2023-503999-24-00RecruitingPhase 3
A Phase III, double-blind, placebo-controlled, Randomized, Multicenter, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy (PACIFIC-9)
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- AstraZeneca AB
- Enrollment
- 437
- Locations
- 51
- Primary Endpoint
- Progression Free Survival (PFS) as assessed by BICR, per RECIST 1.1. Up to 5 years after first patient randomized.
Study Overview
Brief Summary
"1. To demonstrate superiority of durvalumab + oleclumab relative to durvalumab + placebo in participants with unresectable, Stage III NSCLC who have not progressed on prior platinum-based cCRT •Assessment by PFS as assessed by BICR 2. To demonstrate superiority of durvalumab + monalizumab relative to durvalumab + placebo in participants with unresectable, Stage III NSCLC who have not progressed on prior platinum-based cCRT •Assessment by PFS as assessed by BICR"
Study Design
- Allocation
- Randomized
- Primary Purpose
- Post-Treatment Follow up
- Masking
- Double (Investigator, Monitor, Carer, Subject, Analyst)
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •"•Participant must be ≥ 18 years at the time of screening. •Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease •Provision of a tumour tissue sample obtained prior to CRT •Documented tumour PD-L1 status by central lab •Documented EGFR and ALK wild-type status (local or central). •Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy •Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy •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. •WHO performance status of 0 or 1 at randomization •Adequate organ and marrow function"
Exclusion Criteria
- •"•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, adequately resected non-melanoma skin cancer and curatively treated in situ disease, or adequately treated carcinoma in situ or Ta tumours without evidence of disease. •Mixed small cell and non-small cell lung cancer histology. •Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC. •Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT. •Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy (excluding alopecia). •Participants with ≥grade 2 pneumonitis from prior chemoradiation therapy. •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 - diagnosed in the past 6 months prior to randomization. •Active or prior documented autoimmune or inflammatory disorders (with exceptions) •Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab."
Outcomes
Primary Outcomes
Progression Free Survival (PFS) as assessed by BICR, per RECIST 1.1. Up to 5 years after first patient randomized.
Progression Free Survival (PFS) as assessed by BICR, per RECIST 1.1. Up to 5 years after first patient randomized.
Secondary Outcomes
No secondary outcomes reported
Investigators
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
Study Sites (51)
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