RECRUITING

A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC

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Conditions

Non-Small Cell Lung Cancerlocally advancedNSCLC

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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, placebo-controlled, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) and domvanalimab (AB154) compared with durvalumab plus placebo in adults with locally advanced (Stage III), unresectable NSCLC whose disease has not progressed following definitive platinum-based cCRT.

Official Title

A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre, International Study of Durvalumab Plus Domvanalimab(AB154) in Participants With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer Whose Disease Has Not Progressed Following Definitive Platinum-based Concurrent Chemoradiation Therapy

Quick Facts

Study Start:2022-02-18
Study Completion:2030-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05211895

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. 1. Participant must be ≥ 18 years at the time of screening.
  2. 2. Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
  3. 3. Provision of a tumour tissue sample obtained prior to CRT
  4. 4. Documented tumour PD-L1 status ≥ 1% by central lab
  5. 5. Documented EGFR and ALK wild-type status (local or central).
  6. 6. Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy
  7. 7. Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy
  8. 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. 9. WHO performance status of 0 or 1 at randomization
  10. 10. Adequate organ and marrow function
  1. 1. History of another primary malignancy, except for:
  2. * Malignancies treated with curative intent and adequate follow-up with no known active disease and have not required active treatment within the past 3 years before the first dose of study intervention and of low potential risk of recurrence.
  3. * Adequately resected non melanoma skin cancer or lentigo maligna without evidence of disease .
  4. * Adequately treated carcinoma in situ, including Ta tumors without evidence of disease.
  5. 2. Mixed small cell and non-small cell lung cancer histology.
  6. 3. Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
  7. 4. Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
  8. 5. Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy (excluding alopecia).
  9. 6. Participants with ≥ grade 2 pneumonitis from prior chemoradiation therapy.
  10. 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
  11. 8. Active or prior documented autoimmune or inflammatory disorders (with exceptions)
  12. 9. Active EBV infection, or known or suspected chronic active EBV infection at screening
  13. 10. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com
AstraZeneca Lung Cancer Study Locator Service
CONTACT
1-884-432-3892
az-lcsl@careboxhealth.com

Principal Investigator

Hidehito Horinouchi, MD, PhD
PRINCIPAL_INVESTIGATOR
National Cancer Center Hospital
Alexander Spira, MD, PhD
PRINCIPAL_INVESTIGATOR
Virginia Cancer Specialists Research Institute
Jinming Yu, MD, PhD
PRINCIPAL_INVESTIGATOR
Shandong Cancer Hospital and Institute

Study Locations (Sites)

Research Site
Chandler, Arizona, 85224
United States
Research Site
Phoenix, Arizona, 85054
United States
Research Site
Fountain Valley, California, 92708
United States
Research Site
Santa Rosa, California, 95403
United States
Research Site
Washington, District of Columbia, 20016
United States
Research Site
Jacksonville, Florida, 32224
United States
Research Site
Orlando, Florida, 32804
United States
Research Site
Saint Augustine, Florida, 32086
United States
Research Site
Macon, Georgia, 31217
United States
Research Site
Elmhurst, Illinois, 60126
United States
Research Site
Maywood, Illinois, 60153
United States
Research Site
Naperville, Illinois, 60540
United States
Research Site
Louisville, Kentucky, 40202
United States
Research Site
Baltimore, Maryland, 21224
United States
Research Site
Silver Spring, Maryland, 20910
United States
Research Site
Detroit, Michigan, 48202
United States
Research Site
Minneapolis, Minnesota, 55407
United States
Research Site
Rochester, Minnesota, 55905
United States
Research Site
East Brunswick, New Jersey, 08816
United States
Research Site
Florham Park, New Jersey, 07932
United States
Research Site
Buffalo, New York, 14221
United States
Research Site
Johnson City, New York, 13790
United States
Research Site
Asheville, North Carolina, 28805
United States
Research Site
Asheville, North Carolina, 28806
United States
Research Site
Charlotte, North Carolina, 28204
United States
Research Site
Winston-Salem, North Carolina, 27157
United States
Research Site
Columbus, Ohio, 43219
United States
Research Site
Oklahoma City, Oklahoma, 73102
United States
Research Site
Pittsburgh, Pennsylvania, 15212
United States
Research Site
Charleston, South Carolina, 29401
United States
Research Site
Nashville, Tennessee, 37232
United States
Research Site
Fort Sam Houston, Texas, 78234
United States
Research Site
Arlington, Virginia, 22205
United States
Research Site
Fort Belvoir, Virginia, 22060
United States
Research Site
Spokane Valley, Washington, 99216
United States

Collaborators and Investigators

Sponsor: AstraZeneca

  • Hidehito Horinouchi, MD, PhD, PRINCIPAL_INVESTIGATOR, National Cancer Center Hospital
  • Alexander Spira, MD, PhD, PRINCIPAL_INVESTIGATOR, Virginia Cancer Specialists Research Institute
  • Jinming Yu, MD, PhD, PRINCIPAL_INVESTIGATOR, Shandong Cancer Hospital and Institute

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 Date2022-02-18
Study Completion Date2030-08-30

Study Record Updates

Study Start Date2022-02-18
Study Completion Date2030-08-30

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