A phase II study of erlotinib plus bevacizumab in chemo-naive patients aged 75 or older with advanced non-squamous non-small-cell lung cancer harboring sensitive EGFR gene mutations(HSR1501)

A phase II study of erlotinib plus bevacizumab in chemo-naive patients aged 75 or older with advanced non-squamous non-small-cell lung cancer harboring sensitive EGFR gene mutations(HSR1501) - A phase II study of AT for advanced Non-Sq NSCLC in elderly patients(HSR1501)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016904

Enrollment

Registered

2015-03-24

Start date

2015-03-01

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

Advanced non-squamous non-small-cell lung cancer

Interventions

Patients receive erlotinib plus bevacizumab every three weeks, as long as patients do not apply to treatment discontinuation criteria, until the disease progresses.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All participants must meet the following criteria 1: Pathologically proven Non-Sq NSCLC 2: Radiographically measurable lesion 3: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 4: Stage 3B/4 NSCLC or recurrence disease without prior chemotherapy 5: Age more than 75 years 6: adequate organ function Neutrophil count: more than 1,500/uL Platelet count: more than 100,000/uL Hemoglobin: more than 9.0 g/dL Aspartate transaminase (AST), alanine transaminase(ALT): 2.5 times the upper limit of normal of the institutional reference range Total bilirubin: less than 1.5mg/dL. PaO2: more than 60 torr Serum creatinine: less than 1.5mg/dL 7: Life expectancy of more than 12 weeks 8: Written informed consent 9:Sensitive EGFR mutation (exon19 deletion or exon21 L858R) confirmed by PCR

Exclusion criteria

Exclusion criteria: Exclusion criteria are as follows 1: Squamous cell carcinoma 2: Active interstitial pneumonia identified by chest X-ray 3: Current or previous histoty of hemoptysis (2.5ml) due to NSCLC 4: Uncontrolled massive pleural effusion or cardiac effusion 5: Superior vena cava syndrome 6: Uncontrolled brain metastases 7: Uncontrolled diabetes mellitus, hypertension, hepatic disorder, angina pectoris or previous myocardial infarction within the last 3 months 8: Severe infection 9: Pregnancy or lactation 10: Active concomitant malignancy 11: History of severe allergic reactions to drugs 12: Evidence of bleeding diathesis or hemoptysis 13: Current or previous history of cerebrovascular disease 14: Current or previous history of GI perforation 15: A history of chest irradaiation. 16: Exon T790M mutation detected by PCR 17: Severe and unstable medical comorbidities 18: Being unsuitable for receiving the study treatment, judged by attending physicians

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
Response rate, overall survival, safety	—

Countries

Japan

Contacts

Public ContactSeiichiro Suzuki

Hamamatsu Univ. School of Medicine Department of Internal medicine, second division

sesuzuki@hama-med.ac.jp053-435-2111

Outcome results

None listed

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