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NCT03706690

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

Last Updated: 2025-11-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

407 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-27

Study Completion Date

2027-02-26

Brief Summary

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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.

Detailed Description

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Approximately 400 patients will be randomized in a 2:1 to receive treatment with durvalumab or placebo therapy. The primary objective of this study is to assess the efficacy of durvalumab treatment compared with placebo in terms of PFS.

Conditions

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Carcinoma, Non-Small-Cell Lung

Keywords

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NSCLC Double-Blind PD-L1 MEDI4736 Durvalumab PFS OS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Sponsor, excluding supply chain management personnel and unblinded monitors of site pharmacies, will remain blinded.

Study Groups

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Durvalumab Therapy

Durvalumab (PD-L1 monoclonal antibody)1500 mg every 4 weeks \[q4w\] intravenously \[iv\] until clinical progression/deterioration or confirmed radiological progression)

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

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

Placebo Therapy

Placebo (matching placebo for infusion every 4 weeks iv until clinical progression/deterioration or confirmed radiological progression)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Durvalumab

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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MEDI4736

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yilong Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Guangdong General Hospital, Guangdong Lung Cancer Institute

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China Hong Kong India Mexico Philippines Poland Russia South Korea Taiwan Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2018-002294-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D933YC00001

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Durvalumab Therapy

Durvalumab

Placebo Therapy

Placebo

Interventions

Durvalumab

Placebo

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

AstraZeneca

Responsible Party

Principal Investigators

Yilong Wu, MD

Locations

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