NCT06747026

Real-World Immuno-Radiotherapy for Advanced NSCLC

Real-world Survival Outcomes and the Evaluation of Optimal Strategies for Immuno-Radiotherapy in Advanced Non-Small-Cell Lung Cancer: a Territory-wide Study (OCEANUS Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 338 (actual)
• Sponsor: Fengming Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The optimal combination strategy for radiotherapy combined with immunotherapy (iRT) in advanced non-small-cell lung cancer (NSCLC) remains unclear, and there is a lack of real-world data to validate its efficacy. The objective of this study is to confirm the survival benefits of iRT in advanced NSCLC and to identify the optimal combination strategy for its use.

Detailed description

The PACIFIC study has established radiotherapy combined with immune checkpoint inhibitors (iRT) as the primary treatment modality for unresectable, locally advanced non-small-cell lung cancer (NSCLC). Simultaneously, the KEYNOTE-001 study provided evidence supporting the efficacy of iRT in patients with metastatic and progressive NSCLC. However, most available evidence comes from interventional clinical trials, where participants are rigorously selected and required to adhere strictly to protocol-defined interventions. This creates a significant gap in real-world data, which is essential to further validate the survival benefits of iRT in advanced NSCLC. Furthermore, clinical trials evaluating concurrent iRT in NSCLC have largely yielded negative or inconclusive results, highlighting the need for clarity on the optimal combination strategy for iRT. To address these gaps, researchers will conduct a territory-wide real-world cohort study. The objective of this study is to validate the survival benefits of iRT in patients with advanced NSCLC and to identify the optimal sequential strategy for iRT.

Conditions

• Lung Cancer Non-Small Cell Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	initial Sequential iRT	For unresectable locally advanced NSCLC, definitive thoracic radiotherapy must have been administered as the initial treatment, with immunotherapy initiated within 90 days after RT. For de novo metastatic NSCLC, radiotherapy targeting the primary lung tumor or metastatic lesions must have been administered as the initial treatment, with immunotherapy initiated within 90 days.
DRUG	initial Concurrent iRT	For unresectable locally advanced NSCLC, definitive thoracic radiotherapy must have been administered as the initial treatment, with immunotherapy concurrently with RT. For de novo metastatic NSCLC, radiotherapy targeting the primary lung tumor or metastatic lesions must have been administered as the initial treatment, with immunotherapy concurrently with RT.
DRUG	RT with maintenance of ICI	For post-treatment progressive NSCLC, salvage radiotherapy performed during immunotherapy.
DRUG	RT after discontinuation of ICI	For post-treatment progressive NSCLC, salvage radiotherapy performed during within 90 days after the cessation of immunotherapy.

Timeline

• Start date: 2015-01-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2024-12-24
• Last updated: 2024-12-24

Locations

1 site across 1 country: Hong Kong