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Trial Title:
Toripalimab in Combination With Chemotherapy and Antiangiogenic Agents in Patients With Non-Small Cell Lung Cancer After Failure of Immunotherapy (PD-1/L1 Inhibitors)
NCT ID:
NCT05842018
Condition:
Non Small Cell Lung Cancer Recurrent
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Toripalimab, Anlotinib and Chemotherapy
Description:
Combination therapy:
Toripalimab 240mg will be intravenously administered on Day 1, Q3W; anlotinib: 12 mg qd
d1-d14, d15-d21 discontinued, Q3W; investigator selected chemotherapy regimen
(paclitaxel, pemetrexed or gemcitabine and other chemotherapeutic drugs which were not
administered in the first-line therapy) for a total of 4 cycles.
Maintenance therapy:
After combination therapy, Patients who achieved complete response（CR）, partial response
(PR), or stable disease (SD) were administered with toripalimab plus anlotinib as
maintenance therapy. until disease progression or intolerable toxicity, treatment for 2
years, investigator decision, withdrawal of consent, or death.
Arm group label:
Toripalimab, Chemotherapy and Antiangiogenic Agents
Other name:
JS001
Summary:
This is a phase II, single arm, open-label, single-center study to evaluate the efficacy
and safety of Toripalimab combined with Chemotherapy and Antiangiogenic Agents in
patients with Non-Small Cell Lung Cancer After Failure of Immunotherapy (PD-1/L1
inhibitors)
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients voluntarily participate in this study, signed and dated informed consent
with good compliance and follow-up;
- Diagnosed as locally advanced and / or metastatic non-small cell lung adenocarcinoma
(NSCLC) by cytology or histology;
- First-line PD-1/PD-L1 inhibitors treatment failure;
- Provide detectable specimens (tissue or blood) for genotyping before enrollment, and
the patients should be with negative EGFR and ALK gene test results;
- Had at least one measurable lesion according to RECIST 1.1 criteria
- Anticipated overall survival more than 3 months;
- ECOG (Eastern Cooperative Oncology Group) scale 0-2;
- Normal organ function and bone marrow function;
- Resistant to first-line immune checkpoint inhibitor therapy and discontinued for
more than 4 weeks;
- Women of childbearing age must have taken reliable contraceptive measures and
performed a pregnancy test (serum or urine) within 7 days prior to enrollment, and
the results were negative, and were willing to use appropriate methods during the
trial and 4 weeks after the last administration of the test drug.
Exclusion Criteria:
- Patients with small cell lung cancer (including small cell carcinoma and non-small
cell carcinoma mixed lung cancer) ;
- Patients who have previously permanently discontinued immunotherapy due to
immune-related serious adverse reactions;
- Patients who previously treated with antiangiogenic agents;
- A history of other malignancies within 5 years prior to inclusion, except for
cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate
cancer treated with radical surgery, and ductal carcinoma in situ treated with
radical surgery;
- Active, known or suspected autoimmune disease;
- Active or chronic hepatitis C or/and hepatitis B infection;
- History of interstitial lung disease.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
May 1, 2023
Completion date:
November 1, 2025
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05842018
