Addition of Thoracic Consolidation Radiotherapy to the Maintenance Immunotherapy for ES-SCLC (STONE-001)

Sponsor
Anhui Shi, MD
Study ID
NCT06719336
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Extensive-stage Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • High-dose Hyperfractionated Simultaneous Integrated Boost Radiotherapy — RADIATION
    Twice-daily thoracic radiotherapy at a dose of 54 Gy in 30 fractions with IMRT and VMAT
  • atezolizumab or durvalumab — DRUG
    atezolizumab 1200 mg Q3W or durvalumab 1500 mg Q4W

Study Details

This study is expected to enroll 182 patients with partial response or stable disease after first-line immunochemotherapy for extensive-stage small cell lung cancer and eligible for thoracic consolidation radiotherapy within 2 years. Patients were randomized 2:1 to immune single-agent maintenance therapy in combination with hyperfractionated high-dose radiotherapy and immune single-agent maintenance therapy after being assessed by the investigator as otherwise eligible for enrollment. Patients in both arms received maintenance therapy with the PD-L1 inhibitor, atezolizumab or dulvedolizumab, until disease progression, unacceptable toxicity, or loss of clinical benefit. Patients in the combined radiotherapy arm required hyperfractionated high-dose (54 Gy) radiotherapy twice daily for residual disease in the chest. Each patient will be followed for approximately 2 years.

Key Dates

Start date
Dec 16, 2024
Status verified
Dec 2024
Primary completion
Dec 16, 2028
Completion
Dec 16, 2028

Study Design

Enrollment
182 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Addition of thoracic consolidation radiotherapy to the maintenance therapy with PD-L1 inhibitor
  • Active Comparator: Maintenance therapy with PD-L1 inhibitor

Primary Outcome Measure

Overall survival (OS) [ Time Frame: From randomization to the date of death due to any cause, assessed up to 4 years ]

Central Contacts

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