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

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-11-01

Brief 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)

Conditions

Non Small Cell Lung Cancer Recurrent

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Toripalimab, Chemotherapy and Antiangiogenic Agents

Group Type: EXPERIMENTAL

Toripalimab, Anlotinib and Chemotherapy

Intervention Type: DRUG

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.

Interventions

Toripalimab, Anlotinib and Chemotherapy

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.

Intervention Type: DRUG

Other Intervention Names

JS001

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Dongying Liu

Role: CONTACT

ldytjnk@sina.com

+86 022 23340123 ext. 1157

Other Identifiers

JS001-NSCLC-CO396

Identifier Type: -

Identifier Source: org_study_id