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A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab with Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) Osimertinib cohort, Open-label, Single arm for patients with unresected stage I/II, lymph negative NSCLC harboring a sensitizing EGFR mutation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512667-31-00
Acronym
D9103C00001
Enrollment
148
Registered
2024-06-06
Start date
2019-04-23
Completion date
Unknown
Last updated
2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lymph done negative NSCLC harboring a sensitizing EGFR mutation, lymph-node negative Non-small Cell Lung Cancer Osimertinib cohort: Open-label, Main cohort: Patients with unresected Stage I/II, Single arm for patients with unresected stage I/II

Brief summary

Applicable to main cohort: PFS in patients with subset of T1 to T3N0M0 by BICR, Applicable to osimertinib cohort: 4-years PFS by ICR using RECIST 1.1

Detailed description

Applicable to main cohort: PFS in patients with T1 to T3N0M0 NSCLC; Overall Survival; PFS24, TTP, and TTDM using BICR assessments according to RECIST 1.1; PFS2 using local assessment; PK of durvalumab in serum; Presence of ADA for durvalumab; EORTC QLQ-C30: Change in symptoms, functioning, and global health status/quality of life; Safety and tolerability:AEs, physical examinations, vital signs, electrocardiograms, and laboratory findings, Applicable to osimertinib cohort: AEs (graded by CTCAE version 5); Laboratory studies: chemistry, hematology, and urinalysis; Clinical evaluations; ECG parametres; LVEF; WHO performance status; PFS using RECIST 1.1; OS; Site(s) of disease progression; Time to CNS progression; TTP; PFS2

Interventions

DRUGTAGRISSO 80 mg film-coated tablets
DRUGINFLIXIMAB
DRUGTAGRISSO 40 mg film-coated tablets
DRUGMYCOPHENOLATE MOFETIL
DRUGGLUCOSE
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Applicable to main cohort: PFS in patients with subset of T1 to T3N0M0 by BICR, Applicable to osimertinib cohort: 4-years PFS by ICR using RECIST 1.1

Secondary

MeasureTime frame
Applicable to main cohort: PFS in patients with T1 to T3N0M0 NSCLC; Overall Survival; PFS24, TTP, and TTDM using BICR assessments according to RECIST 1.1; PFS2 using local assessment; PK of durvalumab in serum; Presence of ADA for durvalumab; EORTC QLQ-C30: Change in symptoms, functioning, and global health status/quality of life; Safety and tolerability:AEs, physical examinations, vital signs, electrocardiograms, and laboratory findings, Applicable to osimertinib cohort: AEs (graded by CTCAE version 5); Laboratory studies: chemistry, hematology, and urinalysis; Clinical evaluations; ECG parametres; LVEF; WHO performance status; PFS using RECIST 1.1; OS; Site(s) of disease progression; Time to CNS progression; TTP; PFS2

Countries

Belgium, France, Germany, Greece, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026