Real-World Immuno-Radiotherapy for Advanced NSCLC

NCT06747026 | Completed

• 2 other identifiers: Immuno-radiotherapy in NSCLCUW 23-623
• Study Type: observational
• Target: 338
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer Non-Small Cell Cancer (NSCLC)

Keywords

advanced NSCLC; ICIs; radiotherapy; iRT

Outcome Measures

Primary Outcomes (1)

• OS (overall survival)

  OS is defined as the time from the initiation of iRT until death from any cause.

  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.

Study Arms (3)

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).

Drug: initial Sequential iRT; Drug: initial Concurrent iRT

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).

Drug: initial Sequential iRT; Drug: initial Concurrent iRT

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).

Drug: RT with maintenance of ICI; Drug: RT after discontinuation of ICI

Interventions

initial Sequential iRT 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 iRT for de novo metastatic NSCLC; initial iRT for locally advanced NSCLC

initial Concurrent iRT 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; initial iRT for locally advanced NSCLC

RT with maintenance of ICI DRUG

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

Salvage iRT in post-treatment progressive NSCLC

RT after discontinuation of ICI DRUG

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

Salvage iRT in post-treatment progressive NSCLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Advanced NSCLC patients undergo immunotherapy combined with radiotherapy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fengming Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, HongKong, 999077, Hong Kong

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: January 1, 2015
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)