Real-World Immuno-Radiotherapy for Advanced NSCLC

Completed

• Conditions: Lung Cancer Non-Small Cell Cancer (NSCLC)
• Interventions: Drug: initial Sequential iRT; Drug: RT with maintenance of ICI; Drug: initial Concurrent iRT; Drug: RT after discontinuation of ICI

• Registration Number: NCT06747026
• Lead Sponsor: Fengming Kong

Brief 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.

Study Timeline

• Study Start: 2015-01-01
• Status Verified: 2024-12
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-18
• Last Update Submitted: 2024-12-18
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 338

Inclusion Criteria

• NSCLC patients who received immunotherapy between 2015 and 2021
• For unresectable locally advanced NSCLC: definitive thoracic radiotherapy must have been administered as the initial treatment, with immunotherapy initiated within 90 days after RT or 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 initiated within 90 days after RT or concurrently with RT
• For post-treatment progressive NSCLC: salvage radiotherapy must have been performed during immunotherapy or within 90 days after the cessation of immunotherapy
• Age >= 18 years old

Exclusion Criteria

• Patients with multiple primary cancers or a pathological diagnosis of small cell lung cancer
• Patients who did not receive radiotherapy or who did not undergo radiotherapy within 90 days before or after immunotherapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
initial iRT for locally advanced NSCLC	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 (Sequential iRT) or concurrently with RT (Concurrent iRT).
initial iRT for locally advanced NSCLC	initial Concurrent 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 (Sequential iRT) or concurrently with RT (Concurrent iRT).
initial iRT for de novo metastatic NSCLC	initial Sequential iRT	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 after RT (Sequential iRT) or concurrently with RT (Concurrent iRT).
initial iRT for de novo metastatic NSCLC	initial Concurrent iRT	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 after RT (Sequential iRT) or concurrently with RT (Concurrent iRT).
Salvage iRT in post-treatment progressive NSCLC	RT with maintenance of ICI	For post-treatment progressive NSCLC: salvage radiotherapy must have been performed during immunotherapy or within 90 days after the cessation of immunotherapy (RT after discontinuation of ICI) , or concurrently with RT (RT with maintenance of ICI).
Salvage iRT in post-treatment progressive NSCLC	RT after discontinuation of ICI	For post-treatment progressive NSCLC: salvage radiotherapy must have been performed during immunotherapy or within 90 days after the cessation of immunotherapy (RT after discontinuation of ICI) , or concurrently with RT (RT with maintenance of ICI).

Primary Outcome Measures

Name	Time	Method
OS (overall survival)	From the initiation date of iRT to the date of death from any cause, with a follow-up period of up to approximately 5 years.	OS is defined as the time from the initiation of iRT until death from any cause.

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 HongKong, Hong Kong