Extensive-stage Small-cell Lung Cancer, Lung Cancer, Small-cell Lung Cancer
Conditions
Keywords
small cell lung cancer, extensive small lung cancer, lung cancer
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.
Interventions
RADIATIONAblative 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.
DRUGDurvalumab
Durvalumab is an immunotherapy drug -- a drug used to help boost your immune response to fight cancer.
DRUGEtoposide
Etoposide is a chemotherapy drug approved for different kinds of cancer, including small cell lung cancer.
DRUGCarboplatin
Carboplatin is a chemotherapy drug approved for different kinds of cancer, including small cell lung cancer.
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For inclusion in the study patients must fulfill all of the following criteria: 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. Age \> 18 years at time of study entry. 3. Have a histologic/clinically confirmed diagnosis of small cell lung cancer with known metastatic disease. 4. Patient is suitable to receive a platinum-based chemotherapy regimen as first line treatment for extensive stage small cell lung cancer. 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. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 7. Life expectancy of at least 12 weeks 8. Body weight \>30 kg 9. Adequate normal organ and marrow function as defined by lab values the study doctor will review. 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. 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. 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. 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. 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.
Exclusion criteria
Patients should not enter the study if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival of Participant Until Disease Progression or Death | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Participants with Grade 3/4 Adverse Events After 3 Months According to the Common Terminology Criteria for Adverse Events | 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 | 48 months | The overall survival rate of participants after treatment with chemotherapy, durvalumab, and hypofractionated ablative radiotherapy. |
| Time to Second-Line Therapy | 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 | 48 months | Time to development of new distant lesions as assessed clinical records. |
| Progression Free Survival at 12 Months | 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). |
Countries
United States
Contacts
CONTACTCancer Clinical Trials Office
CONTACTAditya Juloori, MD
PRINCIPAL_INVESTIGATORChristine Bestvina, MD
University of Chicago - Comprehensive Cancer Center
Outcome results
None listed