A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT03800134

This Phase III study evaluates durvalumab plus chemotherapy versus placebo plus chemotherapy in resectable NSCLC patients. Eligible participants are adults with untreated, resectable Stage IIA-IIIB NSCLC, ECOG PS 0-1, and adequate organ function. Interventions include durvalumab, placebo, carboplatin, cisplatin, pemetrexed, paclitaxel, gemcitabine, and surgery post-neoadjuvant treatment.

Patient Parameters

Program Overview

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.

Eligibility Criteria

Inclusion Criteria

  • Age ≥18 years
  • 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 patient's 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

  • 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

Locations

FACILITYZIPCITYSTATE
Research Site85054PhoenixArizona
Research Site91010DuarteCalifornia
Research Site92868OrangeCalifornia
Research Site80012AuroraColorado
Research Site33486Boca RatonFlorida
Research Site32256JacksonvilleFlorida
Research Site60612ChicagoIllinois
Research Site67214WichitaKansas
Research Site41101AshlandKentucky
Research Site40513LexingtonKentucky

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