Clinical trial NCT04102982: Microwave Ablation in Combination With Camrelizumab Versus Camrelizumab in Metastatic Non-small-cell Lung Cancer
Official title: Shandong Provincial Hospital Affiliated to Shandong University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: NSCLC Stage IV
Keywords: NSCLC
Camrelizumab
Microwave ablation
Overall survival
Progression free survival
Objective response rate
Safety
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2019-09-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 to 75 years old
2. Cytologically or pathologically verified non-small cell lung cancer (NSCLC)
3. Patients with distant metastases or postoperative recurrence
4. EGFR or ALK sensitive mutations are negative (all patients, including non-adenocarcinoma patients)
5. At least one line of platinum-based doublet chemotherapy was administrated
6. Eastern Cancer Cooperative Group（ECOG）Performance Status（PS）of 0 to 1
7. At least two measurable tumors (in other words a measurable tumor lesion exclusive primary tumors)
8. Asymptomatic brain metastases or symptomatic brain metastases under control
9. 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

Exclusion Criteria:

1. Mixed lung cancer contains neuroendocrine tumor, small cell lung cancer or sarcoma
2. Suffering from other malignant tumors within five years
3. EGFR, ALK sensitive mutations are positive or unknown
4. ECOG PS≥2
5. Uncontrolled pleural effusion or pericardial effusion
6. Uncontrolled symptomatic brain metastases
7. Previously anti-PD-1, anti-PD-L1, anti-CTLA-4 or Car-T immunotherapy
8. severe interstitial pneumonia with severe diffuse dysfunction
9. Autoimmune diseases require long-term hormone therapy patients
10. Patients required consistent application of prednisone
11. Uncontrolled pulmonary infection or antibiotics stopped within 1 month
12. Acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 1 month
13. Patients during pregnancy or lactation
14. Life expectance of 3 months or less

Primary outcomes:
measure: Objective response rate
timeFrame: The proportion of Patients achieved complete response or partial response up to 16 weeks
Secondary outcomes:
measure: Overall survival
timeFrame: From date of randomization until the date of first documented date of death from any cause，assessed up to 24 months
measure: Progression free survival
timeFrame: 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
measure: Safety
timeFrame: The proportion and grade of patients had adverse events up to 24 months
Other outcomes:
Locations:
city: Binzhou
country: China
facility: Binzhou Medical University Hospital
state: Shandong
city: Dezhou
country: China
facility: Dezhou People's Hospital
state: Shandong
city: Dezhou
country: China
facility: The Second People's Hospital of Dezhou
state: Shandong
city: Jinan
country: China
facility: Jinan Military General Hospital
state: Shandong
city: Jinan
country: China
facility: Affliated Hospital of Shandong Academy of Medical Sciences
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital affliated to Shandong University
state: Shandong
city: Jining
country: China
facility: Affliated Hospital of Jining Medical University
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng Cancer Hospital
state: Shandong
city: Taian
country: China
facility: Affliated Hospital of Taishan Medical University
state: Shandong
city: Taian
country: China
facility: The People's Liberation Army 88 Hospital
state: Shandong
city: Weifang
country: China
facility: Weifang People's Hospital
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Zaozhuang
country: China
facility: Tengzhou center of people's hospital
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: Xin Ye
role: PRINCIPAL_INVESTIGATOR
References: