Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Conditions
Interventions
Intervention group:Toripalimab combined with Clostridium Butyricum and Chemotherapy with or without Bevacizumab
Sponsors
Peking University Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
18 Years to 69 Years
Inclusion criteria
Inclusion criteria: 1. Sign informed consent form (ICF); 2. Histologically and/or cytologically confirmed advanced or recurrent non-squamous non-small cell lung cancer with sensitive EGFR mutations that meet the following conditions: (1) There was no EGFR20 exon T790M mutation after treatment failure of previous first or second generation EGFR-TKI (including gefitinib, erlotinib, ectinib and Afatinib); (2) Tissue or blood EGFR20 exon T790M mutation after treatment failure of first-generation or second-generation EGFR-TKI (including gefitinib, erotinib, Ectinib and Afatinib), and subsequent treatment failure of third-generation EGFR-TKI (oechitinib or other domestic third-generation drugs); (3) Previous first-line treatment with third-generation single EGFR-TKI (ohitinib or other domestic third-generation drugs) failed; Had not received palliative systemic chemotherapy, had been allowed to receive neoadjuvant/adjuvant chemotherapy before, and had disease recurrence or metastasis more than 6 months after the completion of the last dose of chemotherapy; 3. Have at least one measurable lesion (according to RECIST 1.1); Note: Lesions that have previously received radiotherapy cannot be considered as target lesions unless there is definite progression after radiotherapy; 4. Prepare to receive pemetrexed, carboplatin ± bevacizumab treatment regimen; 5. Aged range from 18 to 69 years, gender is not limited; 6. ECOG score 0-1; Expected survival >=3 months; 7. Laboratory results during the screening period must meet the following requirements: (1) Blood routine: neutrophil absolute number (ANC) >=1.5x10^9/L, platelet count (PLT) >=100x10^9/L, hemoglobin (HGB) >=90g/L; (2) Liver function: total bilirubin (TBIL) =60ml/min (Cockcroft-Gault formula), urine protein <2+ or 24h urine protein quantity <1g; (4) International standardized ratio (INR) <=1.5 ULN, partial prothrombin time (PTT) or activated partial thrombin time (APTT) <=1.5 ULN during the 7 days prior to treatment; 8. Within 21 days prior to enrollment, women of reproductive age must confirm that the serum pregnancy test is negative and consent to use effective contraception during the study drug use period and within 60 days after the last dose. In this scheme, women of reproductive age are defined as sexually mature women: (1) No hysterectomy or bilateral oophorectomy; (2) Natural menstrual cessation that has not been continuous for 12 months (amenorrhea after cancer treatment does not preclude fertility) (i.e., menstruation at any time during the previous consecutive 12 months).
Exclusion criteria
Exclusion criteria: 1. The tumor was confirmed by histology or cytology to be complicated with small-cell lung cancer or squamous cell carcinoma; 2. Symptomatic central nervous system metastases; Patients with asymptomatic BMS or symptoms stable for >=2 weeks after treatment of BMS, and patients who have stopped systemic sex hormone therapy (dose >10mg/ day of prednisone or other therapeutic hormones) for more than 2 weeks can be included; 3. The patient has any active autoimmune disease or a history of autoimmune disease; 4. Previous use of anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-ctLA-4 antibodies (or any other antibodies that act on T-cell costimulation or checkpoint pathways); 5. Received any anti-infective vaccine (such as influenza vaccine, chickenpox vaccine, etc.) within 4 weeks before enrollment; 6. Large to medium surgeries or unhealed surgical incisions, ulcers or fractures within 4 weeks prior to initial medication; 7. Receiving any other form of immunosuppressive therapy within 7 days prior to initial administration, excluding nasal spray, inhalation or other routes of topical corticosteroids or physiological doses of systemic corticosteroids (<=10mg/ day of prednisone or equal doses of drugs); 8. Treated uncontrolled hypertension (systolic blood pressure greater than 150mmHg and/or diastolic blood pressure greater than 90mmHg), a history of hypertensive crisis or hypertensive encephalopathy; 9. Active, untreated hepatitis B; 10. Lactating patients; A patient who is fertile but does not want to take contraceptive measures or his sexual partner does not want to take contraceptive measures; 11. Patients who have previously received allostem cell or parenchymal organ transplantation; 12. Any other disease or condition of clinical significance that the investigator believes may affect protocol compliance, or may affect the patient's signing of the informed consent (ICF), or may be ineligible to participate in the clinical trial; 13. Patients with a history of allergy to microecologics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Duration of response (DoR);Disease control rate (DCR);Time to response (TTR);Overall survival (OS);6-month progression-free survival rate;1-year overall survival rate;Treatment-related adverse events; | — |
Countries
China
Contacts
Public ContactZhao Jun
Peking University Cancer Hospital & Institute
Outcome results
None listed