Prospective multicenter observation study of anti-PD-1/PD-L1 antibody re-treatment who previously treated with anti-PD-1/PD-L1 antibody plus chemotherapy

Prospective multicenter observation study of anti-PD-1/PD-L1 antibody re-treatment who previously treated with anti-PD-1/PD-L1 antibody plus chemotherapy - NJLCG1901 Prospective multicenter observation study of anti-PD-1/PD-L1 antibody re-treatment who previously treated with anti-PD-1/PD-L1 antibody plus chemotherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000038413

Enrollment

Registered

2019-11-01

Start date

2019-10-27

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

Non-small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed non-small cell lung cancer 2) Unresectable, locally advanced or metastatic non-small cell lung cancer 3) Patients with driver mutation/translocation negative or unknown 4) Patients who have worsened after the use of anti-PD-1/PD-L1 antibody plus chemotherapy for first-line treatment 5) Patients who are scheduled to start anti-PD-1/PD-L1 antibody re-treatment 6) At least one measurable lesion according to RECIST ver1.1 (within 28 days before enrollment) 7) Patients not younger than 20 years old at the time of informed consent 8) Life expectancy of at least 3 months 9) Patients providing written informed consent

Exclusion criteria

Exclusion criteria: 1) Active double cancer 2) Patients with a history of severe immune-related adverse events associated with anti-PD-1/PD-L1 antibody 3) Patients with active autoimmune disease 4) Patients with infectious disease requiring systemic treatment 5) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis 6) Patients with significant complications 7) Patiens who are undergoing systemic administration of steroid greater than 10mg daily of prednisone 8) History or severe drug allergies 9) Pregnant females, possibly pregnant females, females wishing to become pregnant, females of breastfeeding and males wishing to their partner's pregnant 10) Physician concludes that the patient's participation is inappropriate

Design outcomes

Primary

Measure	Time frame
Overall Response Rate	—

Countries

Japan

Contacts

Public ContactYosuke Kawashima

Sendai Kousei Hospital Department of pulmonary medicine

yousukekawashima3@yahoo.co.jp022-222-6181

Outcome results