None listed
Conditions
Interventions
Drug : This clinical trial will be conducted in patients with advanced squamous epithelial lung cancer to evaluate the effectiveness and safety of standard immuno-chemotherapy and metformin combinatio
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed squamous epithelial cell lung cancer (mixed histology, for example, adenosquamous cell ca). (Excluding the back) 2. Progressive or recurrent AJCC-TNM 8th edition of stage IIIC or stage IV patients 3. Age 19 or older 4. Daily Performance Scale Based on Eastern Cooperative Oncology Group (ECOG) 0, 1, 2 5. Patients with at least one measurable or assessable lesion 6. Maximum fluorodeoxyglucose (FDG) standardized intake coefficient (SUL) greater than 9.0 in whole body or torso PET test 7. Results of PD-L1 expression test in tumor tissue 8. Serum creatinine = 1.8 mg/dL ( creatinine clearance> 45 ?/min), serum bilirubin = 2.0 mg/dL (if liver metastasis = 5x UNL), SGOT/SGPT = 2.5 x UNL (where liver metastasis is = 5x UNL), Serum Hemoglobin = 9.0 gm/dl, platelet count = 90,000/ul, total WBC count = 3,000/uL. 9. After hearing the explanation before the test, the test subject himself/herself or his/her agent voluntarily agrees in writing. 10. Agree with genetic testing and human-derived research
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received systemic chemotherapy for advanced lung cancer. However, if you receive adjuvant or neo-adjuvant therapy after surgery for the purpose of complete recovery and simultaneous radiation chemotherapy, it is allowed if more than 6 months have elapsed. 2. In the case of previous radiation therapy, it was not performed on the target lesion selected in this clinical trial unless the progress of the target lesion selected in the radiation port was confirmed, but is allowed if it was completed more than 3 weeks before the administration of the test drug. 3. If there is evidence of clinically active interstitial lung disease (a chronic stable patient with asymptomatic radiation changes is acceptable) 4. Invasive malignant tumors have occurred for more than three years before participating in the study, except for properly treated skin basal cell cancer or tumor and thyroid cancer in cervical epithelial cells 5. Evidence of severe or uncontrolled systemic or infectious diseases (e.g., cardiovascular, gastrointestinal, respiratory, endocrine, nervous, musculoskeletal, skin, and appendages) as determined by the researcher 6. A woman who is pregnant or breastfeeding. Women who are likely to become pregnant should use appropriate contraception. 7. Women or men of childbearing age who do not want to use effective contraception 8. Neurological abnormalities and brain metastasis and cerebrospinal metastasis that require steroid maintenance 9. If you have a history of taking metformin for the past 3 months 10. If you are taking a therapeutic dose of steroids and immunosuppressants for autoimmune diseases (a steroid dose of less than 10 mg of prednisolone for other purposes is allowed)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 month progression free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response rate;progression-free survival;overall Survival ; safety | — |
Countries
Korea, Republic of
Contacts
Public Contactjaeeun Yu
National Cancer Center
Outcome results
None listed