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)

May 14, 2026 updated by: AstraZeneca

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)

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase II, open-label, multicentre, single-arm study assessing the efficacy and safety of durvalumab in combination with oleclumab in participants with locally advanced (Stage III), unresectable NSCLC with WHO performance status of 0 or 1, who have not progressed on prior platinum-based CRT.

All participants will be assigned to receive durvalumab and oleclumab as an IV infusions for up to 12 months (last dose should be administered at week 48). The last administration at Week 48, or until clinical progression, confirmed RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or an intervention discontinuation criterion is met.

The results of this study will provide clinical data on efficacy and safety of an innovation treatment in the new region - Russian Federation.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russia
      • Kazan', Russia, 420029
        • Research Site
      • Moscow, Russia, 115478
        • Research Site
      • Moscow, Russia, 111123
        • Research Site
      • Moscow, Russia, 143423
        • Research Site
      • Nizhny Novgorod, Russia, 603126
        • Research Site
      • Novosibirsk, Russia, 630108
        • Research Site
      • Obninsk, Russia, 249031
        • Research Site
      • Saint Petersburg, Russia, 197758
        • Research Site
      • Saint Petersburg, Russia, 197022
        • Research Site
      • Ufa, Russia, 450054
        • Research Site
      • Yekaterinburg, Russia, 620905
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
durvalumab plus oleclumab as an IV infusions
Drug: Durvalumab
Durvalumab IV (intravenous infusion)
Drug: Oleclumab
Oleclumab IV (intravenous infusion)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS) at 12 months
Time Frame: From date of first dose until 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS) at 6, 18, and 24 months
Time Frame: From date of first dose until 24 months
PFS6, PFS18 and PFS24 are defined as the Kaplan-Meier estimate of PFS at 6 months, 18 months and 24 months respectively, per RECIST 1.1 as assessed by the investigator.
From date of first dose until 24 months
Progression Free Surival (PFS)
Time Frame: Up to 24 months after the last patient's first dose
PFS is defined as time from the start of treatment until progression per RECIST 1.1 as assessed by the investigator, or death due to any cause.
Up to 24 months after the last patient's first dose
Overall survival (OS) at 12 and 24 months
Time Frame: From date of first dose until 12 and months, respectively
OS12 and OS24 are defined as the Kaplan-Meier estimate of OS at 12 months and 24 months respectively
From date of first dose until 12 and months, respectively
Overall Survival (OS)
Time Frame: Up to 24 months after the last patient's first dose
OS is defined as time from the start of treatment until the date of death due to any cause
Up to 24 months after the last patient's first dose
Objective response rate (ORR)
Time Frame: Up to 24 months after the last patient's first dose
ORR is defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR), as determined by the investigator per RECIST 1.1
Up to 24 months after the last patient's first dose
Duration of response (DoR)
Time Frame: Up to 24 months after the last patient's first dose
DoR is defined as the time from first response until progression per RECIST 1.1 as assessed by the investigator, or death due to any cause
Up to 24 months after the last patient's first dose
Time to Response (TTR)
Time Frame: Up to 24 months after the last patient's first dose
TTR is defined as the time from the start of the treatment to the first documented objective tumor response observed for participants who achieved CR or PR, as determined by the investigator according to RECIST 1.1
Up to 24 months after the last patient's first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2024

Primary Completion (Actual)

May 4, 2026

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Actual)

September 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZ-RU-00003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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