NCT05484583

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

Prospective Phase ii Clinical Study of the Efficacy and Safety of Durvalumab Combined With Consolidation Radiotherapy After First-line Treatment With Platinum-containing Chemotherapy in Extensive Stage Small Cell Lung Cancer With Oligometastases (1-5 Lesions)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

To explore the efficacy and safety of consolidation radiotherapy after Durvalumab immunotherapy combined with chemotherapy in patients with oligometastatic small cell lung cancer (1-5 lesions), so as to provide scientific basis for making the best comprehensive treatment plan in the future.All subjects will receive the following treatments: 1. Induction period (3 weeks as a cycle, 4 cycles of administration): Durvalumab + carboplatin/cisplatin + etoposide, intravenous drip 2. Consolidation radiotherapy period: radiotherapy for primary chest lesions + oligometastatic lesions. 3. Maintenance phase (administered every 4 weeks): Durvalumab intravenous infusion.

Conditions

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

Interventions

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

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-08-01
• Completion: 2027-08-01
• First posted: 2022-08-02
• Last updated: 2022-08-05