A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer

Description

This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.

Conditions

Non-Small Cell Lung Cancer

Study Overview

Study Details

Study overview

This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.

A Phase III, Double-blind, Placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy

A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer

Condition
Non-Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

San Diego

Research Site, San Diego, California, United States, 92123

New Haven

Research Site, New Haven, Connecticut, United States, 06510

Stuart

Research Site, Stuart, Florida, United States, 34994

Urbana

Research Site, Urbana, Illinois, United States, 61801

New Albany

Research Site, New Albany, Indiana, United States, 47150

Waterloo

Research Site, Waterloo, Iowa, United States, 50703

Lexington

Research Site, Lexington, Kentucky, United States, 40503

Louisville

Research Site, Louisville, Kentucky, United States, 40241

Scarborough

Research Site, Scarborough, Maine, United States, 04074

Annapolis

Research Site, Annapolis, Maryland, United States, 21401

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participant must be ≥ 18 years at the time of screening.
  • * Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
  • * Provision of a tumour tissue sample obtained prior to CRT
  • * Documented tumour PD-L1 status by central lab
  • * Documented EGFR and ALK wild-type status (local or central).
  • * Patients must not have progressed following definitive, platinum based, concurrent chemoradiotherapy
  • * Participants must have received at least 2 cycles of platinum-based chemotherapy 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 randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique.
  • * WHO performance status of 0 or 1 at randomization
  • * Adequate organ and marrow function
  • * 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 who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
  • * Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
  • * 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 randomisation. 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 randomization.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Fabrice Barlesi, MD, PRINCIPAL_INVESTIGATOR, Gustave Roussy, Cancer Campus, Grand Paris

Study Record Dates

2030-05-31