Clinical trial NCT06747026: Real-World Immuno-Radiotherapy for Advanced NSCLC
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer Non-Small Cell Cancer (NSCLC)
Keywords: advanced NSCLC
ICIs
radiotherapy
iRT
Lead sponsor: The University of Hong Kong-Shenzhen Hospital
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Advanced NSCLC patients undergo immunotherapy combined with radiotherapy.

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.

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

Primary outcomes:
measure: OS (overall survival)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: HongKong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
References: