Durvalumab/Osimertinib + SBRT for Lung Cancer

(PACIFIC-4 Trial)

Recruiting at 195 trial locations

Overseen By AstraZeneca Lung Cancer Study Locator Service

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 with early-stage, unresected non-small cell lung cancer without lymph node involvement. Participants must weigh more than 30 kg and have good organ function. Those with certain EGFR mutations can join an additional cohort. Contraception is required during the study.

Inclusion Criteria

I can take care of myself and perform daily activities.

I have had lung cancer more than once or at the same time, with some exceptions.

You are expected to live for at least 12 more weeks.

Exclusion Criteria

Your heart's electrical activity is too slow, as shown by multiple ECG tests.

I have previously received EGFR TKI therapy before or after surgery.

My cancer does not have the EGFR mutation according to tests.

Treatment Details

Interventions

• Durvalumab (Checkpoint Inhibitor)
• Osimertinib (Tyrosine Kinase Inhibitor)
• Placebo (Other)
• SBRT (Radiation)

Trial Overview The trial tests if durvalumab combined with standard-of-care stereotactic body radiation therapy (SBRT) improves outcomes compared to placebo plus SBRT in one group, while another group receives osimertinib following SBRT if they have specific EGFR mutations.

Participant Groups

Group I: SoC SBRT + Osimertinib Therapy (Osimertinib cohort, single-arm, open-label separate cohort) Experimental Treatment 1 Intervention

SBRT Osimertinib 80mg every day \[qd\] for oral administration up to 36 months or until progression. Osimertinib treatment should start within 7 to 14 days after completion of SBRT

Group II: SoC SBRT + Durvalumab Therapy (Main Cohort) Experimental Treatment 1 Intervention

SBRT Durvalumab (PD-L1 monoclonal antibody) 1500 mg every 4 weeks \[q4w\] intravenously \[iv\] for up to 26 cycles or until progression or other discontinuation criteria are met.

Group III: SoC SBRT + Placebo Therapy (Main Cohort) Placebo Group 1 Intervention

SBRT Placebo (matching placebo for infusion) every 4 weeks iv for up to 26 cycles or until progression or other discontinuation criteria are met.

Durvalumab is already approved in Japan for the following indications:

Approved in Japan as Imfinzi for:

• Not specified in provided sources

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology