# 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

Source: https://onco.cc/key-papers/paper-nct03706690-j-hematol-oncol-2025/  
OnCo record `paper-nct03706690-j-hematol-oncol-2025` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Published report from the PACIFIC-5 trial registered as NCT03706690, in Journal of hematology & oncology (2025), chosen as the most cited paper whose own text cites the registry id.

## Summary

Background: Consolidation durvalumab following no progression on concurrent chemoradiotherapy (cCRT) is standard of care for unresectable stage III non-small-cell lung cancer (NSCLC). However, in clinical practice many patients receive sequential CRT (sCRT). The PACIFIC-5 trial aimed to evaluate the efficacy and safety of consolidation durvalumab for unresectable stage III NSCLC following no progression on cCRT or sCRT.

Methods: This randomised, double-blind, placebo-controlled, phase III trial enrolled patients aged ≥ 18 years with unresectable stage III NSCLC, regardless of PD-L1 expression or sensitising EGFR or ALK aberrations, without disease progression after cCRT or sCRT. Patients were randomised (2:1) to durvalumab 1500 mg or placebo intravenously every 4 weeks (stratified by tumour PD-L1 expression and prior treatment) until disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was progression-free survival (PFS) by blinded independent central review in the modified intention-to-treat population (mITT). Secondary endpoints included overall survival (OS) in the mITT and safety. The safety analysis set include patients who received at least one dose of study treatment.

Results: Of 407 patients randomised to receive durvalumab (n = 272) or placebo (n = 135), 405 received at least one dose of durvalumab (n = 271) or placebo (n = 134). The mITT comprised 381 patients randomised to durvalumab (n = 252) or placebo (n = 129). Durvalumab showed statistically significant improvement in PFS versus placebo in the mITT (median [95% confidence interval {CI}], 14.0 [10.9-18.0] vs. 6.5 [5.4-13.8] months; hazard ratio [95% CI], 0.75 [0.58-0.99]; p = 0.038). There was a trend toward improved OS with durvalumab versus placebo in the mITT (median [95% CI], 38.3 [28.9-42.8] vs. 32.5 [20.6-40.4] months; hazard ratio [95% CI], 0.87 [0.66-1.17]; p = 0.346 [interim analysis]). Among the safety analysis set, maximum grade 3 or 4 adverse events of any cause occurred in 26.9% (73/271) and 23.9% (32/134) and 1.5% (4/271) and 0% (0/134) had treatment-related adverse events leading to death for durvalumab and placebo, respectively.

Conclusions: PACIFIC-5 met its primary endpoint of improved PFS after either cCRT or sCRT. Follow-up for overall survival is ongoing.

Trial registration: NCT03706690.

Indexed on Europe PMC as PubMed record 41354932 (DOI 10.1186/s13045-025-01768-1). Its abstract cites the registry id NCT03706690, which is how it was matched to this trial; no figure has been checked by an editor.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Tags: europepmc-ingest
- Journal: Journal of hematology & oncology
- Year: 2025
- DOI: 10.1186/s13045-025-01768-1
- Authors: Wu YL, Wu L, Bi N, et al.
- What it means: This is the paper Europe PMC returns for registry id NCT03706690 with the most citations, so it is the natural first reading for anyone following the PACIFIC-5 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
- Caveats: Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.

## Sources

- J Hematol Oncol 2025: https://doi.org/10.1186/s13045-025-01768-1
- PubMed: https://pubmed.ncbi.nlm.nih.gov/41354932/
- Europe PMC: https://europepmc.org/article/MED/41354932
- ClinicalTrials.gov NCT03706690: https://clinicaltrials.gov/study/NCT03706690

## Connected records

- trials: [A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients](https://onco.cc/trials/nct03706690/)
- journals: [Journal of hematology & oncology](https://onco.cc/journals/journal-of-hematology-and-oncology/)

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