A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants with Stage III Unresectable NSCLC - PACIFIC-8

Study identifier:D9075C00001

ClinicalTrials.gov identifier:NCT05211895

EudraCT identifier:2021-004327-32

CTIS identifier:2023-506891-28-00

Recruiting

Official Title

A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre, International Study of Durvalumab plus Domvanalimab(AB154) in Participants with Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer Whose Disease has not Progressed Following Definitive Platinum-based Concurrent Chemoradiation Therapy

Medical condition

Non-small Cell Lung Cancer

Phase

Phase 3

Healthy volunteers

Study drug

Durvalumab, Domvanalimab

Sex

All

Estimated Enrollment

860

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 18 Feb 2022

Estimated Primary Completion Date: 27 Jun 2028

Estimated Study Completion Date: 30 Aug 2030

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2024 by AstraZeneca

Collaborators

Arcus Biosciences Inc

Inclusion and exclusion criteria

Inclusion Criteria

1. Participant must be ≥ 18 years at the time of screening.
2. Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
3. Provision of a tumour tissue sample obtained prior to CRT
4. Documented tumour PD-L1 status ≥ 1% by central lab
5. Documented EGFR and ALK wild-type status (local or central).
6. Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy
7. Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy
8. Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique.
9. WHO performance status of 0 or 1 at randomization
10.Adequate organ and marrow function

Exclusion Criteria

1. History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease, or adequately treated carcinoma in situ or Ta tumours treated with curative intent and without evidence of disease.
2. Mixed small cell and non-small cell lung cancer histology.
3. Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
4. Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
5. Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy (excluding alopecia).
6. Participants with ≥ grade 2 pneumonitis from prior chemoradiation therapy.
7. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis – regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis
8. Active or prior documented autoimmune or inflammatory disorders (with exceptions)
9. Active EBV infection, or known or suspected chronic active EBV infection at screening
10. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.

Sort by status

No locations available

Arms	Assigned Interventions
Experimental: Arm A: Durvalumab + Domvanalimab Durvalumab and domvanalimab as an IV infusion q4w, starting on Day 1 for up to a maximum of 12 months	Drug: Durvalumab Durvalumab IV (Intravenous infusion) Drug: Domvanalimab Domvanalimab IV (Intravenous infusion)
Active Comparator: Arm B: Durvalumab + Placebo Durvalumab + placebo as an IV infusion q4w starting on Day 1 for up to a maximum of 12 months	Drug: Durvalumab Durvalumab IV (Intravenous infusion) Other: Placebo Placebo IV (Intravenous infusion)

Documents available

1-844-432-3892 Lung Cancer Study Locator details to CT.gov for the US sites only
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Hidehito Horinouchi

National Cancer Center Hospital