NCT05161533

Hypofractionated Radiation Therapy After Durvalumab and Chemotherapy for the Treatment of Stage IV Extensive Stage Small Cell Lung Cancer, CASPIAN-RT Trial

CASPIAN-RT Trial: Hypofractionated Consolidative Radiation Therapy After Durvalumab (MEDI4736) Plus Platinum-Based Chemotherapy in Extensive Stage Small Cell Lung Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well hypofractionated radiation therapy after durvalumab and chemotherapy works to shrink tumors in patients with stage IV extensive stage small cell lung cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects than a conventionally fractionated radiation course. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as carboplatin, cisplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding radiation after chemo and immunotherapy may help improve cancer control.

Detailed description

OUTLINE: INDUCTION: Patients receive standard of care chemotherapy consisting of carboplatin or cisplatin and etoposide. Patients also receive durvalumab intravenously (IV) on day 1 of each cycle. Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive durvalumab IV on day 1 of each cycle. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Beginning cycle 5 or 6 of durvalumab, patients undergo hypofractionated radiation therapy. After completion of study treatment, patients are followed up every 3 months.

Conditions

• Extensive Stage Lung Small Cell Carcinoma
• Stage IV Lung Cancer AJCC v8
• Stage IVA Lung Cancer AJCC v8
• Stage IVB Lung Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Carboplatin	Given IV
DRUG	Cisplatin	Given IV
BIOLOGICAL	Durvalumab	Given IV
DRUG	Etoposide	Given IV
RADIATION	Hypofractionated Radiation Therapy	Undergo hypofractionated radiation therapy
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2023-10-19
• Primary completion: 2024-10-01
• Completion: 2024-12-31
• First posted: 2021-12-17
• Last updated: 2023-10-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study