Adaptive SBRT Plus Chemoimmunotherapy for ES-SCLC

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT05403723
Phase
PHASE1
Status
Suspended

Conditions

  • Extensive-stage Small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab 50 MG/1 ML Intravenous Solution — DRUG
    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.
  • Etoposide Injection — DRUG
    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).
  • Cisplatin — DRUG
    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).
  • Carboplatin — DRUG
    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).
  • Stereotactic Body Radiotherapy — DEVICE
    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.

Study Details

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).

Key Dates

Start date
Jun 30, 2026
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Treatment Arm
    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.

Primary Outcome Measure

Incidence of treatment-related adverse events (AEs) [ Time Frame: Up to 2.5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201-

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By research site
University of Maryland Greenebaum Comprehensive Cancer Center· Baltimore, MD

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