Health TrialsbyHealthPanel

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

ConditionsSmall-cell Lung CancerExtensive-stage Small-cell Lung CancerLung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Age > 18 years at time of study entry.

Have a histologic/clinically confirmed diagnosis of small cell lung cancer with known metastatic disease.

Patient is suitable to receive a platinum-based chemotherapy regimen as first line treatment for extensive stage small cell lung cancer.

Disqualifiers

Participation in another clinical study with an investigational product during the last 2 weeks.

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

Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.

Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

49 Participants
are divided into 1 treatment group
Group A: Participants With Extensive Small Cell Lung Cancer (All Participants)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival of Participant Until Disease Progression or Death

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.

Time frame
48 months

Secondary outcomes

1

Rate of Participants with Grade 3/4 Adverse Events After 3 Months According to the Common Terminology Criteria for Adverse Events

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.

Time frame
3 months
2

Overall Survival Rate of Participants After Treatment with Chemotherapy, Durvalumab and Ablative Radiation

The overall survival rate of participants after treatment with chemotherapy, durvalumab, and hypofractionated ablative radiotherapy.

Time frame
48 months
3

Time to Second-Line Therapy

Time to second-line therapy (from start of treatment until second-line therapy is needed) as assessed by clinical records.

Time frame
48 months
4

Time to New, Distant Lesions

Time to development of new distant lesions as assessed clinical records.

Time frame
48 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

Source ClinicalTrials.gov
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