A Study to Investigate the Effects of Durvalumab with Oleclumab Following Chemoradiation in Participants With Locally Advanced Unresectable Non-Small Cell Lung Cancer (LADOGA) - LADOGA

Study identifier:AZ-RU-00003

ClinicalTrials.gov identifier:NCT06606847

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Phase II, Open-label, Multicentre, Single-arm Study of Durvalumab Plus Oleclumab in Patients With Locally Advanced, Unresectable Non-small Cell Lung Cancer Who Have Not Progressed Following Definitive, Platinum-Based Chemoradiation Therapy (LADOGA)

Medical condition

Non-small Cell Lung Cancer

Phase

Phase 2

Healthy volunteers

Study drug

Oleclumab, Durvalumab

Sex

All

Estimated Enrollment

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 24 Sept 2024

Estimated Primary Completion Date: 30 Jun 2026

Estimated Study Completion Date: 30 Jun 2027

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Participant must be ≥ 18 years at the time of screening.
- Histologically-documented NSCLC and have been treated with concurrent or sequential CRT for locally advanced, unresectable (Stage III) disease.
- Documented tumour PD-L1 status by qualified lab (local or central).
- Documented EGFR and ALK wild-type status (local or central).
- Patients must not have progressed following definitive, platinum based, concurrent or sequential chemoradiotherapy.
- Participants must have received at least 2 cycles of platinum-based chemotherapy before or 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 enrolled. Radiation therapy should be administered by intensity modulated RT/volumetric modulated arc therapy (preferred) or 3D-conforming technique.
- WHO performance status of 0 or 1.
- 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 with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based CRT.
- 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 study treatment assignment. 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 study treatment assignment.
- 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.

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Arms	Assigned Interventions
Experimental: Arm 1 durvalumab plus oleclumab as an IV infusions	-

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]