Prospective study of evaluation to the predictive biomarker of Nivolumab by tumor tissue specimen and neighboring bronchoaveolar lavage fluid (BALF) and Blood

Prospective study of evaluation to the predictive biomarker of Nivolumab by tumor tissue specimen and neighboring bronchoaveolar lavage fluid (BALF) and Blood - Evaluation to the predictive biomarker of Nivolumab by Tumor tissue, BALF, and Blood

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023822

Enrollment

Registered

2016-08-30

Start date

2016-09-01

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

previously treated patients with advanced non-small-cell lung cancer

Interventions

Performe tumor biopsy, BAL, and blood collection before the Nivolumab treatment. Performe tumor biopsy, BAL, and blood collection at disease progression and appearing new lesion in the lung during Ni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Histologically or Cytologically documented non-small-cell lung cancer (2)Stage VI or recurrent diseases without any indications for operation and radiotherapy (3)Have measuarable lesion in lung by using the RECIST ver1.1 (Response Evaluation Criteria In Solid Tumors) criteria and can performe tumor biopsy by bronchoscopy (4)Must be 20 or more years old at tne time of consent (5)Have Eastern Coopperative Oncology Group Perfoemance Status (ECOG PS) 0-1 (6)Have adequate organ function within two weeks before study entry. (7)Estimate life expectancy of at least 12 weeks (8)Have signed an informed consent document

Exclusion criteria

Exclusion criteria: (1)With interstitial pneumonia or pulmonary fibrosis on a chest X-ray (2)Clinically significant drug allergy (3)Presencee of other active malignancy (4)With pericardial effusion, pleural effusion and ascites in need of treatment of drainage (5)Positive serum HBs antigen (6)With severe infection, cardiac diseases, diabates, hypertention, other severe complication (7)Patients received palliative radiotherapy for brain metastases and bone metastases, except for the primary lesion within 2weeks. (8)Pregnancy or lactating patients (9)The case that be judged as the inappropriate object of the this examination

Design outcomes

Primary

Measure	Time frame
We will reveal predictive biomarker for nivolmab by evaluate the tumor tissue, BALF, and blood collection.	—

Secondary

Measure	Time frame
Progression free Survival, Overall Survival, Response Rate, Disease Control Rate, safety	—

Countries

Japan

Contacts

Public ContactMotohiro Tamiya

Osaka Medical Center for Cancer and Cardiovascular Diseases Thoracic Oncology

moto19781205@yahoo.co.jp+81-(0)6-6972-1181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026