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

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 - 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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000031888

Enrollment

Registered

2018-04-01

Start date

2018-06-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced non-small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: More than 3 months have passed from anti-PD-1 antibody therapy termination (including patients using primary therapeutic pembrolizumab) in patients with advanced stage non-small cell lung cancer. Patients with the most excellent effect of anti-PD-1 antibody are CR, PR, SD (patients with SD or higher effect). Basic organ function is maintained Prognosis of more than 3 months is expected at registration

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Countries

Japan

Contacts

Public ContactTakahiro Uchida

Saitama medical university International medical Center Department of Respiratory medicine

uchitaka@saitama-med.ac.jp0429-84-4111

Outcome results