Non Small Cell Lung CancerPhase 2NCT05584267
Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy
A Phase 2 study testing radiotherapy and Chemotherapy + immunotherapy in people with Non Small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
Trial summary
This is a prospective multicenter clinical study. This study aims to construct an auxiliary decision-making system for lung cancer immunotherapy combined with radiotherapy by fusing three modes of imagomics, clinicopathological features, and molecular pathological features. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- radiotherapy and Chemotherapy + immunotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2022to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥ 18 years of age on day of signing informed consent
- Histopathology confirmed non-small cell lung cancer
- Asymptomatic brain metastases
- EGFR/ALK ROS1 driver gene mutation negative
- RECIST 1.1 based available assessment of lesions
- ECOG 0-1
- Brain metastases 1-4
- Single lesion ≤4cm
Who cannot join
- Patients with contraindication of chemotherapy Pregnant or breast feeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Yongchang Zhang, MD, +86 731 89762323, zhangyongchang@csu.edu.cn
Nong Yang, MD, +86 731 89762321, yangnong0217@163.com
About this study
Official title: Multi-omics Evaluation System and Preferred Mode of Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy
This is a prospective multicenter clinical study. This study aims to construct an auxiliary decision-making system for lung cancer immunotherapy combined with radiotherapy by fusing three modes of imagomics, clinicopathological features, and molecular pathological features.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- radiotherapy, Chemotherapy + immunotherapy
- 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.
radiotherapyRadiation
Different cohorts received different doses of radiotherapy
Chemotherapy + immunotherapyDrug
Chemotherapy + immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| cohort A | Active comparator | Chemotherapy + immunotherapy; Every three weeks, up to four cycles of chemotherapy Receives: Drug: Chemotherapy + immunotherapy |
| cohort B | Experimental | Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; WBRT, 3 Gy/ time, 10 times in total Receives: Radiation: radiotherapy; Drug: Chemotherapy + immunotherapy |
| cohort C | Experimental | Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; HFRT, 10 Gy/ time, 3 times in total Receives: Radiation: radiotherapy; Drug: Chemotherapy + immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial progression-free survival
assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI
Measured: up to 2 years from enrollment
sPFS
assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI
Measured: up to 2 years from enrollment
Secondary outcomes (3)
Objective Response rate
assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI
Measured: up to 2 years from enrollment
overall survival
the time from enrollment until death or the last follow-up
Measured: up to 2 years from enrollment
number of participants with treatment-related adverse events
number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: up to 2 years from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start25 Dec 2022
- Primary completion1 Nov 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongchang Zhang, Hunan Province Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584267
- Sponsor's protocol ID
- RENO
- Status last verified
- May 2024
- First submitted
- 14 Oct 2022
- Last updated
- 30 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-omics Evaluation System and Preferred Mode of Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy
- ClinicalTrials.gov ID
- NCT05584267
- Acronym / sponsor ID
- RENO
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 25 Dec 2022 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Oct 2022 (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.
This is a prospective multicenter clinical study. This study aims to construct an auxiliary decision-making system for lung cancer immunotherapy combined with radiotherapy by fusing three modes of imagomics, clinicopathological features, and molecular pathological features.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cohort A | Active comparator | Drug: Chemotherapy + immunotherapyChemotherapy + immunotherapy; Every three weeks, up to four cycles of chemotherapy |
| cohort B | Experimental | Radiation: radiotherapy, Drug: Chemotherapy + immunotherapyChemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; WBRT, 3 Gy/ time, 10 times in total |
| cohort C | Experimental | Radiation: radiotherapy, Drug: Chemotherapy + immunotherapyChemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; HFRT, 10 Gy/ time, 3 times in total |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years of age on day of signing informed consent
- Histopathology confirmed non-small cell lung cancer
- Asymptomatic brain metastases
- EGFR/ALK ROS1 driver gene mutation negative
- RECIST 1.1 based available assessment of lesions
Key exclusion criteria (1 listed)
- Patients with contraindication of chemotherapy Pregnant or breast feeding women
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 |
|---|---|---|
| radiotherapyDifferent cohorts received different doses of radiotherapy | Radiation | cohort B, cohort C |
| Chemotherapy + immunotherapyChemotherapy + immunotherapy | Drug | cohort A, cohort B, cohort C |
Primary outcome
Intracranial progression-free survival
Time frame: up to 2 years from enrollment
assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI
sPFS
Time frame: up to 2 years from enrollment
assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI
3 secondary outcomes
Objective Response rate
Time frame: up to 2 years from enrollment
overall survival
Time frame: up to 2 years from enrollment
number of participants with treatment-related adverse events
Time frame: up to 2 years from enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing radiotherapy and Chemotherapy + immunotherapy in people with Non Small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
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 8 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 30 May 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 China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongchang C Zhang, MD (+8613873123436 ext. 7+861383123436, zhangyongchang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial progression-free survival (time frame: up to 2 years from enrollment). The study lists 2 primary outcomes in all. 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 30 May 2024.