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Clinical Trials in South Korea / NCT03706690
Active, not recruiting Phase 3

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

NCT03706690 · tracked via the Priya Life Science South Korea 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)

Durvalumab →Placebo

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
No
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)

FacilityCityRegionStatus
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 →

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A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus Recruiting
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations Active, not recruiting
Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer Active, not recruiting
Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT Recruiting

Other trials for the same condition

A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer Active, not recruiting
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib Active, not recruiting
Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012) Active, not recruiting
A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2 Active, not recruiting
A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer 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 South Korea