NSCLC Stage IVPhase 2NCT04291092
Camrelizumab Combined With Local Treatment in NSCLC Patients With BM
A Phase 2 study testing Immunotherapy, WBRT and Chemotherapy in people with NSCLC Stage IV and Brain Metastases, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Camrelizumab Combined with Chemotherapy and Local Treatment in non-small cell lung cancer with brain metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Stage IV, Brain Metastases, Immunotherapy
- What is being tested?
- Immunotherapy, WBRT and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Jun 2023
- Phase
- Phase 2
- 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
Who may be able to join
- Age ≥18;
- ECOG is 0-1;
- Non-small cell lung cancer confirmed by histology; EGFR、ALK and ROS1 negative;
- The presence of brain metastases as determined by imaging, with unlimited numbers, the intracranial lesions had a maximum diameter of ≥ 0.5cm，allowing the presence of clinical symptoms of brain metastases;
- According to RECIST 1.1, there is at least one measurable extracranial and intracranial target lesion each;
- Sign informed consent and agree to collect the clinical efficacy and information of the patient.
Who cannot join
- Immunotherapeutic contraindications (including long-term use of hormones, history of radiation pneumonia, etc.)
- Active autoimmune diseases (e.g. vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.)
- Patients with active hepatitis B or C, HIV, active tuberculosis, etc.;
- Active infections requiring antimicrobial therapy (e.g. antimicrobial, antiviral, antifungal);
- History of known allogeneic organ transplantation and history of in vivo hematopoietic stem cell transplantation;
- Patients with interstitial lung disease or previous history of interstitial pneumonia;
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- Having a history of substance abuse and unable to abstain from it or having mental disorders;
- who have participated in other clinical trials of antitumor drugs within 4 weeks before entering the group;
- Having used PD-1/PD-L1 and other immunotherapy drugs before entering the group;
- previous or concurrent with other untreated malignancies, except for cured basal cell carcinoma of the skin, carcinoma of the cervix in situ and superficial bladder cancer;
- (a) Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraception;
- The researchers judged other situations that might affect the conduct of clinical studies and the determination of their findings.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Yun Fan, Dr, +86 057188122092, fanyun@zjcc.org.cn
About this study
Official title: Camrelizumab Combined With Chemotherapy and Local Treatment in Non-small Cell Lung Cancer Patients With Brain Metastasis, a Single-arm, Multi-center, Open-labeled Phase II Clinical Trial
To evaluate the efficacy and safety of Camrelizumab Combined with Chemotherapy and Local Treatment in non-small cell lung cancer with brain metastases.
Read the detailed description
To evaluate the efficacy and safety of Camrelizumab Combined with Chemotherapy and Local Treatment of brain metastases (WBRT, r-knife, SRS, etc.) in non-small cell lung cancer patients with brain metastases .
- Conditions
- NSCLC Stage IV, Brain Metastases, Immunotherapy
- Being tested
- Immunotherapy, WBRT, Chemotherapy
- Keywords
- lung cancer, Brain Metastases, Camrelizumab, WBRT, SRS
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunotherapyDrug
Also called Camrelizumab
Immunotherapy for brain metastasis
WBRTRadiation
Also called SRS
local therapy for brain metastasis
ChemotherapyDrug
Chemotherapy for brain metastasis
| Study group | Role | What they receive |
|---|---|---|
| single-arm | Experimental | single-arm Receives: Drug: Immunotherapy; Radiation: WBRT; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 month progression-free survival rate
6 month progression-free survival rate
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start1 Jan 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NSCLC Stage IVStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GongLei, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291092
- Sponsor's protocol ID
- XYJ20200101-1
- Status last verified
- Aug 2021
- First submitted
- 8 Jan 2020
- Last updated
- 10 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xu Y, Chen K, Xu Y, Li H, Huang Z, Lu H, Huang D, Yu S, Han N, Gong L, Qin J, Chen J, Xie F, Hong W, Lin X, Cheng F, Luo X, Fan Y. Brain radiotherapy combined with camrelizumab and platinum-doublet chemotherapy for previously untreated advanced non-small-cell lung cancer with brain metastases (C-Brain): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2025 Jan;26(1):74-84. doi: 10.1016/S1470-2045(24)00643-0.
PubMed 39756446
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab Combined With Chemotherapy and Local Treatment in Non-small Cell Lung Cancer Patients With Brain Metastasis, a Single-arm, Multi-center, Open-labeled Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT04291092
- Acronym / sponsor ID
- XYJ20200101-1
- Conditions
- NSCLC Stage IV, Brain Metastases, Immunotherapy
- Keywords
- lung cancer, Brain Metastases, Camrelizumab, WBRT, SRS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 2 Mar 2020 (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.
To evaluate the efficacy and safety of Camrelizumab Combined with Chemotherapy and Local Treatment in non-small cell lung cancer with brain metastases.
Detailed description
To evaluate the efficacy and safety of Camrelizumab Combined with Chemotherapy and Local Treatment of brain metastases (WBRT, r-knife, SRS, etc.) in non-small cell lung cancer patients with brain metastases .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-arm | Experimental | Drug: Immunotherapy, Radiation: WBRT, Drug: Chemotherapysingle-arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18;
- ECOG is 0-1;
- Non-small cell lung cancer confirmed by histology; EGFR、ALK and ROS1 negative;
- The presence of brain metastases as determined by imaging, with unlimited numbers, the intracranial lesions had a maximum diameter of ≥ 0.5cm，allowing the presence of clinical symptoms of brain metastases;
- According to RECIST 1.1, there is at least one measurable extracranial and intracranial target lesion each;
Key exclusion criteria (12 listed)
- Immunotherapeutic contraindications (including long-term use of hormones, history of radiation pneumonia, etc.)
- Active autoimmune diseases (e.g. vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.)
- Patients with active hepatitis B or C, HIV, active tuberculosis, etc.;
- Active infections requiring antimicrobial therapy (e.g. antimicrobial, antiviral, antifungal);
- History of known allogeneic organ transplantation and history of in vivo hematopoietic stem cell transplantation;
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 |
|---|---|---|
| ImmunotherapyAlso: CamrelizumabImmunotherapy for brain metastasis | Drug | single-arm |
| WBRTAlso: SRSlocal therapy for brain metastasis | Radiation | single-arm |
| ChemotherapyChemotherapy for brain metastasis | Drug | single-arm |
Primary outcome
6 month progression-free survival rate
Time frame: 6 month
6 month progression-free survival rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Derived from this study: PubMed 39756446Xu Y, Chen K, Xu Y, Li H, Huang Z, Lu H, Huang D, Yu S, Han N, Gong L, Qin J, Chen J, Xie F, Hong W, Lin X, Cheng F, Luo X, Fan Y. Brain radiotherapy combined with camrelizumab and platinum-doublet chemotherapy for previously untreated advanced non-small-cell lung cancer with brain metastases (C-Brain): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2025 Jan;26(1):74-84. doi: 10.1016/S1470-2045(24)00643-0.
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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?
A Phase 2 study testing Immunotherapy, WBRT and Chemotherapy in people with NSCLC Stage IV and Brain Metastases, run by Zhejiang Cancer 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 6 inclusion and 12 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 10 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 month progression-free survival rate (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04291092, which also lists 1 linked publication.
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 10 Sep 2021.