NCT04951115

A Trial With Chemotherapy, Immunotherapy, and Radiotherapy for Patients With Newly Diagnosed Stage IV Small Cell Lung Cancer

Phase II Trial of Platinum-Etoposide Chemotherapy and Durvalumab (MEDI4736) With Sub-Ablative SBRT in Patients With Newly Diagnosed Stage IV Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is for subjects with untreated Stage IV small cell lung cancer. Subjects will be given radiation therapy for five days, followed by standard of care chemo-immunotherapy (etoposide + carboplatin or cisplatin + durvalumab) for 4 cycles. Subjects may continue to receive durvalumab after 4 cycles have been completed until disease progression.

Detailed description

This is a non-randomized, open-label, single-arm pilot phase II study of non-ablative stereotactic body radiotherapy (SBRT) in combination with standard-of-care chemo-immunotherapy in patients with untreated, extensive-stage (Stage IV) small cell lung cancer. Subjects will be treated with etoposide plus platinum (carboplatin or cisplatin) chemotherapy together with the PD-L1 checkpoint inhibitor durvalumab, which is a standard of care in this disease setting. Subjects will also receive a total of 6 Gy of radiotherapy X 5 fractions targeting multiple sites of intrathoracic disease when feasible and starting on the first day of the first cycle of chemo-immunotherapy; no further radiation will be planned after this. The hypothesis of this study is that the addition of sub-ablative doses of radiation to combination chemotherapy and immunotherapy will be safe and feasible and result in improved outcomes for patients with treatment-naive, extensive-stage small cell lung cancer.

Conditions

• Small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	AUC = 5-6 mg/mL per min on Day 1 of each 21-day cycle, for 4 cycles
DRUG	Cisplatin	75-80 mg/m2 on Day 1 of each 21-day cycle, for 4 cycles
DRUG	Etoposide	80-100 mg/m2 on Day 1, Day 2, and Day 3 of each 21-day cycle, for 4 cycles
DRUG	Durvalumab	1500 mg on Day 1 of each 21-day cycle, for 4 cycles. Following this, 1500 mg once every 4 weeks until disease progression
RADIATION	Stereotactic Body Radiotherapy	6 Gy of radiotherapy targeting multiple sites of intrathoracic disease on Days 1-5 of cycle 1.

Timeline

• Start date: 2021-07-12
• Primary completion: 2024-01-17
• Completion: 2024-01-17
• First posted: 2021-07-06
• Last updated: 2024-11-26
• Results posted: 2024-11-26

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study