Lung Cancer
Conditions
Interventions
Experimental group:NAD+supplements: start taking on the day of enrollment, NMN12000 GeneHarbor:150mg, Oral administration, 1-3 times a day.
Sponsors
Division of Thoracic Tumor Multimodality Treatment, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Metastatic (stage IV) non-small cell lung cancer with histologically or cytologically confirmed inoperative treatment and inability to receive radical concurrent chemoradiotherapy, and at least first-line therapy, according to the TNM stage of lung cancer of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification 8th Edition; 2. At least 2 measurable target lesions (RECIST v1.1 criteria), intracranial lesions that are not included as radiotherapy lesions or observational lesions due to immune exemption, liver lesions that are not included as observational lesions due to immune exemption, and bone lesions that are not included as observational lesions because they are not measurable. For a lesion that has received prior radiotherapy, it can only be considered a target lesion if there is clear disease progression after radiotherapy. Patient who intends to receive radiotherapy in combination with PD-1 inhibitors, or who is receiving PD-1 inhibitor therapy and has undergone or intends to receive radiotherapy within 1 month from the date of enrollment; 3. Agree to provide tumor tissue specimens, which can be previously archived or freshly obtained, for the detection of biomarkers; 4. Voluntarily signed written informed consent. Informed consent must be signed prior to any protocol-related procedures that are not part of the subject's routine medical care. Subjects signed the informed consent form and signed it. Subjects must be willing and able to comply with the visits, treatment protocols, laboratory tests, and other requirements of the study as specified in the schedule. Age >=18 years and =3 months; 6. Provide reports confirming that EGFR, ALK, and ROS1 are wild-type through tissue-based testing. For patients with non-squamous NSCLC who do not have proven wild-type EGFR and wild-type ALK, tumor samples (archival or fresh, primary or metastatic) need to be collected prior to enrollment for evaluation of EGFR and ALK tests (at a local laboratory or central laboratory). If tumor tissue is not documented, a fresh tumor biopsy sample must be taken at baseline; 7. Subjects with good organ function indicated by the results of laboratory examinations during the screening period (no use of any blood components and cell growth factor supportive therapy is allowed within 2 weeks prior to randomization): Hematology: absolute neutrophil NEC >=1.5×10^9 /L; Platelet count > = 100×10^9/L; Hemoglobin > = 9.0 g/dL. Renal: Creatinine clearance (CrCl) calculated >=50 mL/min, CrCl will be calculated using the Cockcroft-Gault formula (Cockcroft DW, 1976) CrCL (mL/min) = [(140 - age)× body weight (kg)×F]/(SCr(mg/dL)×72), where F=1 for women and F = 0.85 for men; SCr=serum creatinine. Liver: serum total bilirubin (TBil) <=1.5×ULN; For subjects with liver metastases or evidence confirmed/suspected Gilbert's disease, TBil <=3×ULN ii. AST and ALT <=2.5×ULN; For subjects with liver metastases, AST and ALT<=5×ULN d Coagulation Function: International Normalized Ratio and Activated Partial Thromboplastin Time <=1.5×ULN (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT, INR, and APTT) are within the expected range for treatment with anticoagulants at screening).
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating females. 2. Any condition that, in the opinion of the investigator, may result in the risk of receiving study treatment, or that would interfere with the evaluation of the study treatment or the interpretation of the subject's safety or study results. 3. Prior treatment with EGFR antagonists or ALK antagonists. 4. Prior participation in the study of an investigational drug or receipt of study treatment or use of an investigational device within 4 weeks prior to the first dose. 5. Concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study (defined as the time of first dose more than 4 weeks from the last dose of the previous clinical study or more than 5 half-lives of the investigational drug). 6. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 7. Has an active, known or suspected autoimmune disease, or has a history of autoimmune disease, with the following exceptions: vitiligo, alopecia, Grave's disease, psoriasis, or eczema that has not required systemic treatment in the past 2 years, hypothyroidism (caused by autoimmune thyroiditis) requiring only a stable dose of hormone replacement therapy and type I diabetes mellitus requiring only a stable dose of insulin replacement therapy, or subjects whose childhood asthma has been in complete remission and does not require any intervention after adulthood, or the disease does not recur in the absence of external triggers. 8. Active or previously documented inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea). 9. Subjects requiring systemic treatment with corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose. Exceptions are made to the following: a) If there is no active autoimmune disease, treatment with inhaled, ophthalmic or topical steroids and adrenocorticosteroids at doses not exceeding 10mg/day efficacy dose of prednisone is permitted. b) Physiologic doses of systemic glucocorticoids not exceeding 10 mg/day of prednisone or equivalent doses of other glucocorticoids. c) Glucocorticoids as a prophylaxis for hypersensitivity reactions (e.g., before CT). 10. Known history of primary immunodeficiency virus infection. 11. Other active malignancy within 5 years prior to enrollment. Locally curable cancers (which appear to be cured) are excluded, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ. 12. Major surgical procedure (as defined by the investigator, such as open biopsy, severe trauma, etc.) within 28 days prior to the first dose. NOTE: For replacement intravenous infusion droppers are acceptable. Those who have a major surgical procedure planned within 30 days (as determined by the investigator) of the first dose, or who have not fully recovered from previous surgery. Local procedures (such as placement of systemic ports, core needle biopsy, and prostate biopsy) are permitted, provided that the procedure is completed at least 24h prior to the time of the first dose of study treatment. 13. Subjects who have failed to recover from toxicity and/or complications of the previous intervention to NCI-CTC AE<=1 grade (except alopecia and fatigue) prior to the first dose. 14. History of gastrointestinal perforation and/or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactXuanwei Zhang
West China Hospital of Sichuan University
Outcome results
None listed