Prospective pilot study of anti-PD-L1 antibody therapy in advanced non-small cell lung cancer patients who previously responded to anti-PD-1 antibody

Not Applicable

• Conditions: advanced non-small cell lung cancer

• Registration Number: JPRN-UMIN000031888
• Lead Sponsor: Saitama medical university International medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-01
• Study Completion: 2020-03-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients with a history of complication of autoimmune disease or chronic or recurrent autoimmune disease. * However, patients whose condition is controlled by replacement therapy such as chronic thyroiditis and type I diabetes are not excluded. 2. Patients with active or symptomatic interstitial pneumonia. 3. Patients with infectious diseases requiring systemic treatment. 4. Patients who are merging psychosis or psychiatric symptoms and are considered difficult to participate in the study. 5. Patients with symptomatic brain metastases. * However, clinically stable brain metastasis cases can be registered. 6. Patients complicated of poor control diabetes. 7. Patients with severe complications (heart of poor control, lungs, liver, kidney disease etc.) 8. Patients with active liver disease (HBV DNA positive, alcoholic hepatitis, autoimmune hepatitis, liver cirrhosis etc.) * If HBs antigen positive, HBs antibody positive, HBc antibody positive, measure HBV DNA. Exclude cases where HBV DNA is positive. 9. Patients who are undergoing systemic administration of steroid for at least 4 weeks at the time of registration. * However, steroids within 10 mg / day in terms of prednisolone are acceptable. 10. Male without intention to contraception. Or pregnant women, lactating women, women who are positive for pregnancy tests or women who are not willing to contraception. 11. Patients with a history of severe hypersensitivity. 12.Patients who are judged by the investigator or shared medical doctor to be inappropriate for participating in this study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival