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Study of Durvalumab Given With Chemoradiation Therapy in Patients With Unresectable Non-small Cell Lung Cancer
Study of Durvalumab Given With Chemoradiation Therapy in Patients With Unresectable Non-small Cell Lung Cancer

NCT03519971

CompletedPhase 3

Sponsor: AstraZeneca

Conditions: Non-Small Cell Lung Cancer

Interventions: Durvalumab, Placebo, Cisplatin/ Etoposide, Carboplatin/ Paclitaxel, Pemetrexed/ Cisplatin

Countries: Brazil, Czechia, Hungary, India, Japan, Mexico, Peru, Philippines

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, international study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + standard of care \[SoC\] CRT) in patients with locally advanced, unresectable NSCLC (Stage III).

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Principal inclusion criteria :

* Subjects with histologically- or cytologically-documented NSCLC
* Locally advanced, unresectable (Stage III) NSCLC
* World Health Organisation (WHO) performance status 0-1
* At least one measurable lesion, not previously irradiated
* Must have a life expectancy of at least 12 weeks at randomization

Principal exclusion criteria :

* Receipt of prior or current cancer treatment, including but not limited to, radiation therapy, investigational agents, chemotherapy, Durvalumab and mAbs.
* 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.
* History of allogeneic organ transplantation
* Active or prior documented autoimmune or inflammatory disorders
* Uncontrolled intercurrent illness
* History of another primary malignancy / leptomeningeal carcinomatosis / active primary immunodeficiency
* Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus
* Mixed small cell and NSCLC histology
* Any medical contraindication to treatment with platinum-based doublet chemotherapy as listed in the local labelling
* Known allergy or hypersensitivity to any of the IPs or any of the IP excipients.
* Patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving ≥20 Gy in total (V20) of more than 35% of lung volume.
Locations (86)
  • Barretos, Brazil
  • Curitiba, Brazil
  • Florianópolis, Brazil
  • Fortaleza, Brazil
  • Porto Alegre, Brazil
  • Porto Alegre, Brazil
  • Porto Alegre, Brazil
  • Ribeirão Preto, Brazil
  • Ribeirão Preto, Brazil
  • São José do Rio Preto, Brazil
  • São Paulo, Brazil
  • Brno, Czechia
  • Ostrava, Czechia
  • Prague, Czechia
  • Budapest, Hungary
  • Budapest, Hungary
  • Győr, Hungary
  • Gyula, Hungary
  • Törökbálint, Hungary
  • Bangalore, India
  • Chennai, India
  • Gurgaon, India
  • Karamsad, India
  • Mumbai, India
  • Nashik, India
  • New Delhi, India
  • Vadodara, India
  • Bunkyō City, Japan
  • Fukuoka, Japan
  • Kōtoku, Japan
  • + 56 more on CT.gov