Lung Cancer Non-Small Cell Cancer (NSCLC)OCEANUSNCT06747026
Real-World Immuno-Radiotherapy for Advanced NSCLC
An observational study of Lung Cancer Non-Small Cell Cancer (NSCLC), run by Fengming Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Non-Small Cell Cancer (NSCLC)
- What is being tested?
- initial Sequential iRT, initial Concurrent iRT and RT with maintenance of ICI
- How many people
- 338 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2015to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced NSCLC patients undergo immunotherapy combined with radiotherapy.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Being tested
- initial Sequential iRT, initial Concurrent iRT, RT with maintenance of ICI, RT after discontinuation of ICI
- Keywords
- advanced NSCLC, ICIs, radiotherapy, iRT
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
initial Sequential iRTDrug
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 iRTDrug
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.
RT with maintenance of ICIDrug
For post-treatment progressive NSCLC, salvage radiotherapy performed during immunotherapy.
RT after discontinuation of ICIDrug
For post-treatment progressive NSCLC, salvage radiotherapy performed during within 90 days after the cessation of immunotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Drug: RT with maintenance of ICI; Drug: RT after discontinuation of ICI |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS (overall survival)
OS is defined as the time from the initiation of iRT until death from any cause.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Jan 2015
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer Non-Small Cell Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fengming Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fengming Kong, The University of Hong Kong-Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747026
- Sponsor's protocol ID
- Immuno-radiotherapy in NSCLC
- Other IDs
- UW 23-623
- Acronym
- OCEANUS
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06747026
- Acronym / sponsor ID
- OCEANUS / Immuno-radiotherapy in NSCLC
- Keywords
- advanced NSCLC, ICIs, radiotherapy, iRT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Fengming KongUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| initial iRT for locally advanced NSCLC | – | Drug: initial Sequential iRT, Drug: initial Concurrent iRTFor 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 | – | Drug: initial Sequential iRT, Drug: initial Concurrent iRTFor 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 | – | Drug: RT with maintenance of ICI, Drug: RT after discontinuation of ICIFor 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced NSCLC patients undergo immunotherapy combined with radiotherapy.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| initial Sequential iRTFor 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 iRT for de novo metastatic NSCLC, initial iRT for locally advanced NSCLC |
| initial Concurrent iRTFor 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 | initial iRT for de novo metastatic NSCLC, initial iRT for locally advanced NSCLC |
| RT with maintenance of ICIFor post-treatment progressive NSCLC, salvage radiotherapy performed during immunotherapy. | Drug | Salvage iRT in post-treatment progressive NSCLC |
| RT after discontinuation of ICIFor post-treatment progressive NSCLC, salvage radiotherapy performed during within 90 days after the cessation of immunotherapy. | Drug | Salvage iRT in post-treatment progressive NSCLC |
Primary outcome
OS (overall survival)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer Non-Small Cell Cancer (NSCLC), run by Fengming Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (overall survival) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.