Status:
UNKNOWN
JS001 Combination Therapy in NSCLC Negative Driving Gene After First-line Chemotherapy.
Lead Sponsor:
Li Zhang, MD
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a phase II, open, single-center clinical study to evaluate the efficacy and safety of JS001 combined with Axitinib in the treatment of advanced non-small cell lung cancer without activated EGF...
Eligibility Criteria
Inclusion
- Signed the informed consent form (ICF);
- Recurrent or advanced stage Ⅲ B or IV non-small cell lung cancer tested for EGFR mutation and ALK, ROS1 fusion gene, and all the driving gene was negative.
- At least one measurable lesion (according to RECIST 1.1);
- Failure of previous first-line standard chemotherapy:
- Patients who agreed to provide previously stored tumor tissue specimens or fresh biopsies of tumor lesions
- Age 18-75 years old, regardless of gender;
- ECOG score 0-1;
- Expected survival time ≥ 3 months;
- Laboratory test value must show enough organ function
Exclusion
- Tumor histology or cytological pathology confirmed the presence of small cell lung cancer components, or sarcomatoid lesions;
- Those who did not have a driving gene test;
- Investigator believed that there was a clear bleeding tendency
- Subjects who are currently participating in and receiving treatment in other studies, less than 4 weeks
- Patients who had previously received second-line or more systemic chemotherapy for advanced NSCLC;
- Patients who had received hematopoietic stimulating factors, within one week before the start of the study.
- Uncontrollable or symptomatic hypercalcemia
- Within 6 months before receiving the study treatment, they received chest (lung) radiotherapy \> 30Gy, or received radiotherapy within 4 weeks or radiopharmaceuticals within 8 weeks, except for local palliative radiotherapy for bone metastases.
- The adverse reactions of previous antineoplastic therapy have not yet recovered to CTCAE 5.0 grade ≤ 1 (except alopecia);
- Major surgery or radiotherapy has been performed within 4 weeks before joining the group or has not yet fully recovered from the previous operation
- Known active central nervous system (CNS) metastasis and / or cancerous meningitis;
- Spinal cord compression without radical treatment of surgery and / or radiotherapy;
- Uncontrolled tumor-related pain;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage ;
- Evidence of active pneumonia was found;
- Clinically uncontrolled active infections;
- Uncontrollable major seizures or superior vena cava syndrome;
- Past or present co-existence of other malignant tumors;
- Liver diseases known to be of clinical significance;
- Those who have previously used any anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody and Axitinib;
- Patients with active tuberculosis (TB);
- Patients with any active autoimmune disease or history of autoimmune disease;
- Any anti-infective vaccine;
- Known (HIV) infection of human immunodeficiency virus;
- The researchers believe that it can affect study compliance;
- Patients who received systemic immunosuppressive drugs within the first 4 weeks of the first day of the first cycle;
- History of severe allergy, anaphylaxis or other hypersensitivity to chimeric or humanized antibodies or fusion proteins;
- Those who are known to be allergic to biological drugs;
- Those who are known to be allergic to acitinib;
- Patients with a history of arterial or venous thromboembolism;
- Known hereditary or acquired bleeding and thrombotic tendencies;
- Patients who have previously received allogeneic stem cell or parenchyma organ transplantation;
- Pregnant or lactating women or women of childbearing age who were positive for serum pregnancy test before taking the drug for the first time
Key Trial Info
Start Date :
August 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04459663
Start Date
August 31 2020
End Date
December 31 2023
Last Update
July 7 2020
Active Locations (1)
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1
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060