PD-L1-positive, driver mutation-negative advanced non-small cell lung cancer (NSCLC) with failure of first-line immunotherapy (as monotherapy or in combination with chemotherapy)
Conditions
Interventions
Treatment group:Stephania Longa and Jiezai Rice combined with Sintilimab
Sponsors
Hainan General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Sign a written informed consent form before undergoing any trial-related procedures; 2.Age >= 18 years old and = 1%); 7.At least one radiographically measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). Lesions located within a previously irradiated field that have demonstrated progression can be considered measurable; 8.Subjects with asymptomatic brain metastases or those whose symptoms have stabilized after local treatment are allowed to be enrolled, provided that they meet the following criteria: 1) There are measurable lesions outside the central nervous system (CNS); 2)There are no CNS symptoms or the symptoms have not worsened in at least the past 2 weeks; 3)They do not require glucocorticoid treatment, or have discontinued glucocorticoid therapy within 7 days prior to the first dose administration, or have maintained a stable and reduced dosage of glucocorticoids to below 10 mg/day of prednisone (or an equivalent dose) within 7 days prior to the first dose administration. 9.Subjects are allowed to receive palliative radiotherapy (including cranial radiotherapy for symptomatic brain metastases), provided that the radiotherapy is completed at least 1 week prior to enrollment, and any radiotherapy-related toxicities have resolved to grade <= 1 (as per CTCAE version 5.0, excluding alopecia); 10.ECOG performance status score of 0-2; 11.Adequate organ function, with subjects required to meet laboratory criteria; 12.For female subjects of childbearing potential, they should undergo a urine or serum pregnancy test within 3 days prior to receiving the first dose of the study drug (Day 1 of Cycle 1), and the result must be negative. If the urine pregnancy test result cannot be definitively confirmed as negative, a blood pregnancy test is required. Female subjects who are not of childbearing potential are defined as those who have been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy;
Exclusion criteria
Exclusion criteria: 1.The pathology is small cell lung cancer (SCLC), including mixed lung cancer with both SCLC and non-small cell lung cancer (NSCLC) components; 2.The patient has received more than one line of treatment with PD-(L)1 inhibitor monotherapy or in combination with chemotherapy; 3.The following treatments have been received: 1) Systemic anti-tumor therapy, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal medicine prescribed for anti-tumor indications), etc., within 3 weeks prior to treatment; 2)Any investigational drug therapy within 4 weeks prior to treatment; 3)High-dose immunosuppressive drugs (systemic glucocorticoids exceeding 10 mg/day of prednisone or its equivalent dose) within 4 weeks prior to treatment; 4)Live attenuated vaccines (or plans to receive live attenuated vaccines during the study period) within 4 weeks prior to treatment; 5)Major surgery (such as laparotomy, thoracotomy, or other extensive surgical procedures) within 4 weeks prior to treatment, or the presence of unhealed surgical wounds, ulcers, or fractures. 4.Presence of clinically uncontrollable pleural effusion/ascites (subjects who do not require drainage of the effusion or show no significant increase in effusion volume for 3 days after discontinuation of drainage may be enrolled); 5.Subjects who have received chest radiotherapy with a dose greater than 30 Gy within 6 months prior to treatment, or who have received palliative radiotherapy with a dose of 30 Gy or less within 7 days prior to treatment (palliative radiotherapy for bone lesions or intracranial lesions is permitted); 6.History of active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose administration. Replacement therapy (e.g., thyroxine, insulin, or physiologic doses of glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic treatment; 7.Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8.Known hypersensitivity to the study drug sintilimab, the active ingredients or excipients of Fengjidu and jiezai Mi (assuming this refers to a specific component or formulation; if not, adjust accordingly); 9.Failure to fully recover from toxicity and/or complications induced by any prior interventions prior to the initiation of treatment (i.e., toxicity reduced to = grade 1 or baseline, excluding fatigue or alopecia); 10.Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies); 11.Untreated active hepatitis B (defined as positive for HBsAg with detectable HBV-DNA copy numbers exceeding the upper limit of normal for the laboratory at the study center); 12.Subjects with active HCV infection (positive for HCV antibodies and HCV-RNA levels above the lower limit of detection); 13.Vaccination with a live vaccine within 30 days prior to the first dose administration (Day 1 of Cycle 1); Note: Administration of inactivated viral vaccines for seasonal influenza via injection is permitted within 30 days prior to the first dose; however, the administration of live attenuated influenza vaccines via intranasal route is not permitted; 14.Pregnant or lactating women; 15.Presence of any severe or uncontrolled systemic medical condition; 16.Evidence of a medical history, disease, treatment, or abnormal laboratory test value
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life;Safety;emotional distress;Disease Control Rate;Objective Response Rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactChen Yongxing?
Hainan General Hospital
Outcome results
None listed