Randomized phase II study of chemoimmunotherapy with or withoutmetformin as a first-line treatment in patients with squamous cell lung carcinomahaving high 18F-fluorodeoxyglucose uptake

ational Cancer Center0 sites70 target enrollmentTBD

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional Study

Sex

All

Investigators

Sponsor

ational Cancer Center

Eligibility 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,

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)

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, Not Recruiting

N/A

Randomized fase II study using chemiotherapy with metformine in patients affected by pancreas metastatic cancer. - NDpancreas metastatic tumorMedDRA version: 9.1Level: HLTClassification code 10033632

EUCTR2010-020979-23-ITFONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR

Active, Not Recruiting

N/A

PHASE II TRIAL OF SEQUENTIAL CHEMO-IMMUNOTHERAPY WITH CAPECITABINE PLUS INTERFERON ALPHA2a FOLLOWED BY IL-2 IN PATIENTS WITH METASTATIC KIDNEY CANCER

EUCTR2004-002376-42-ITG.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST36

Active, Not Recruiting

N/A

Phase II multicenter study of immuno-chemotherapy with fludarabine, cyclophosphamide and rituximab (FCR) for symptomatic Waldenstrom's macroglobulinemia

EUCTR2005-000174-52-ITASSOCIAZIONE MALATTIE SANGUE

Active, Not Recruiting

N/A

Patients who suffer from T-Prolymphocytic leukemia and have received none or one chemotherapy so far will be treated with Fludarabine, Cyclophosphamide, Mitoxantrone and Alemtuzumab.ntreated patients with T-prolymphocytic leukemia (T-PLL) according to WHO criteria or pretreated patients (max. one previous treatment) with T-PLL .Therapeutic area: Diseases [C] - Cancer [C04]

EUCTR2008-001421-34-DEniversity of Cologne, Sponsor-Quality Management16

Active, Not Recruiting

N/A

Patients who suffer from T-Prolymphocytic leukemia and have received none or one chemotherapy so far will be treated with Fludarabine, Cyclophosphamide, Mitoxantrone and Alemtuzumab.ntreated patients with T-prolymphocytic leukemia (T-PLL) according to WHO criteria or pretreated patients (max. one previous treatment) with T-PLL.Therapeutic area: Diseases [C] - Cancer [C04]

EUCTR2008-001421-34-ATniversität zu Köln16