Evaluation of Prognostic Impact of Serum Autoantibody in Patients with Metastatic Non-small-Cell Lung Cancer without EGFR activating mutation nor ALK fusion gene

Evaluation of Prognostic Impact of Serum Autoantibody in Patients with Metastatic Non-small-Cell Lung Cancer without EGFR activating mutation nor ALK fusion gene - Prognostic Impact of Serum Autoantibody in Metastatic Non-small-Cell Lung Cancer without activating mutations

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000016837

Enrollment

200

Registered

2015-03-20

Start date

2015-03-20

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: 1. Written informed consent 2. Patients aged >= 20 years 3. Pathologically-confirmed non-small-cell lung cancer 4. Stage IV disease (TNM classification, 7th edition) 5. Tumor without activating EGFR mutation (Del19 or L858R) nor ALK fusion gene 6. Standard platinum-containing chemotherapy with or without bevacizumab is scheduled as first-line chemotherapy 7. Performance Status of 0 or 1 (Eastern Cooperative Oncology Group) 8. Adequate organ function

Exclusion criteria

Exclusion criteria: 1. Concomitant other malignancy 2. Life expectancy <= 3 months 3. Use of steroid hormone, immunosuppressant, or biologic drug within 4 weeks at the time of enrollment 4. Severe active infection or poorly controlled disease ( e.g. hypertension, diabetes mellitus, cardiac disorder, gastro-intestinal bleeding, and so on) 5. Pregnant, possibly pregnant or lactating woman 6. Requiring radiation therapy to brain, mediastinum, or lung 7. Concomitant obvious interstitial lung disease on chest computed tomography 8. Poorly controlled malignant effusion requiring drainage 9. Otherwise determined by the investigator or the attending physician to be unsuitable as a subject in this study

Design outcomes

Primary

Measure	Time frame
The association between serum anti-RPL29 antibody levels and overall survival	—

Secondary

Measure	Time frame
1, The association between serum anti-RPL29 antibody levels and progression-free survival in first-line chemotherapy 2, The association of serum anti-CTLA-4 antibody levels with overall survival or progression-free survival in first-line chemotherapy 3, The association of serum anti-PD-1 antibody levels with overall survival or progression-free survival in first-line chemotherapy 4, The association of serum anti-BTLA antibody levels with overall survival or progression-free survival in first-line chemotherapy	—

Measure

Time frame

1, The association between serum anti-RPL29 antibody levels and progression-free survival in first-line chemotherapy 2, The association of serum anti-CTLA-4 antibody levels with overall survival or progression-free survival in first-line chemotherapy 3, The association of serum anti-PD-1 antibody levels with overall survival or progression-free survival in first-line chemotherapy 4, The association of serum anti-BTLA antibody levels with overall survival or progression-free survival in first-line chemotherapy

—

Countries

Japan

Contacts

Public ContactHiroshige Yoshioka

Kansai Medical University Hospital Dept. of Thoracic Oncology

hgyoshioka@gmail.com072-804-0101

Outcome results