ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2022-02-07
Study Completion:2030-07-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05221840

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant must be ≥ 18 years at the time of screening.
  2. * Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
  3. * Provision of a tumour tissue sample obtained prior to CRT
  4. * Documented tumour PD-L1 status by central lab
  5. * Documented EGFR and ALK wild-type status (local or central).
  6. * Patients must not have progressed following definitive, platinum based, concurrent chemoradiotherapy
  7. * Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy
  8. * 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.
  9. * WHO performance status of 0 or 1 at randomization
  10. * Adequate organ and marrow function
  1. * 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.
  2. * Mixed small cell and non-small cell lung cancer histology.
  3. * Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
  4. * Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
  5. * Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy (excluding alopecia).
  6. * Participants with ≥grade 2 pneumonitis from prior chemoradiation therapy.
  7. * 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.
  8. * Active or prior documented autoimmune or inflammatory disorders (with exceptions)
  9. * Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

Research Site
San Diego, California, 92123
United States
Research Site
New Haven, Connecticut, 06510
United States
Research Site
Stuart, Florida, 34994
United States
Research Site
Urbana, Illinois, 61801
United States
Research Site
New Albany, Indiana, 47150
United States
Research Site
Lexington, Kentucky, 40503
United States
Research Site
Louisville, Kentucky, 40241
United States
Research Site
Annapolis, Maryland, 21401
United States
Research Site
Baltimore, Maryland, 21201
United States
Research Site
Baltimore, Maryland, 21229
United States
Research Site
Bethesda, Maryland, 20817
United States
Research Site
Grand Rapids, Michigan, 49503
United States
Research Site
Duluth, Minnesota, 55805
United States
Research Site
Billings, Montana, 59101
United States
Research Site
Ridgewood, New Jersey, 07450
United States
Research Site
Ithaca, New York, 14850
United States
Research Site
Greensboro, North Carolina, 27403
United States
Research Site
Cleveland, Ohio, 44124
United States
Research Site
Cleveland, Ohio, 44195
United States
Research Site
Maumee, Ohio, 43537
United States
Research Site
Portland, Oregon, 97239
United States
Research Site
Philadelphia, Pennsylvania, 19104
United States
Research Site
York, Pennsylvania, 17403
United States
Research Site
Sioux Falls, South Dakota, 57105
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Charlottesville, Virginia, 22908
United States
Research Site
Fairfax, Virginia, 22031
United States
Research Site
Fredericksburg, Virginia, 22408
United States
Research Site
Richmond, Virginia, 23235
United States
Research Site
Richland, Washington, 99352
United States
Research Site
Spokane, Washington, 99204
United States
Research Site
Tacoma, Washington, 98405
United States
Research Site
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: AstraZeneca

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

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 Registration Dates

Study Start Date2022-02-07
Study Completion Date2030-07-02

Study Record Updates

Study Start Date2022-02-07
Study Completion Date2030-07-02

Terms related to this study

Keywords Provided by Researchers

  • Non-Small Cell Lung Cancer
  • Locally Advanced NSCLC

Additional Relevant MeSH Terms

  • Non-Small Cell Lung Cancer