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

Prospective study of anti-PD-1 antibody therapy in advanced non-small cell lung cancer patients who previously treated with anti-PD-L1 antibody - JRC-IO-B

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000033657

Enrollment

Registered

2018-08-07

Start date

2018-08-01

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

lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Non-small cell lung cancer patient confirmed by cytology or histology. 2. Patients who are refractory to or recurrence of anti-PD-L1 antibody therapy after the second-line treatment (in the case of post-surgical chemotherapy with anti-PD-L1 treatment, postoperative chemotherapy is treated as primary treatment). The history of use of cytotoxic agents and molecular targeted therapeutic agents is not limited. The expression rate of PD-L1 does not matter. 3. Age 20 years and over. 4. PS (ECOG): 0-2. 5. Patient with measurable lesion (RECIST 1.1). 6. There are no major obstacles to the main organs (bone marrow, heart, lung, liver, kidney etc.). 7. Surgery for primary lesion Patients who have had more than 14 days of radiation therapy after radical irradiation of recurrent patients or primary lesions after resection. 8. Pre-immune checkpoint inhibitor Patients who are more than 14 days old since the last administration. 9. Patient who gained consent from the patient to the treatment.

Exclusion criteria

Exclusion criteria: 1. Patient whose administration of immune checkpoint inhibitor is contraindicated. 2. Patient with a history of cardiac function abnormality (acknowledging abnormality requiring treatment by electrocardiogram) or a history of myocardial infarction within 6 months before registration Patient with uncontrolled angina pectoris or heart failure. Patients with active duplicated cancers (excluding carcinoma within the carcinoma and duplicate carcinoma with no recurrence for more than 5 years). 3. Cases with complications of infection or patients suspected of having infection with fever 38 degrees Celsius or higher. 4. Pregnant women, patients who may be pregnant, breastfeeding patients. 5. Other patients judged inappropriate by the attending physician due to serious complications.

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Progression free survival: PFS Overall survival: OS Disease control rate: DCR Safety Predictors	—

Countries

Japan

Contacts

Public ContactTakehiro Izumo

Japanese Red Cross Medical Center Respiratory Medicine

drtake111@gmail.com03-3400-1311

Outcome results