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

NCT05068232 | Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB21-0776
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Small-cell Lung Cancer; Extensive-stage Small-cell Lung Cancer; Lung Cancer

Keywords

small cell lung cancer; extensive small lung cancer; lung cancer

Outcome Measures

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.

  48 months

Secondary Outcomes (5)

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

  3 months

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

  48 months

• Time to Second-Line Therapy

  48 months

• Time to New, Distant Lesions

  48 months

• Progression Free Survival at 12 Months

  12 months

Study Arms (1)

Participants With Extensive Small Cell Lung Cancer (All Participants)

EXPERIMENTAL

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; Drug: Durvalumab; Drug: Etoposide; Drug: Carboplatin

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.

Also known as: Stereotactic Body Radiation Therapy (SBRT)

Participants With Extensive Small Cell Lung Cancer (All Participants)

Durvalumab DRUG

Durvalumab is an immunotherapy drug -- a drug used to help boost your immune response to fight cancer.

Also known as: IMFINZI

Participants With Extensive Small Cell Lung Cancer (All Participants)

Etoposide DRUG

Etoposide is a chemotherapy drug approved for different kinds of cancer, including small cell lung cancer.

Also known as: VP-16

Participants With Extensive Small Cell Lung Cancer (All Participants)

Carboplatin DRUG

Carboplatin is a chemotherapy drug approved for different kinds of cancer, including small cell lung cancer.

Participants With Extensive Small Cell Lung Cancer (All Participants)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Brain metastases must be asymptomatic or treated and stable off steroids and anti-convulsant for at least 2 weeks prior to study treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Life expectancy of at least 12 weeks
• Body weight \>30 kg
• Adequate normal organ and marrow function as defined by lab values the study doctor will review.
• 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.
• 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.
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• Any concurrent chemotherapy, investigational product (IP), biologic, or hormonal therapy for cancer treatment, outside of those specified as part of this clinical trial. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
• Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug
• Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
• History of allogenic organ transplantation.
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
• Patients with vitiligo or alopecia
• Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
• Any chronic skin condition that does not require systemic therapy
• Patients without active disease in the last 5 years may be included but only after consultation with the study physician
• Patients with celiac disease controlled by diet alone
• Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (2)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

RECRUITING

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Lung Neoplasms

Interventions

Radiosurgery; durvalumab; Etoposide; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Coordination Complexes

Study Officials

• Christine Bestvina, MD

  University of Chicago - Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer Clinical Trials Office

CONTACT

1-855-702-8222; cancerclinicaltrials@bsd.uchicago.edu

Aditya Juloori, MD

CONTACT

PhaseIICRA@medicine.bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 5, 2021
• Study Start: August 19, 2022
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (2)