Clinical trial NCT05842018: Toripalimab in Combination With Chemotherapy and Antiangiogenic Agents in Patients With Non-Small Cell Lung Cancer After Failure of Immunotherapy (PD-1/L1 Inhibitors)
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer Recurrent
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


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.

Primary outcomes:
measure: Progress free survival
timeFrame: until Progressive Disease (PD) or death (up to 24 months)
Secondary outcomes:
measure: Objective Response Rate
timeFrame: each 21 days up to intolerance the toxicity or PD (up to 24 months)
measure: Overall Survival
timeFrame: from first dose of study treatment until death (up to 24 months)
measure: Disease Control Rate
timeFrame: each 21 days up to intolerance the toxicity or PD (up to 24 months)
Other outcomes:
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Study officials:
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