Prospective Observational Study of Nutritional/Immunologic Indices as Predictive Biomarkers to Anti-PD-1 Drugs in Non-small-Cell Lung Cancer

Prospective Observational Study of Nutritional/Immunologic Indices as Predictive Biomarkers to Anti-PD-1 Drugs in Non-small-Cell Lung Cancer - ICI-PREDICT study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000040450

Enrollment

300

Registered

2020-05-21

Start date

2019-12-20

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: ?Pathologically confirmed non-small cell lung cancer (cytology or histology) ?Available programmed cell death-ligand 1 expression on tumor cells (tumor proportion score) ?Any target lesions designated by Response Evaluation Criteria in Solid Tumors version 1.1 ?Minimum age of 20 years old ?Stage IV disease or Stage III disease not applicable for definitive chemoradiotherapy ?Treatment with checkpoint inhibitors (monotherapy or combined with chemotherapy) as 1st line therapy ?Written informed consent from the patient

Exclusion criteria

Exclusion criteria: ?Any oncogene mutation (epidermal growth receptor factor, anaplastic lymphoma kinase, c-ros oncogene 1, RET, BRAF) ?Difficulty in evaluating pre-treatment nutritional/immunologic ?Active other kind of cancer ?Active infection with HIV, hepatitis B, or hepatitis C virus ?History of cancer immunotherapy ?Considered to be unsuitable for enrolment by the investigator's judgment

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Overall survival Response rate Disease control rate Cancer-specific progression-free survival Cancer-specific overall survival Safety	—

Countries

Japan

Contacts

Public ContactTakamori Shinkichi

National Hospital Organization Kyushu Cancer Center Thoracic Oncology

shinkichi.takamori@gmail.com092-541-3231

Outcome results