A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients

NCT03706690 · tracked via the Priya Life Science India tracker

Sponsor

AstraZeneca

Phase

Phase 3

Started

2018-11-27

Last updated

2026-08-06

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

DurvalumabPlacebo

Durvalumab: Durvalumab 1500 mg every 4 weeks \[q4w\] intravenously \[iv\] until clinical progression/ deterioration or confirmed radiological progression.

Placebo: Matching placebo for infusion every 4 weeks iv until clinical progression/deterioration or confirmed radiological progression

Study summary

This is a Phase III, randomised, double-blind, placebo-controlled, multicentre study assessing the efficacy and safety of durvalumab compared with placebo, as consolidation therapy in patients with locally advanced, unresectable, non-small cell lung cancer (Stage III), who have not progressed following definitive, platinum-based, chemoradiation therapy.

Eligibility

Sex

ALL

Min age

18 Years

Max age

130 Years

Healthy volunteers

Inclusion Criteria: 1. Age≥18 years 2. Documented NSCLC and present with locally advanced, unresectable (Stage III) disease; 3. Receipt of concurrent or sequential chemoradiation therapy, 4. No progression following definitive, platinum-based, concurrent or sequential chemoradiation therapy 5. World Health Organization (WHO) PS of 0 or 1; 6. No prior exposure to any anti CTLA-4, anti-PD-1, anti-PD-L1, or anti PD L2 antibodies, excluding therapeutic anticancer vaccines 7. Adequate organ and marrow function required 8. Life expectancy of at least 12 weeks 9. Tumor PD-L1 status, with the Ventana SP263 PD-L1 IHC assay determined by a reference laboratory, must be known prior to randomization. 10. Tumour sample requirements are as follows: Provision of a tumour tissue sample (newly acquired sample \<=3 months old is preferred, but an archived sample \<=6 months old is acceptable) in a quantity sufficient to allow for analysis. Exclusion Criteria: 1. History of allogeneic organ transplantation, or another primary malignancy, or active primary immunodeficiency. 2. Active or prior documented autoimmune or inflammatory disorders 3. Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent 4. Active infection including tuberculosis hepatitis B hepatitis C (HCV), or human immunodeficiency virus (positive human immunodeficiency virus \[HIV\] 1/2 antibodies). 5. Mixed small cell and NSCLC histology, sarcomatoid variant 6. Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 from the prior chemoradiation therapy. 7. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. 8. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.

Primary outcome measure(s)

Progression-Free Survival (PFS) (Modified Intent-to-Treat [mITT] Set) — Tumor scans performed at screening, every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days)
The PFS per Response Evaluation Criteria in Solid Tumors 1.1. (RECIST 1.1) using blinded independent central review (BICR) assessments was defined as the time from the date of randomization until the date of objective disease progression (PD) or death (by any cause in the absence of progression) regardless of whether the participant withdrew from therapy or received another anti-cancer therapy prior to progression. The PD was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of \>=5 millimeters (mm), taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique.

Trial sites (87)

Facility	City	Region
Research Site	Beijing	China
Research Site	Beijing	China
Research Site	Beijing	China
Research Site	Beijing	China
Research Site	Bengbu	China
Research Site	Changchun	China
Research Site	Changchun	China
Research Site	Changsha	China
Research Site	Chengdu	China
Research Site	Chengdu	China
Research Site	Chengdu	China
Research Site	Chongqing	China
Research Site	Fuzhou	China
Research Site	Guangzhou	China
Research Site	Hangzhou	China
Research Site	Hangzhou	China
Research Site	Hangzhou	China
Research Site	Harbin	China
Research Site	Linhai	China
Research Site	Nanjing	China
Research Site	Nanning	China
Research Site	Ningbo	China
Research Site	Qingdao	China
Research Site	Shanghai	China
Research Site	Shanghai	China
Research Site	Shanghai	China
Research Site	Shenyang	China
Research Site	Ürümqi	China
Research Site	Wenzhou	China
Research Site	Wuhan	China
Research Site	Yangzhou	China
Research Site	Zhengzhou	China
Research Site	Zhengzhou	China
Research Site	Hong Kong	Hong Kong
Research Site	Bangalore	India
Research Site	Bengaluru	India
Research Site	Karamsad	India
Research Site	Kolkata	India
Research Site	Nashik	India
Research Site	Vadodara	India

+ 47 more sites — see the full list on the official registry below.

On this site

📄 Imfinzi (durvalumab) drug profile →

More AstraZeneca trials in India

Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) Active, not recruiting

A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin Recruiting

Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) Active, not recruiting

A Study to Identify and Characterize Patients With Type 2 Diabetes Mellitus for Possible Participation in Ongoing or Future Type 2 Diabetes Mellitus Clinical Studies Recruiting

Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen Recruiting

Other trials for the same condition

A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC Active, not recruiting

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions Active, not recruiting

A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3) Active, not recruiting

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure Active, not recruiting

A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03706690 on ClinicalTrials.gov ↗ ← All trials in India