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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT05068232
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ablative Radiation — RADIATION
    Ablative radiation therapy is a highly focused radiation treatment that gives an intense dose of radiation concentrated on a tumor or very specific area of the body, while limiting the radiation that affects surrounding organs.
  • Durvalumab — DRUG
    Durvalumab is an immunotherapy drug -- a drug used to help boost your immune response to fight cancer.
  • Etoposide — DRUG
    Etoposide is a chemotherapy drug approved for different kinds of cancer, including small cell lung cancer.
  • Carboplatin — DRUG
    Carboplatin is a chemotherapy drug approved for different kinds of cancer, including small cell lung cancer.

Study Details

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.

Key Dates

Start date
Aug 19, 2022
Status verified
Mar 2026
Primary completion
Oct 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
49 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants With Extensive Small Cell Lung Cancer (All Participants)
    This arm will involve all participants in the study who have extensive small cell lung cancer that has not responded to previous treatments. All participants will receive the same treatment of study drugs and radiation treatment in "cycles" (a specific window of time). You will receive up to four 21-day cycles of chemotherapy using carboplatin, etoposide and durvalumab (immunotherapy) as part of a standard care treatment plan recommended by your doctor. These drugs will be combined with ablative radiation treatment during the second cycle of chemotherapy. After completing these four cycles of chemotherapy (with radiation treatment added in cycle 2), you will continue to receive a fixed dose of durvalumab until your cancer progresses, you experience serious side effects, you decide to no longer be part of the study or the study doctor request to take you off the study for medical reasons.

Primary Outcome Measure

Progression-Free Survival of Participant Until Disease Progression or Death [ Time Frame: 48 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Chicago MedicineChicagoIllinois60637
Clinical Trials Intake
[email protected]
855-702-8222
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792-

Find similar trials in Chicago, IL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Chicago Medicine· Chicago, ILUniversity of Wisconsin Carbone Cancer Center· Madison, WI

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