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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 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 RecruitingPhase 2

Sponsor: AstraZeneca

Conditions: Non-Small Cell Lung Cancer

Interventions: Oleclumab, Durvalumab

Countries: Russia

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).

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
* 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.
Locations (11)
  • Kazan', Russia
  • Moscow, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Nizhny Novgorod, Russia
  • Novosibirsk, Russia
  • Obninsk, Russia
  • Saint Petersburg, Russia
  • Saint Petersburg, Russia
  • Ufa, Russia
  • Yekaterinburg, Russia