RECRUITING

Durvalumab and Ablative Radiation in Small Cell Lung Cancer (DARES)

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Conditions

Small-cell Lung CancerExtensive-stage Small-cell Lung CancerLung Cancersmall cell lung cancerextensive small lung cancer

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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 this study is for individuals who have treatment-naïve extensive-stage small cell lung cancer (small cell lung cancer that wont respond to treatment). Doctors leading this study hope to learn if combining durvalumab, carboplatin and etoposide with hyofractionated ablative radiation therapy (radiation focused on certain parts of the body) will help treat your cancer and improve how long you can live with extensive-stage small cell cancer without it getting worse (progression-free survival). Your participation in this research will last about 48 months. Durvalumab along with chemotherapy has been approved by the Food and Drug Administration (FDA) for the treatment of small cell lung cancer along with chemotherapy. This study is testing the addition of radiation to durvalumab and chemotherapy.

Official Title

A Phase II Trial of Durvalumab and Ablative Radiation in Extensive-Stage Small Cell Lung Cancer (DARES)

Quick Facts

Study Start:2022-08-19
Study Completion:2027-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05068232

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. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol.
  2. 2. Age \> 18 years at time of study entry.
  3. 3. Have a histologic/clinically confirmed diagnosis of small cell lung cancer with known metastatic disease.
  4. 4. Patient is suitable to receive a platinum-based chemotherapy regimen as first line treatment for extensive stage small cell lung cancer.
  5. 5. Brain metastases must be asymptomatic or treated and stable off steroids and anti-convulsant for at least 2 weeks prior to study treatment.
  6. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  7. 7. Life expectancy of at least 12 weeks
  8. 8. Body weight \>30 kg
  9. 9. Adequate normal organ and marrow function as defined by lab values the study doctor will review.
  10. 10. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  11. 11. Have measurable disease based on Response Evaluation Criteria in Solid Tumor (RECIST 1.1) including at least ONE lesion that meets criteria for ablative radiation, including 0.25 cc to 65 cc of viable tumor (i.e. primary disease or metastases) approximately 5cm in maximal dimension. Tumors larger than 65 cc can be partially treated.
  12. 12. Female subject of childbearing potential should have a negative urine or serum pregnancy within 24 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  13. 13. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.
  14. 14. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
  1. 1. Participation in another clinical study with an investigational product during the last 2 weeks.
  2. 2. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
  3. 3. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the

Contacts and Locations

Study Contact

Cancer Clinical Trials Office
CONTACT
1-855-702-8222
cancerclinicaltrials@bsd.uchicago.edu
Aditya Juloori, MD
CONTACT
PhaseIICRA@medicine.bsd.uchicago.edu

Principal Investigator

Christine Bestvina, MD
PRINCIPAL_INVESTIGATOR
University of Chicago - Comprehensive Cancer Center

Study Locations (Sites)

University of Chicago Medicine
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Christine Bestvina, MD, PRINCIPAL_INVESTIGATOR, University of Chicago - Comprehensive Cancer Center

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 Date2022-08-19
Study Completion Date2027-10-01

Study Record Updates

Study Start Date2022-08-19
Study Completion Date2027-10-01

Terms related to this study

Keywords Provided by Researchers

  • small cell lung cancer
  • extensive small lung cancer
  • lung cancer

Additional Relevant MeSH Terms

  • Small-cell Lung Cancer
  • Extensive-stage Small-cell Lung Cancer
  • Lung Cancer