Real-World Immuno-Radiotherapy for Advanced NSCLC

NCT ID: NCT06747026

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 338 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2024-12-01

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.

Conditions

Lung Cancer Non-Small Cell Cancer (NSCLC)

Keywords

advanced NSCLC; ICIs; radiotherapy; iRT

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

initial iRT for locally advanced NSCLC

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 Sequential iRT

Intervention Type: DRUG

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.

initial Concurrent iRT

Intervention Type: DRUG

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.

initial iRT for de novo metastatic NSCLC

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 Sequential iRT

Intervention Type: DRUG

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.

initial Concurrent iRT

Intervention Type: DRUG

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.

Salvage iRT in post-treatment progressive NSCLC

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).

RT with maintenance of ICI

Intervention Type: DRUG

For post-treatment progressive NSCLC, salvage radiotherapy performed during immunotherapy.

RT after discontinuation of ICI

Intervention Type: DRUG

For post-treatment progressive NSCLC, salvage radiotherapy performed during within 90 days after the cessation of immunotherapy.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

RT with maintenance of ICI

For post-treatment progressive NSCLC, salvage radiotherapy performed during immunotherapy.

Intervention Type: DRUG

RT after discontinuation of ICI

For post-treatment progressive NSCLC, salvage radiotherapy performed during within 90 days after the cessation of immunotherapy.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fengming Kong

OTHER

Sponsor Role: lead

Responsible Party

Fengming Kong

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Queen Mary Hospital

Hong Kong, HongKong, Hong Kong

Countries

Hong Kong

Other Identifiers

UW 23-623

Identifier Type: REGISTRY

Identifier Source: secondary_id

Immuno-radiotherapy in NSCLC

Identifier Type: -

Identifier Source: org_study_id