NSCLC Stage IVPhase 2MWA in NSCLCNCT04102982
Microwave Ablation in Combination With Camrelizumab Versus Camrelizumab in Metastatic Non-small-cell Lung Cancer
A Phase 2 study testing Camrelizumab and Camrelizumab plus microwave ablation in people with NSCLC Stage IV, run by Shandong Provincial Hospital at 13 sites in China.
Trial summary
Patients were randomized to microwave ablation plus camrelizumab group or camrelizumab group. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- NSCLC Stage IV
- What is being tested?
- Camrelizumab and Camrelizumab plus microwave ablation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 13 sitesChina
- Study dates
- 1 Nov 2019to 28 Feb 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years old
- Cytologically or pathologically verified non-small cell lung cancer (NSCLC)
- Patients with distant metastases or postoperative recurrence
- EGFR or ALK sensitive mutations are negative (all patients, including non-adenocarcinoma patients)
- At least one line of platinum-based doublet chemotherapy was administrated
- Eastern Cancer Cooperative Group（ECOG）Performance Status（PS）of 0 to 1
Show all 10Show fewer
- At least two measurable tumors (in other words a measurable tumor lesion exclusive primary tumors)
- Asymptomatic brain metastases or symptomatic brain metastases under control
- If treated with irradiation，at least one month interval between radiation and randomization 10）Cardiopulmonary function, laboratory test indicators without ablation or chemotherapy contraindications
- 11) Informed conssent can be obtained 12) Sufficient tissue specimens for PD-L1 or TMB or blood samples were provided (1 week before treatment, 1 week after ablation, and once every two months for immune evaluation) for subsequent analysis
Who cannot join
- Mixed lung cancer contains neuroendocrine tumor, small cell lung cancer or sarcoma
- Suffering from other malignant tumors within five years
- EGFR, ALK sensitive mutations are positive or unknown
- ECOG PS≥2
- Uncontrolled pleural effusion or pericardial effusion
- Uncontrolled symptomatic brain metastases
Show all 14Show fewer
- Previously anti-PD-1, anti-PD-L1, anti-CTLA-4 or Car-T immunotherapy
- severe interstitial pneumonia with severe diffuse dysfunction
- Autoimmune diseases require long-term hormone therapy patients
- Patients required consistent application of prednisone
- Uncontrolled pulmonary infection or antibiotics stopped within 1 month
- Acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 1 month
- Patients during pregnancy or lactation
- Life expectance of 3 months or less
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Binzhou Medical University Hospital
Binzhou, Shandong, +86 256600
Shao shui Chen, M.D, +86 15169959936, byfychenss@126.com
- Recruiting
Dezhou People's Hospital
Dezhou, Shandong, +86 253000
Yu ting Dong, +86 13969286066, dyt1963@163.com
- Recruiting
The Second People's Hospital of Dezhou
Dezhou, Shandong, +86 253000
Chun tang Wang, M.D, +86 13181378288, dzeyxwct@sina.com
- Recruiting
Jinan Military General Hospital
Jinan, Shandong, +83 250001
Jing wang Bi, M.D, +86 15963119538, jingwangbi@outlook.com
- Recruiting
Affliated Hospital of Shandong Academy of Medical Sciences
Jinan, Shandong, +86 250001
Ya hong Sun, M.D, 13606415915, sunyahong0915@163.com
- Recruiting
Shandong Provincial Hospital affliated to Shandong University
Jinan, Shandong, +86053168773172
Xin Ye, M.D., +86 0531 68773172, yexintaian2014@163.com
gang Z Wei, M.D., +86 0531 68773171, weizhigang321321@163.com
- Recruiting
Affliated Hospital of Jining Medical University
Jining, Shandong, +86 272000
Jun ye Wang, M.D, +86 13563771996, jiningwangjunye@163.com
- Recruiting
Liaocheng Cancer Hospital
Liaocheng, Shandong, +86 252000
Qing liang Feng, M.D, +86 15339949567, fql-123@sohu.com
- Recruiting
Affliated Hospital of Taishan Medical University
Taian, Shandong, +86 271000
Ben hua Zhang, M.D, +86 15169887577, zhangbenhua1964@163.com
- Recruiting
The People's Liberation Army 88 Hospital
Taian, Shandong, +86 271000
Li cheng Zhang, M.D, +86 13605383651, zhanglc88@aliyun.com
- Recruiting
Weifang People's Hospital
Weifang, Shandong, +86 262000
Guo hua Yu, M.D, +86 13685368817, ghyry@126.com
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, +86 264000
Liang ming Zhang, M.D, +86 18660079893, zhanglmdr@163.com
- Recruiting
Tengzhou center of people's hospital
Zaozhuang, Shandong, +86 277000
Kai xian Zhang, M.D, +86 18663069829, kaixianzhang@aliyun.com
About this study
Official title: Shandong Provincial Hospital Affiliated to Shandong University
Patients were randomized to microwave ablation plus camrelizumab group or camrelizumab group.
Read the detailed description
Patients in the camrelizumab group were treated with camrelizumab with the dose of 200mg on day 1, repeated every 21 days.Patients in the combination group were treated with MWA in the primary tumor followed by camrelizumab with the dose of 200mg on day 1, repeated every 21 days.
The primary end point is overall survival. The second end points include progression free survival, objective response rate and safety.
- Conditions
- NSCLC Stage IV
- Being tested
- Camrelizumab, Camrelizumab plus microwave ablation
- Keywords
- NSCLC, Camrelizumab, Microwave ablation, Overall survival, Progression free survival, Objective response rate, Safety
- 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.
CamrelizumabDrug
Patients will be treated with camrelizumab alone.
Camrelizumab plus microwave ablationOther
Also called Camrelizumab plus MWA
In the group, microwave ablation will be administrated to the primary tumors, followed by camrelizumab.
| Study group | Role | What they receive |
|---|---|---|
| Microwave ablation plus camrelizumab group | Active comparator | Patients in the group are treated with Microwave ablation in the primary tumor, followed by camrelizumab. Receives: Other: Camrelizumab plus microwave ablation |
| Camrelizumab group | Placebo comparator | Patients in the group are treated with camrelizumab alone. Receives: Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
ORR
Measured: The proportion of Patients achieved complete response or partial response up to 16 weeks
Secondary outcomes (3)
Overall survival
OS
Measured: From date of randomization until the date of first documented date of death from any cause，assessed up to 24 months
Progression free survival
OS
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Safety
The adverse events of both microwave and camrelizumab
Measured: The proportion and grade of patients had adverse events up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start1 Nov 2019
- Primary completion31 Oct 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IVStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1：Patients in the combination group were treated with MWA in the primary tumor followed by camrelizumab with the dose of 200mg on day 1, repeated every 21 days. Arm 2：Patients in the camrelizumab group were treated with camrelizumab with the dose of 200mg on day 1, repeated every 21 days.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xin Ye, Shandong Provincial Hospital
- Investigators
- Xin Ye, Principal investigator, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102982
- Sponsor's protocol ID
- Shandong PH
- Acronym
- MWA in NSCLC
- Status last verified
- Oct 2020
- First submitted
- 22 Sep 2019
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Principle of confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shandong Provincial Hospital Affiliated to Shandong University
- ClinicalTrials.gov ID
- NCT04102982
- Acronym / sponsor ID
- MWA in NSCLC / Shandong PH
- Conditions
- NSCLC Stage IV
- Keywords
- NSCLC, Camrelizumab, Microwave ablation, Overall survival, Progression free survival, Objective response rate, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 25 Sep 2019 (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.
Patients were randomized to microwave ablation plus camrelizumab group or camrelizumab group.
Detailed description
Patients in the camrelizumab group were treated with camrelizumab with the dose of 200mg on day 1, repeated every 21 days.Patients in the combination group were treated with MWA in the primary tumor followed by camrelizumab with the dose of 200mg on day 1, repeated every 21 days.
The primary end point is overall survival. The second end points include progression free survival, objective response rate and safety.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm 1：Patients in the combination group were treated with MWA in the primary tumor followed by camrelizumab with the dose of 200mg on day 1, repeated every 21 days. Arm 2：Patients in the camrelizumab group were treated with camrelizumab with the dose of 200mg on day 1, repeated every 21 days.
| Arm | Type | Receives |
|---|---|---|
| Microwave ablation plus camrelizumab group | Active comparator | Other: Camrelizumab plus microwave ablationPatients in the group are treated with Microwave ablation in the primary tumor, followed by camrelizumab. |
| Camrelizumab group | Placebo comparator | Drug: CamrelizumabPatients in the group are treated with camrelizumab alone. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18 to 75 years old
- Cytologically or pathologically verified non-small cell lung cancer (NSCLC)
- Patients with distant metastases or postoperative recurrence
- EGFR or ALK sensitive mutations are negative (all patients, including non-adenocarcinoma patients)
- At least one line of platinum-based doublet chemotherapy was administrated
Key exclusion criteria (14 listed)
- Mixed lung cancer contains neuroendocrine tumor, small cell lung cancer or sarcoma
- Suffering from other malignant tumors within five years
- EGFR, ALK sensitive mutations are positive or unknown
- ECOG PS≥2
- Uncontrolled pleural effusion or pericardial effusion
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 |
|---|---|---|
| CamrelizumabPatients will be treated with camrelizumab alone. | Drug | Camrelizumab group |
| Camrelizumab plus microwave ablationAlso: Camrelizumab plus MWAIn the group, microwave ablation will be administrated to the primary tumors, followed by camrelizumab. | Other | Microwave ablation plus camrelizumab group |
Primary outcome
Objective response rate
Time frame: The proportion of Patients achieved complete response or partial response up to 16 weeks
ORR
3 secondary outcomes
Overall survival
Time frame: From date of randomization until the date of first documented date of death from any cause，assessed up to 24 months
Progression free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Safety
Time frame: The proportion and grade of patients had adverse events up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Individual participant dataSharing planned: No. Principle of confidentiality
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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.
Xin Ye principal investigator
Shandong Provincial Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab and Camrelizumab plus microwave ablation in people with NSCLC Stage IV, run by Shandong Provincial Hospital at 13 sites 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 10 inclusion and 14 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 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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. Some participants in this study may receive a placebo. 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?
Contact Xin Ye (+8653168773171, yexitaian2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: The proportion of Patients achieved complete response or partial response up to 16 weeks). 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 2 Nov 2020.