NSCLC
Conditions
Interventions
Low dose group:Cordycepin 1 capsule orally twice a day
take cordycepin starting one week before treatment, orally, twice daily, in the morning and evening, half an hour after meals with water. Continue taking orally for a total of three months.
Camrelizum
Medium dose group:Cordycepin 2 capsules orally bid
Cordycepin is taken one week before treatment, orally twice a day, in the morning and evening, half an hour after meals with water. Continue taking orally for a full three months.
Camrelizumab: Camrel
High-dose group:Cordycepin 3 capsules orally twice a day
Sponsors
Changzhou No.2 People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Willing to participate in the trial and sign a written informed consent form; 2. Male or female, aged 18 years or older and 75 years or younger (including 18 and 75); 3. Expected survival time >= 3 months and able to be followed up; 4. Histologically/cytologically and radiologically confirmed stage IIIB/IV NSCLC, with at least one measurable lesion according to RECIST 1.1 criteria; 5. Disease progression confirmed by the investigator according to RECIST 1.1 criteria based on at least two pretrial radiological examinations of diagnostic quality, following at least two cycles of platinum-based doublet chemotherapy. ECOG performance status of 0 or 1 within 7 days prior to randomization; 6. Hematology and organ function requirements: Within 14 days prior to treatment initiation, complete blood count, liver, kidney, and hormone function tests must meet the following standards: WBC >= 3.5 × 10^9/L, PLT >= 100 × 10^9/L, ANC >= 1.5 × 10^9/L, HGB >= 90 g/L, AST < 2.5 × ULN (or < 5 × ULN for patients with liver metastasis), ALT < 2.5 × ULN (or < 5 × ULN for patients with liver metastasis), total bilirubin < 1.5 × ULN, serum creatinine < 1.25 × ULN; cortisol within the normal range; thyroid function within the normal range. If the subject is on anticoagulant therapy, corresponding hematologic parameters must remain within the required treatment range; 7. Female subjects must use effective contraception throughout the study; serum or urine pregnancy tests at screening and throughout the study must be negative; 8. Male subjects must use effective contraception during treatment and for 6 months after completion of treatment.
Exclusion criteria
Exclusion criteria: 1. Subjects who have received prior chemotherapy, radiotherapy, or biological cancer therapy without completing the required washout period (i.e., 5 half-lives) before the first dose of study treatment; 2. Subjects who, within four weeks prior to the first dose of study treatment, received cancer therapy drugs and have not recovered to CTCAE grade I or are still experiencing drug-related adverse reactions; 3. Subjects who have taken erlotinib, gefitinib, afatinib, or crizotinib within one week prior to the first dose of study treatment, or who took any of these agents more than one week earlier but have not recovered from adverse events to CTCAE grade I or better; 4. Subjects requiring other forms of antitumor therapy during the study (including maintenance therapies for non-small cell lung cancer with other agents); 5. Subjects with a history of prior treatment with anti–PD-L1 monoclonal antibody or anti–CTLA-4 monoclonal antibody. Subjects previously treated with anti–PD-L1 antibody may be eligible if the washout period is at least four weeks; 6. Subjects with risk factors for bowel obstruction or gastrointestinal perforation (e.g., but not limited to, acute diverticulitis, intra-abdominal abscess, or abdominal carcinomatosis); 7. Subjects with a history of hematologic malignancies, malignant primary brain tumors, malignant sarcomas, or other malignant primary solid tumors, unless they have been disease-free for at least five years; 8. Subjects with chronic conditions requiring systemic corticosteroid therapy or any other form of immunosuppressive therapy. Subjects receiving physiologic replacement doses of hydrocortisone or equivalent will be considered eligible for this study (e.g., 20 mg hydrocortisone [or 5 mg prednisone] in the morning and 10 mg hydrocortisone [or 2.5 mg prednisone] in the evening).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Endpoints;Overall survival;Objective response rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactDawei Zhu
Changzhou No.2 People’s Hospital
Outcome results
None listed