Non-small Cell Lung Cancer MetastaticNCT05638425
Radiotherapy Combined With PD-1 Inhibitors and Chemotherapy in the Treatment of NSCLC Patients With Symptomatic Brain Metastases
An observational study of Non-small Cell Lung Cancer Metastatic and Brain Metastases, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This is a prospective, single-center observational clinical study aimed at the efficacy and safety of radiotherapy combined with PD-1 inhibitors and chemotherapy in the treatment of Chinese patients with symptomatic NSCLC with brain metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Metastatic, Brain Metastases
- What is being tested?
- Radiotherapy combined with PD-1 inhibitors
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2021to 31 Dec 2025
- 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: NSCLC Patients With Symptomatic Brain Metastases
Who may be able to join
- 1. Age ≥ 18 years old; patients with metastatic NSCLC with at least one measurable brain metastases, the longest diameter of the brain metastases is 0.5 to 3 cm, and the brain metastases have not received radiotherapy; stable neurological symptoms and/or are receiving Corticosteroid therapy. In addition, the following conditions are raised:
- Patients with negative driver-gene mutations who have not received systemic treatment before, and patients who have progressed after receiving neoadjuvant or adjuvant therapy, and the interval between disease progression or recurrence and the end of the last chemotherapy drug treatment is at least 6 months, and is allowed to enter this study;
- Patients with known EGFR sensitive mutation, ALK rearrangement or ROS1 fusion must have received at least one EGFR or ALK, ROS1 fusion inhibitor treatment and had disease progression or drug intolerance.
- Subjects with neurological symptoms can receive dexamethasone within 10 days before the first treatment, but the total daily dose is stable at no more than 4 mg or other Corticosteroids at the same dose. Subjects with neurologic symptoms but not receiving steroids should experience no seizures within 10 days prior to first treatment.
- 2. For patients with non-brain oligometastases, according to Response Evaluation Criteria in Solid Tumors Version 1.1 (mRECIST v1.1), there is at least 1 measurable or evaluable lesion in addition to brain metastases.
- 3. The Eastern Cooperative Oncology Group Physical Status Score (ECOG PS score) is 0-2 points.
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- 4. The patient has a clear mind, can answer correctly, and has basically normal vision, etc., and can cooperate with cognitive function assessment 5. Expected survival time ≥ 12 weeks. 6. The patient has adequate organ and bone marrow functions, as defined below:
- Blood routine: absolute neutrophil count ≥1.5×109/L; platelet count ≥100×109/L; hemoglobin content ≥9.0 g/dL.
- Liver function: serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); for patients with HCC, liver metastases, or a history/suspect of Gilbert syndrome (persistent or recurrent hyperbilirubinemia , mainly high unconjugated bilirubin, no evidence of hemolysis or liver disease), TBIL ≤ 3 × ULN; for patients without HCC and liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; for patients with HCC or with liver metastases, ALT or AST ≤ 5 × ULN.
- Renal function: serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance (CCr) ≥ 50mL/min; urine test paper test results show urine protein <2+.
- Coagulation function: activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5×ULN.
Who cannot join
- Receive live attenuated vaccine within 4 weeks before enrollment or plan to receive live attenuated vaccine during the study.
- Active, known or suspected autoimmune disease.
- Known history of primary immunodeficiency.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Female patients who are pregnant or breastfeeding.
- Untreated acute or chronic active hepatitis B or hepatitis C infection. Patients who are receiving antiviral treatment will be judged by doctors according to the individual conditions of the patients under the condition of monitoring the virus copy number.
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- History of dementia, Alzheimer's disease, Parkinson's disease and other diseases that can cause cognitive dysfunction
- History of schizophrenia, severe anxiety, depression, or other mental illnesses
- Uncontrolled concurrent diseases, including but not limited to:
- HIV-infected persons (HIV antibody positive).
- Serious infection that is active or poorly controlled clinically.
- Serious or uncontrolled systemic disease (such as severe mental, neurological disease, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, hepatic or renal disease, uncontrolled hypertension [i.e. Evidence of greater than or equal to CTCAE grade 2 hypertension after drug treatment]).
- Active bleeding or new thrombotic disease is taking therapeutic dose of anticoagulant drugs or bleeding tendency
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital, Central South University
Changsha, Hunan
Rongrong Zhou, +8613875898127, zhourr@csu.edu.cn
About this study
Official title: An Observational Study on the Efficacy and Safety of Radiotherapy Combined With PD-1 Inhibitors and Chemotherapy in the Treatment of NSCLC Patients With Symptomatic Brain Metastases
This is a prospective, single-center observational clinical study aimed at the efficacy and safety of radiotherapy combined with PD-1 inhibitors and chemotherapy in the treatment of Chinese patients with symptomatic NSCLC with brain metastases.
Read the detailed description
Radiotherapy is carried out within 4 weeks after the first dose of PD-1 inhibitor; radiotherapy is determined according to the patient's condition; the use of PD-1 inhibitors and chemotherapy is based on the actual product instructions.
From December 2021 to December 2023, after the patients signed the informed consent, they will be included in this observational study after being assessed as meeting the inclusion criteria. A total of 20 cases are planned to be included for research analysis. All eligible patients meeting the inclusion and exclusion criteria will be invited to participate in this study. Patients included in the study will be solicited to allow efficacy evaluation and survival follow-up during the study and after treatment. Patients were considered to be on study unless the patient died, was withdrawn from the study, was lost to follow-up, or the study was terminated. Patients do not need to visit a doctor or receive evaluation specifically because of the study, and the study doctor evaluates the patients based on clinical practice.
Since this study is an observational study, the diagnosis and treatment process listed in the protocol is a clinically recommended process and is not mandatory. Treatment and clinical visit schedules for enrolled patients were determined by clinicians based on routine practice. This study collects patient information, including safety and efficacy data, based on routine diagnosis and treatment procedures. Although the protocol does not mandate clinical visits, physicians are encouraged to follow up patients who have not been seen for at least 6 months to collect treatment-related data and determine patient survival. Patients will be considered lost to follow-up if they have not been seen for at least 1 year.
- Being tested
- Radiotherapy combined with PD-1 inhibitors
- Keywords
- radiotherapy, PD-1, symptomatic brain metastases, non-small cell lung cancer
- Medical subject headings
- Brain Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy combined with PD-1 inhibitorsRadiation
Radiotherapy should be carried out within 4 weeks after the first dose of PD-1 inhibitor; the radiotherapy method should be determined according to the patient's condition; PD-1 inhibitor and chemotherapy should refer to the actual product instructions
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Radiation: Radiotherapy combined with PD-1 inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial clinical benefit rate (CBR)
Measured: 6 months
Intracranial progression-free survival (PFS)
Measured: 1 year
Secondary outcomes (11)
Intracranial objective response rate (ORR)
Measured: 1 year
Extracranial clinical benefit rate (CBR)
Measured: 1 year
Extracranial objective response rate (ORR)
Measured: 1 year
Extracranial progression-free survival (PFS)
Measured: 1 year
Clinical benefit rate (CBR)
Measured: 1 year
Objective response rate (ORR)
Measured: 1 year
Progression-free survival (PFS)
Measured: 1 year
Overall survival (OS)
Measured: 1 year
Incidence of neurological adverse events
Measured: 1 year
Incidence of severe adverse events
Measured: 1 year
Rate of decline in cognitive function
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start31 Dec 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (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 Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Wu Jieping Medical Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638425
- Sponsor's protocol ID
- ESRCPIC
- Status last verified
- Nov 2022
- First submitted
- 27 Nov 2022
- Last updated
- 6 Dec 2022
- Results posted
- 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 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on the Efficacy and Safety of Radiotherapy Combined With PD-1 Inhibitors and Chemotherapy in the Treatment of NSCLC Patients With Symptomatic Brain Metastases
- ClinicalTrials.gov ID
- NCT05638425
- Acronym / sponsor ID
- ESRCPIC
- Keywords
- radiotherapy, PD-1, symptomatic brain metastases, non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Wu Jieping Medical Foundation
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Dec 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, single-center observational clinical study aimed at the efficacy and safety of radiotherapy combined with PD-1 inhibitors and chemotherapy in the treatment of Chinese patients with symptomatic NSCLC with brain metastases.
Detailed description
Radiotherapy is carried out within 4 weeks after the first dose of PD-1 inhibitor; radiotherapy is determined according to the patient's condition; the use of PD-1 inhibitors and chemotherapy is based on the actual product instructions.
From December 2021 to December 2023, after the patients signed the informed consent, they will be included in this observational study after being assessed as meeting the inclusion criteria. A total of 20 cases are planned to be included for research analysis. All eligible patients meeting the inclusion and exclusion criteria will be invited to participate in this study. Patients included in the study will be solicited to allow efficacy evaluation and survival follow-up during the study and after treatment. Patients were considered to be on study unless the patient died, was withdrawn from the study, was lost to follow-up, or the study was terminated. Patients do not need to visit a doctor or receive evaluation specifically because of the study, and the study doctor evaluates the patients based on clinical practice.
Since this study is an observational study, the diagnosis and treatment process listed in the protocol is a clinically recommended process and is not mandatory. Treatment and clinical visit schedules for enrolled patients were determined by clinicians based on routine practice. This study collects patient information, including safety and efficacy data, based on routine diagnosis and treatment procedures. Although the protocol does not mandate clinical visits, physicians are encouraged to follow up patients who have not been seen for at least 6 months to collect treatment-related data and determine patient survival. Patients will be considered lost to follow-up if they have not been seen for at least 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Radiation: Radiotherapy combined with PD-1 inhibitors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NSCLC Patients With Symptomatic Brain Metastases
Key inclusion criteria (11 listed)
- 1. Age ≥ 18 years old; patients with metastatic NSCLC with at least one measurable brain metastases, the longest diameter of the brain metastases is 0.5 to 3 cm, and the brain metastases have not received radiotherapy; stable neurological symptoms and/or are receiving Corticosteroid therapy. In addition, the following conditions are raised:
- Patients with negative driver-gene mutations who have not received systemic treatment before, and patients who have progressed after receiving neoadjuvant or adjuvant therapy, and the interval between disease progression or recurrence and the end of the last chemotherapy drug treatment is at least 6 months, and is allowed to enter this study;
- Patients with known EGFR sensitive mutation, ALK rearrangement or ROS1 fusion must have received at least one EGFR or ALK, ROS1 fusion inhibitor treatment and had disease progression or drug intolerance.
- Subjects with neurological symptoms can receive dexamethasone within 10 days before the first treatment, but the total daily dose is stable at no more than 4 mg or other Corticosteroids at the same dose. Subjects with neurologic symptoms but not receiving steroids should experience no seizures within 10 days prior to first treatment.
- 2. For patients with non-brain oligometastases, according to Response Evaluation Criteria in Solid Tumors Version 1.1 (mRECIST v1.1), there is at least 1 measurable or evaluable lesion in addition to brain metastases.
Key exclusion criteria (13 listed)
- Receive live attenuated vaccine within 4 weeks before enrollment or plan to receive live attenuated vaccine during the study.
- Active, known or suspected autoimmune disease.
- Known history of primary immunodeficiency.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Female patients who are pregnant or breastfeeding.
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 |
|---|---|---|
| Radiotherapy combined with PD-1 inhibitorsRadiotherapy should be carried out within 4 weeks after the first dose of PD-1 inhibitor; the radiotherapy method should be determined according to the patient's condition; PD-1 inhibitor and chemotherapy should refer to the actual product instructions | Radiation | Group 1 |
Primary outcome
Intracranial clinical benefit rate (CBR)
Time frame: 6 months
Intracranial progression-free survival (PFS)
Time frame: 1 year
11 secondary outcomes
Intracranial objective response rate (ORR)
Time frame: 1 year
Extracranial clinical benefit rate (CBR)
Time frame: 1 year
Extracranial objective response rate (ORR)
Time frame: 1 year
Extracranial progression-free survival (PFS)
Time frame: 1 year
Clinical benefit rate (CBR)
Time frame: 1 year
Objective response rate (ORR)
Time frame: 1 year
Progression-free survival (PFS)
Time frame: 1 year
Overall survival (OS)
Time frame: 1 year
Incidence of neurological adverse events
Time frame: 1 year
Incidence of severe adverse events
Time frame: 1 year
Rate of decline in cognitive function
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- 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.
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 Non-small Cell Lung Cancer Metastatic and Brain Metastases, run by Xiangya Hospital of Central South University 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 11 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 6 Dec 2022. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongrong Zhou (+86 13875898127, zhourr@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial clinical benefit rate (CBR) (time frame: 6 months). 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 6 Dec 2022.