NCT05403723

Adaptive SBRT Plus Chemoimmunotherapy for ES-SCLC

A Phase 1b Trial of Adaptive Stereotactic Body Radiotherapy in Combination With Durvalumab (MEDI4736), Platinum, and Etoposide in Extensive Stage Small Cell Lung Cancer

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is trial studying the safety of adaptive stereotactic body radiotherapy (SBRT) combined with durvalumab immunotherapy, platinum chemotherapy, and etoposide chemotherapy in platinum refractory extensive stage small cell lung cancer (SCLC).

Detailed description

This is a phase Ib, open-label, single-arm study in newly diagnosed patients with extensive stage SCLC, to test the safety of the adaptive addition of SBRT to combination therapy with durvalumab, platinum, and etoposide. Approximately 50 patients with ES-SCLC will be enrolled in this study in order to identify 20 patients with platinum refractory disease who do not show evidence of early response to chemoimmunotherapy. Eligible patients will complete 2 cycles of study treatment with durvalumab, platinum (cisplatin or carboplatin per investigator choice), and etoposide. Patients will then undergo standard of care restaging imaging. Those patients who have a partial or complete response will continue with combination systemic therapy, without additional intervention. In patients with less than a partial response (stable disease or progressive disease), SBRT will be given prior to cycle 3 of systemic therapy. The radiotherapy will be given in 5 fractions of 6 Gy to the primary tumor site. See study schema. Patients who undergo SBRT will resume systemic therapy within 2 weeks of completing SBRT and the interval between cycle 2 and cycle 3 should not exceed 6 weeks. Subsequent restaging imaging will continue as per standard of care. All patients will continue maintenance therapy with durvalumab until confirmed progressive disease.

Conditions

• Extensive-stage Small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab 50 MG/1 ML Intravenous Solution	Durvalumab (1500 mg durvalumab via IV infusion) in combination with platinum doublet chemotherapy will be administered to patients once every 3 weeks for up to 4 cycles plus SBRT (platinum resistant group) or without SBRT (platinum sensitive group). Each 3-week of chemoimmunotherapy interval is considered a cycle. Patients with platinum sensitive disease will receive the combination of durvalumab and chemotherapy (total of four cycles) while those with platinum resistant SCLC will receive SBRT and continue to receive up to two additional cycles of treatment with durvalumab along with platinum/etoposide (not to exceed a total of four6 cycles of chemoimmunotherapy including 2 cycles obtained prior to SBRT). Following completion of 4-6 cycles of combination therapy, patients in both groups will continue with maintenance durvalumab (1500 mg) in q4w cycles until disease progression.
DRUG	Etoposide Injection	A platinum/etoposide doublet will be administered according to institutional standards. Platinum-etoposide will consist of etoposide 80-100 mg/m2 on days 1-3 of each cycle along with a choice of either carboplatin area under the curve 5-6 mg/mL per min or cisplatin 75-80 mg/m2 (administered on day 1 of each cycle).
DRUG	Cisplatin	A platinum/etoposide doublet will be administered according to institutional standards. Platinum-etoposide will consist of etoposide 80-100 mg/m2 on days 1-3 of each cycle along with a choice of either carboplatin area under the curve 5-6 mg/mL per min or cisplatin 75-80 mg/m2 (administered on day 1 of each cycle).
DRUG	Carboplatin	A platinum/etoposide doublet will be administered according to institutional standards. Platinum-etoposide will consist of etoposide 80-100 mg/m2 on days 1-3 of each cycle along with a choice of either carboplatin area under the curve 5-6 mg/mL per min or cisplatin 75-80 mg/m2 (administered on day 1 of each cycle).
DEVICE	Stereotactic Body Radiotherapy	Patients will receive palliative radiation to the primary tumor site up to 30 Gy for 1 week given as 5 daily fractions of 6 Gy each or 27 Gy as 3 fractions of 9 Gy administered every other day.

Timeline

• Start date: 2026-06-30
• Primary completion: 2027-02-01
• Completion: 2027-08-01
• First posted: 2022-06-03
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study