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

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · Apr 24, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with non-small cell lung cancer (NSCLC) who have not responded to previous immunotherapy treatments. The study is testing Toripalimab, a type of medication that helps the immune system fight cancer, in combination with chemotherapy and other drugs that target blood vessel growth. This trial is in its early phase and aims to assess how effective and safe this combination therapy is for people with advanced stages of NSCLC.

To join the study, participants must be adults between the ages of 18 and 75 who have been diagnosed with locally advanced or metastatic NSCLC and have previously tried PD-1/PD-L1 inhibitors without success. Other requirements include having measurable cancer lesions and normal organ function. Participants can expect to receive the new treatment and will be closely monitored for safety and effectiveness. It’s important to note that this trial is not yet recruiting, so interested individuals will need to wait until enrollment begins.

Gender

ALL

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.