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

NCT06606847 | Active Not Recruiting Phase 2

• 1 other identifier: AZ-RU-00003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this Phase II, open-label, multicentre, single-arm study is to assess efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) in participants with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC), who have not progressed following platinum-based concurrent or sequential chemoradiotherapy (cCRT or sCRT).

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; Locally Advanced NSCLC; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Antineoplastic Agents; Durvalumab

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS) at 12 months

  PFS12 is defined as the Kaplan-Meier estimate of PFS at 12 months per RECIST 1.1 as assessed by the investigator.

  From date of first dose until 12 months

Secondary Outcomes (7)

• Progression free survival (PFS) at 6, 18, and 24 months

  From date of first dose until 24 months

• Progression Free Surival (PFS)

  Up to 24 months after the last patient's first dose

• Overall survival (OS) at 12 and 24 months

  From date of first dose until 12 and months, respectively

• Overall Survival (OS)

  Up to 24 months after the last patient's first dose

• Objective response rate (ORR)

  Up to 24 months after the last patient's first dose

Study Arms (1)

Arm 1

EXPERIMENTAL

durvalumab plus oleclumab as an IV infusions

Drug: Oleclumab; Drug: Durvalumab

Interventions

Oleclumab DRUG

Oleclumab IV (intravenous infusion)

Arm 1

Durvalumab DRUG

Durvalumab IV (intravenous infusion)

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (11)

Research Site

Kazan', 420029, Russia

Location

Research Site

Moscow, 111123, Russia

Location

Research Site

Moscow, 115478, Russia

Location

Research Site

Moscow, 143423, Russia

Location

Research Site

Nizhny Novgorod, 603126, Russia

Location

Research Site

Novosibirsk, 630108, Russia

Location

Research Site

Obninsk, 249031, Russia

Location

Research Site

Saint Petersburg, 197022, Russia

Location

Research Site

Saint Petersburg, 197758, Russia

Location

Research Site

Ufa, 450054, Russia

Location

Research Site

Yekaterinburg, 620905, Russia

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Bronchial Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants will receive durvalumab and oleclumab as an IV infusions

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 23, 2024
• Study Start: September 24, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

RU (11)