Clinical trial · Interventional
A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients
A Phase III, Randomised,Double-Blind,Placebo-Controlled,Study of Durvalumab as Consolidation Therapy in Patients With Locally Advanced,Unresectable NSCLC, Who Have Not Progressed Following Definitive, Platinum-Based Chemoradiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Durvalumab Therapy
- description
- Durvalumab (PD-L1 monoclonal antibody)1500 mg every 4 weeks \[q4w\] intravenously \[iv\] until clinical progression/deterioration or confirmed radiological progression)
- interventionNames
- Drug: Durvalumab
- type
- PLACEBO_COMPARATOR
- label
- Placebo Therapy
- description
- Placebo (matching placebo for infusion every 4 weeks iv until clinical progression/deterioration or confirmed radiological progression)
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS) (Modified Intent-to-Treat [mITT] Set)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDWu YL, Wu L, Bi N, Cil T, Ge H, Zhu Z, Wang CL, Zhang W, Lv D, Mingyan E, Sun J, Pan Y, Krzakowski M, Dikilitas M, Sendur MAN, Kim YC, Yang Y, Mao R, Zhang B, Wang L. PACIFIC-5: a phase III clinical trial of consolidation durvalumab in patients with unresectable stage III NSCLC and no progression after concurrent or sequential chemoradiotherapy. J Hematol Oncol. 2025 Dec 7;18(1):111. doi: 10.1186/s13045-025-01768-1. PMID 41354932