First-line Replacement Maintenance of Envafolimab in Advanced NSCLC

Exclusion Criteria

• •1. Patients with known EGFR sensitive mutations or ALK rearrangements;
• •2. Patients who have received first-line standard treatment and progressed in the past;
• •3. Subjects with active central nervous system (CNS) metastasis, if the subject's CNS metastasis can be adequately treated, and the subject's neurological symptoms can return to baseline levels at least 2 weeks before enrollment treatment-related residual signs or symptoms), can participate in the study. In addition, the subject must also be a corticosteroid-free subject or receive a stable or tapering dose of ≤10 mg/day of prednisone (or equivalent);
• •4. Received systemic systemic treatment of Chinese patent medicines with anti-lung cancer indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for controlling pleural effusion) within 2 weeks before the first administration;
• •5. Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose;
• •6. Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) has occurred within 2 years before the first dose. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy;
• •7. Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: Physiological doses of glucocorticoids (≤10 mg/day prednisone or equivalent) are allowed;
• •8. Those who are known to be allergic to the active ingredients or excipients of the study drugs such as envolimab and pemetrexed;
• •9. Pregnant or lactating women;
• •10. Has not sufficiently recovered from toxicity and/or complications from any intervention (ie, ≤ Grade 1 or reached baseline, excluding fatigue or alopecia) prior to initiating treatment;
• •11. Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive);
• •12. Untreated active hepatitis B (defined as HBsAg positive and the detection of HBV-DNA copy number greater than the upper limit of the normal value of the laboratory department of the research center);
• •Note: Hepatitis B subjects who meet the following criteria can also be enrolled:
• •1. HBV viral load \<1000 copies/ml (200 IU/ml) before the first dose, subjects should receive anti-HBV therapy throughout the study treatment period to avoid viral reactivation;
• •2. For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV treatment is not required, but viral reactivation needs to be closely monitored; 13. Active HCV infected subjects (HCV antibody positive and HCV-RNA level higher than the detection limit); 14. Received live vaccine within 30 days before the first dose (cycle 1, day 1); Note: Injected inactivated virus vaccine against seasonal influenza within 30 days prior to the first dose is permitted; however, intranasal live attenuated influenza vaccine is not permitted.
• •15\. Presence of any serious or uncontrolled systemic disease such as:
• •1. There are significant abnormalities in the rhythm, conduction or morphology of the resting ECG, and the symptoms are severe and difficult to control, such as complete left bundle branch block, second-degree heart block, ventricular arrhythmia or atrial fibrillation;
• •2. Unstable angina pectoris, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) classification ≥ grade 2;
• •3. Myocardial infarction occurred within 6 months before enrollment;
• •4. Unsatisfactory blood pressure control (systolic blood pressure\>140 mmHg, diastolic blood pressure\>90 mmHg);
• •5. There is a history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or there is currently clinically active interstitial lung disease;
• •6. Active pulmonary tuberculosis;
• •7. There is an active or uncontrolled infection that requires systemic treatment;
• •8. Clinically active diverticulitis, abdominal abscess, and gastrointestinal obstruction;
• •9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
• •10. Poor control of diabetes (fasting blood glucose (FBG) \> 10mmol/L);
• •11. Urine routine indicates urine protein ≥++, and 24-hour urine protein quantification \>1.0 g;
• •12. Patients with mental disorders and unable to cooperate with treatment; 16. Medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the results of the trial, prevent the subjects from participating in the research throughout the study, or the investigator considers other circumstances that are not suitable for inclusion or have other potential risks and are not suitable to participate in this research. .