Durvalumab Combined With Consolidation Radiotherapy After First-line Treatment in Extensive Stage Small Cell Lung Cancer With Oligometastases

Sponsor
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Study ID
NCT05484583
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Extensive-stage Small-cell Lung Cancer
  • Lung Cancer
  • Radiotherapy

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab + carboplatin/cisplatin + etoposide — DRUG
    Induction period (3 weeks as a cycle, 4 cycles of administration): Durvalumab + carboplatin/cisplatin + etoposide, intravenous drip
  • Consolidation radiotherapy — RADIATION
    Consolidation radiotherapy period: radiotherapy for primary chest lesions + oligometastatic lesions.
  • Durvalumab — DRUG
    Maintenance phase (administered every 4 weeks): Durvalumab intravenous infusion

Study Details

In patients with oligometastatic (1-5 lesions) extensive-stage small cell lung cancer, to explore the efficacy and safety of Durvalumab immunotherapy combined with chemotherapy followed by consolidation radiotherapy, to provide scientific basis for the formulation of the best comprehensive treatment plan in the future.

Key Dates

Start date
Aug 1, 2022
Status verified
Jul 2022
Primary completion
Aug 1, 2024
Completion
Aug 1, 2027

Study Design

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

Arms

  • Experimental: Radiotherapy combined with Durvalumab, etoposide, and cisplatin/carboplatin
    Radiotherapy combined with Durvalumab, etoposide, and cisplatin/carboplatin

Primary Outcome Measure

overall survival time [ Time Frame: up to 2 years ]

Central Contacts

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