NCT03833154: PACIFIC-4

Durvalumab With Stereotactic Body Radiation Therapy (SBRT) vs Placebo With SBRT in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients/ Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation

Active, enrolled Phase 3 Last updated 26 January 2026

What this trial tests

Phase 3 trial testing Durvalumab in Carcinoma, Non-Small-Cell Lung in 724 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

6 March 2019

Primary endpoint
31 October 2028

31 October 2028

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	724
Start date	6 March 2019
Primary completion	31 October 2028
Estimated completion	31 October 2028
Sites	209 locations across Italy, Japan, Poland, South Korea, Netherlands, Russia, Belgium, United States

Drugs / interventions tested

• Durvalumab — full drug profile →
• Placebo
• (Osimertinib cohort, single-arm, open-label separate cohort) — full drug profile →

Conditions studied

• Carcinoma, Non-Small-Cell Lung — all drugs for Carcinoma, Non-Small-Cell Lung →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 130, any sex, with Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC.

An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Lung cancer immunotherapy: progress, pitfalls, and promises.
   Lahiri A, Maji A, Potdar PD, Singh N, et al · · 2023 · cited 737× · PMID 36810079 · DOI 10.1186/s12943-023-01740-y
2. Type I interferon-mediated tumor immunity and its role in immunotherapy.
   Yu R, Zhu B, Chen D. · · 2022 · cited 229× · PMID 35292881 · DOI 10.1007/s00018-022-04219-z
3. Stereotactic ablative radiotherapy for operable stage I non-small-cell lung cancer (revised STARS): long-term results of a single-arm, prospective trial with prespecified comparison to surgery.
   Chang JY, Mehran RJ, Feng L, Verma V, et al · · 2021 · cited 229× · PMID 34529930 · DOI 10.1016/s1470-2045(21)00401-0
4. Stereotactic ablative radiotherapy with or without immunotherapy for early-stage or isolated lung parenchymal recurrent node-negative non-small-cell lung cancer: an open-label, randomised, phase 2 trial.
   Chang JY, Lin SH, Dong W, Liao Z, et al · · 2023 · cited 165× · PMID 37478883 · DOI 10.1016/s0140-6736(23)01384-3
5. SBRT combined with PD-1/PD-L1 inhibitors in NSCLC treatment: a focus on the mechanisms, advances, and future challenges.
   Chen Y, Gao M, Huang Z, Yu J, et al · · 2020 · cited 125× · PMID 32723363 · DOI 10.1186/s13045-020-00940-z
6. The Abscopal Effect: A Review of Pre-Clinical and Clinical Advances.
   Janopaul-Naylor JR, Shen Y, Qian DC, Buchwald ZS. · · 2021 · cited 118× · PMID 34681719 · DOI 10.3390/ijms222011061
7. Combined treatment of non-small cell lung cancer using radiotherapy and immunotherapy: challenges and updates.
   Shang S, Liu J, Verma V, Wu M, et al · · 2021 · cited 68× · PMID 34658186 · DOI 10.1002/cac2.12226
8. Radiotherapy and immunology.
   Wang L, Lynch C, Pitroda SP, Piffkó A, et al · · 2024 · cited 64× · PMID 38771260 · DOI 10.1084/jem.20232101