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

NCT05842018 | Unknown Phase 2

• 1 other identifier: JS001-NSCLC-CO396
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

Study Arms (1)

Toripalimab, Chemotherapy and Antiangiogenic Agents

EXPERIMENTAL

Drug: Toripalimab, Anlotinib and Chemotherapy

Interventions

Toripalimab, Anlotinib and Chemotherapy 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.

Also known as: JS001

Toripalimab, Chemotherapy and Antiangiogenic Agents

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Active, known or suspected autoimmune disease;
• Active or chronic hepatitis C or/and hepatitis B infection;
• History of interstitial lung disease.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Interventions

toripalimab; anlotinib; Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Dongying Liu

CONTACT

+86 022 23340123; ldytjnk@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 3, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share