) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy bioequivalence confirmatory exploratory pharmacokinetics pharmacodynamics pharmacogenomics other 1. Disease-free survival (DFS) in modified resected population 2. Major Pathological Response (mPR) 3. Overall Survival (OS) 4. Event-free survival (EFS) in PD-L1-TC 1% or more positive patients 5. pCR in PD-L1-TC 1% or more positive patients 6. Disease-Free Survival (DFS) in PD-L1-TC 1% or more positive patients 7. Major Pathological Response (mPR) in PD-L1-TC 1% or more positive patients 8. Overall Survival (OS) in PD-L1-TC 1% or more positive patients 9. To assess disease-related symptoms and HRQoL (EORTC QLQ-C30) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery 10. To assess disease-related symptoms and HRQoL (EORTC QLQ-LC13) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery 11. To assess the PK of durvalumab in blood (through concentration) 12. Presence of ADA for durvalumab | — |
Countries
Europe, Japan, North America, South America
Outcome results
None listed