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

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 major pathological response.

Primary Outcome Measures

  • Major Pathological Response (mPR) [ Time Frame: From screening pathology to an average of 15 weeks after first dose. ]

Secondary Outcome Measures

  • Pathological complete response (pCR) [ Time Frame: From screening pathology to an average of 15 weeks after first dose. ]
  • Overall Survival (OS) [ Time Frame: From date of randomization to 5.5 years after randomization ]
  • Event-free survival (EFS) [ Time Frame: From date of randomization to 5.5 years after randomization ]
  • Disease-free survival (DFS) [ Time Frame: From date of randomization to 5.5 years after date or resection ]
  • 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 [ Time Frame: From date of screening to 6 months after last dose of IP ]
  • To assess the PK of durvalumab in blood (through concentration) [ Time Frame: From date of randomization to 2 months after resection ]
  • Presence of ADA for durvalumab [ Time Frame: From date of randomization to 3 months after last dose of IP ]
  • mPR in PD-L1-TC positive patients [ Time Frame: From screening pathology to an average of 15 weeks after first dose ]
  • 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 [ Time Frame: From date of screening to 6 months after last dose of IP ]
Inclusion Criteria
Age ≥18 years

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

Documented EGFR and ALK status
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, 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

Mixed small cell and NSCLC histology

Patients who are candidates to undergo only segmentectomies or wedge resections

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Source: the U.S. National Institutes of Health via ClinicalTrials.gov. Last updated: February 1st, 2019.

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Last update: January 19, 2018. 04:57:31 pm.