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

Tianjin Medical University Cancer Institute and Hospital0 sites30 target enrollmentMay 1, 2023

ConditionsNon Small Cell Lung Cancer Recurrent

InterventionsToripalimab, Anlotinib and Chemotherapy

DrugsToripalimab, Anlotinib and Chemotherapy

Overview

Phase: Phase 2
Intervention: Toripalimab, Anlotinib and Chemotherapy
Conditions: Non Small Cell Lung Cancer Recurrent
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Enrollment: 30
Primary Endpoint: Progress free survival
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

May 1, 2023

End Date

November 1, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Responsible Party

Sponsor

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.

Arms & Interventions

Toripalimab, Chemotherapy and Antiangiogenic Agents

Intervention: Toripalimab, Anlotinib and Chemotherapy

Outcomes

Primary Outcomes

Progress free survival

Time Frame: until Progressive Disease (PD) or death (up to 24 months)

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.

Secondary Outcomes

Objective Response Rate(each 21 days up to intolerance the toxicity or PD (up to 24 months))
Overall Survival(from first dose of study treatment until death (up to 24 months))
Disease Control Rate(each 21 days up to intolerance the toxicity or PD (up to 24 months))