Durvalumab and Ablative Radiation in Small Cell Lung Cancer (DARES)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05068232|
Recruitment Status : Not yet recruiting
First Posted : October 5, 2021
Last Update Posted : March 28, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Small-cell Lung Cancer Extensive-stage Small-cell Lung Cancer Lung Cancer||Radiation: Ablative Radiation Drug: Durvalumab Drug: Etoposide Drug: Carboplatin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Durvalumab and Ablative Radiation in Extensive-Stage Small Cell Lung Cancer (DARES)|
|Estimated Study Start Date :||June 2022|
|Estimated Primary Completion Date :||October 1, 2027|
|Estimated Study Completion Date :||October 1, 2027|
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.
Radiation: Ablative 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.
Other Name: Stereotactic Body Radiation Therapy (SBRT)
Durvalumab is an immunotherapy drug -- a drug used to help boost your immune response to fight cancer.
Other Name: IMFINZI
Etoposide is a chemotherapy drug approved for different kinds of cancer, including small cell lung cancer.
Other Name: VP-16
Carboplatin is a chemotherapy drug approved for different kinds of cancer, including small cell lung cancer.
- Progression-Free Survival of Participant Until Disease Progression or Death [ Time Frame: 48 months ]The progression-free survival (PFS) of subjects with extensive-stage small cell lung cancer treated with durvalumab, carboplatin and etoposide with hypofractionated ablative radiation therapy. Progression-free survival will be defined as the time from start of treatment until disease progression per Response Evaluation Criteria in Solid Tumors (RECISTv1.1) or death from any cause.
- Rate of Participants with Grade 3/4 Adverse Events After 3 Months According to the Common Terminology Criteria for Adverse Events [ Time Frame: 3 months ]The rate of participants with serious adverse events by organ system that occur within three months of starting radiation, according to Common Terminology Criteria for Adverse Events (CTCAE) v5.
- Overall Survival Rate of Participants After Treatment with Chemotherapy, Durvalumab and Ablative Radiation [ Time Frame: 48 months ]The overall survival rate of participants after treatment with chemotherapy, durvalumab, and hypofractionated ablative radiotherapy.
- Time to Second-Line Therapy [ Time Frame: 48 months ]Time to second-line therapy (from start of treatment until second-line therapy is needed) as assessed by clinical records.
- Time to New, Distant Lesions [ Time Frame: 48 months ]Time to development of new distant lesions as assessed clinical records.
- Progression Free Survival at 12 Months [ Time Frame: 12 months ]The progression-free survival (PFS) of subjects with extensive-stage small cell lung cancer treated with durvalumab, carboplatin and etoposide with hypofractionated ablative radiation therapy at 12 months. Progression-free survival will be defined as the time from start of treatment to 12 months per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05068232
|Contact: Cancer Clinical Trials Officeemail@example.com|
|Contact: Aditya Juloori, MD||PhaseIICRA@medicine.bsd.uchicago.edu|
|Principal Investigator:||Christine Bestvina, MD||University of Chicago - Comprehensive Cancer Center|