Lung Neoplasm
Conditions
Interventions
Experimental group:Immune checkpoint inhibitor combined with metformin hydrochloride extended release tablets at maintenance phase
Control group:Immune checkpoint inhibitor combined with placebo at maintenance phase
Sponsors
Yunnan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female, above 18 years old (including). 2. The patient's ECOG score should be 0-2. 3. The expected survival time is greater than 12 weeks. 4. According to 8th edition of Lung Cancer TNM Staging System of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer, this study includes patients with locally advanced (stage IIIB/IIIC) or metastatic or recurrent (stage IV) squamous non-small cell lung cancer that has been confirmed by histology and for whom surgery is not feasible and who cannot undergo radical concurrent chemoradiotherapy. (Note: Mixed tumors will be classified according to the predominant cell type. If there is a small cell component, the study participants do not meet the inclusion criteria.) 5. After a histological or cytological diagnosis of advanced (IIIB-IV stage) squamous non-small cell lung cancer, the patients received 6 cycles of first-line immunotherapy combined with platinum-based double-drug chemotherapy. And the study participants were evaluated as stable disease (SD), partial response (PR), or complete response (CR) by radiological examination (according to the RECIST 1.1 standard) after the last cycle of chemotherapy. (The immune checkpoint inhibitors used were those recommended by the NCCN, ESMO, and CSCO guidelines for advanced squamous non-small cell lung cancer, including but not limited with: sintilimab, tislelizumab, atezolizumab, serplulimab, camrelizumab, etc.) 6. For those who have received adjuvant chemotherapy before, the interval between the recurrence of the disease and the last adjuvant chemotherapy should be at least 6 months; and the interval between the end of the previous thoracic radiotherapy and this treatment should be more than 6 months. 7. There is at least one evaluable lesion (non-intracranial lesion) under RECIST1.1 criteria 8. Able to swallow pills 9. blood routine examination: Absolute neutrophil count (ANC) >= 1.5×10^9/L or White blood cell count >3.5×10^9/L, platelet (PLT) >= 80×10^9/L, hemoglobin (HGB) >= 90 g/L. 10. Liver function: serum total bilirubin (TBIL) = 2.8g/dL. 11. Kidney function: serum creatinine (Cr) = 40 mL/min (standard Cockcroft Gault formula) For females: CrCl=[(140-age) × weight (kg) × 0.85]/[72 × serum creatinine (mg/dL)] For males: CrCl=[(140-age) × weight (kg) ×1.00]/[72 × serum creatinine (mg/dL)] 12. The study participants and his/her couple are required to use at least one medical approved contraceptive measures (e.g. intrauterine device, contraceptive pill or condom) during the study treatment period and 6 months after the end of study treatment. 13. Before the treatment and sampling (peripheral blood and Defecate) analysis related to this study, The study participants can fully understand and cooperate, then an informed consent should be signed.
Exclusion criteria
Exclusion criteria: 1. Histological or cytological pathology confirms the presence of small cell components, or the main component is non-squamous carcinoma. 2. Symptomatic central nervous system metastasis or meningeal metastasis, or metastasis that cannot be controlled, i.e., confirmed by examination within 2 months after radiotherapy or other local treatment, or judged by the investigator to be unsuitable for inclusion. 3. Patients with type 1 or type 2 diabetes. 4. Newly diagnosed or unrelieved spinal cord compression after treatment, or has been diagnosed before but no clinical evidence of disease stabilization >= 1 week before treatment. 5. Third space effusion with clinical symptoms needs repeated drainage (e.g., less than once every 4 weeks), such as pericardial effusion, pleural effusion, and peritoneal effusion that cannot be controlled by suction or other treatments. 6. Other malignant tumors diagnosed <= 5 years before the first dose, except for adequately treated carcinoma in situ of cervix, basal cell or squamous cell skin cancer, local prostate cancer after radical mastectomy, and ductal carcinoma in situ after radical mastectomy ( Endocrine therapy for non-metastatic prostate or breast cancer is allowed). 7. Active, known or suspected autoimmune diseases (autoimmune diseases that may exist before enrollment), including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease etc. (1) Residual hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy, or no replase expected in the absence of external stimulus are allowed (2) Patients with eczema, psoriasis, lichen simplex chronicus or only skin disease manifestations of vitiligo (psoriatic head arthritis needs to be excluded) if the rash covers area less than 10% of the body surface area, the disease has been adequately controlled at baseline and requires only low potency topical steroids with no acute exacerbations of underlying disease within past 12 months (no psoralen plus ultraviolet radiation [PUVA], methotrexate, retinoids, biologics, oral calcineurin inhibitors, high potency oral steroids) can enter the study. 8. Patients with a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as obstructive bronchiolitis), drug-induced pneumonia, radiation-related pneumonitis requiring steroid therapy, or active pneumonia with clinical symptoms, or other moderate to severe lung disease seriously affect pulmonary function (patients with a history of radiation pneumonitis (fibrosis) limited in the radiation area can participate in this study). 8. HBsAb positive and HIV DNA copy number greater than 1000 copy number/ml or 200 IU/ml, or HCV positive (HCV RNA or HCV Ab detection indicates acute and chronic infection) or known HIV positive medical history or known Acquired Immunodeficiency Syndrome (Acquired Immunodeficiency Syndrome, AIDs), HCV positive (HCV RNA or HCV Ab detection indicates acute and chronic infection) can be enrolled after control. 9. Patients with a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as obstructive bronchiolitis), drug-induced pneumonia, radiation-related pneumonitis requiring steroid therapy, or active pneumonia with clinical symptoms, or other moderate to severe lung disease seriously affect pulmonary function (patients with a history of radiation pneumonitis (fibrosis) limited in the radiation area can participate in t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival time;safety; | — |
Countries
China
Contacts
Public ContactRunxiang Yang
Yunnan Cancer Hospital
Outcome results
None listed