Toripalimab in Combination With Chemotherapy and Antiangiogenic Agents in Patients With Non-Small Cell Lung Cancer After Failure of Immunotherapy (PD-1/L1 Inhibitors)

Non Small Cell Lung Cancer Recurrent Clinical Trial

Official 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): a Prospective, Single-arm, Phase II Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05842018
• Other study ID #: JS001-NSCLC-CO396
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2023
• Est. completion date: November 1, 2025

Study information

• Verified date: March 2023
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Dongying Liu
• Phone: +86 022 23340123
• Email: ldytjnk[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer Recurrent

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress free survival	Progress free survival is defined as the time from first dose of study treatment until the first date of either disease progression or death due to any cause.	until Progressive Disease (PD) or death (up to 24 months)
Secondary	Objective Response Rate	Objective response rate is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.	each 21 days up to intolerance the toxicity or PD (up to 24 months)
Secondary	Overall Survival	Overall survival is defined as the time until death due to any cause.	from first dose of study treatment until death (up to 24 months)
Secondary	Disease Control Rate	Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.	each 21 days up to intolerance the toxicity or PD (up to 24 months)