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Non-Small Cell Lung CancerPhase 2LADOGANCT06606847

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

A Phase 2 study testing Oleclumab and Durvalumab in people with Non-Small Cell Lung Cancer, run by AstraZeneca at 11 sites in Russia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Oleclumab and Durvalumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
11 sitesRussia
Study dates
24 Sep 2024to 30 Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Russia11 sites

  • Research Site

    Kazan', 420029

  • Research Site

    Moscow, 111123

  • Research Site

    Moscow, 115478

  • Research Site

    Moscow, 143423

  • Research Site

    Nizhny Novgorod, 603126

  • Research Site

    Novosibirsk, 630108

  • Research Site

    Obninsk, 249031

  • Research Site

    Saint Petersburg, 197022

  • Research Site

    Saint Petersburg, 197758

  • Research Site

    Ufa, 450054

  • Research Site

    Yekaterinburg, 620905

Other trials in Russia

About this study

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)

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).

Read the 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.

Being tested
Oleclumab, Durvalumab
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
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases, Carcinoma, Bronchogenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OleclumabDrug

    Oleclumab IV (intravenous infusion)

  • DurvalumabDrug

    Durvalumab IV (intravenous infusion)

Study groups in NCT06606847
Study groupRoleWhat they receive
Arm 1Experimentaldurvalumab plus oleclumab as an IV infusions
Receives: Drug: Oleclumab; Drug: Durvalumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From date of first dose until 12 months

Secondary outcomes (7)

  1. Progression free survival (PFS) at 6, 18, and 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.

    Measured: From date of first dose until 24 months

  2. Progression Free Surival (PFS)

    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.

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

  3. Overall survival (OS) at 12 and 24 months

    OS12 and OS24 are defined as the Kaplan-Meier estimate of OS at 12 months and 24 months respectively

    Measured: From date of first dose until 12 and months, respectively

  4. Overall Survival (OS)

    OS is defined as time from the start of treatment until the date of death due to any cause

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

  5. Objective response rate (ORR)

    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

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

  6. Duration of response (DoR)

    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

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

  7. Time to Response (TTR)

    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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2024
  2. Study start24 Sep 2024
  3. Primary completion4 May 2026
  4. Study completion30 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All participants will receive durvalumab and oleclumab as an IV infusions
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06606847
Sponsor's protocol ID
AZ-RU-00003
Acronym
LADOGA
Status last verified
May 2026
First submitted
18 Sep 2024
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oleclumab and Durvalumab in people with Non-Small Cell Lung Cancer, run by AstraZeneca at 11 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) at 12 months (time frame: From date of first dose until 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06606847.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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