Active Not RecruitingPhase 3NCT03800134

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 pathological complete response.

Checked against the public recordLast updated Jun 11, 2025 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 3
U.S. locations231
SponsorAstraZeneca
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
AstraZeneca
Interventions being studied
Drug: Durvalumab; Other: Placebo; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Gemcitabine; Procedure: Surgery
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SitePhoenix, Arizona
  • Research SiteDuarte, California
  • Research SiteOrange, California
  • Research SiteAurora, Colorado
  • Research SiteBoca Raton, Florida
  • Research SiteJacksonville, Florida
  • Research SiteChicago, Illinois
  • Research SiteWichita, Kansas
  • Research SiteAshland, Kentucky
  • Research SiteLexington, Kentucky
  • Research SiteSilver Spring, Maryland
  • Research SiteTowson, Maryland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 11, 2025. Always confirm current availability with the study team.

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