A phase II study of Erlotinib and Bevacizumab combination therapy for previously treated III B / IV Stage non-squamous non-small cell lung cancer: IMSLC-001

A phase II study of Erlotinib and Bevacizumab combination therapy for previously treated III B / IV Stage non-squamous non-small cell lung cancer: IMSLC-001 - A phase II study of Erlotinib and Bevacizumab combination therapy for previously treated III B / IV Stage non-squamous non-small cell lung cancer: IMSLC-001

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011791

Enrollment

Registered

2013-09-18

Start date

2013-09-18

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-squamous non-small cell lung cancer

Interventions

Erlotinib 150mg/day Bevacizumab 15mg/kg q3w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)stage IIIB/IV or recurrence and histologically or cytologically confirmed non-squamous non-small cell lung cancer 2)history of 4 courses or more bevacizumab plus platinum doublet 3)known no active EGFR gene mutation or Unknown 4)20 years or older 5)PS:0-2 (ECOG) 6)at least one measurable leision (RECIST) 7)patients who has the following periods *the last prior chemotherapy:3weeks *whole-brain irradiation(WBRT):2weeks *stereotactic irradiation(SRI):1day *irradiation of bone metastases:1day *palliative radiotherapy:2weeks *operation(surgery without lobectomy):4weeks *operation(endoscopic surgery without lobectomy):2weeks *biopsy with incision, port custody, and treatment to injury:1week *pleurodesis:2weeks *chest drainage:1weeks 8)adequate bone marrow,liver,and renal functions *Neutrophil counts >= 1,500/mm3 *Platelets >= 100,000/mm3 *Hemoglobin concentration >= 9.0g/dL *AST and ALT, x 2.5 of upper limit of normal (ULN) or less *Total bilirubin <= 1.5mg/dL *Serum creatinin, x 1.5mg/dL of ULN or less *SpO2(Room air) >=90% * PT-INR < 1.5 *Protein urea <= 1+ 9)a life expectancy of 3 months or more 10)written informed consent

Exclusion criteria

Exclusion criteria: 1)Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.). 2)known EGFR-TKI resistance gene mutation positive 3)known ALK gene translocation positive 4)history of erlotinib or gefitinib treatment 5)inable of oral drug administration 6)current or previous histoty of hemoptysis(2.5ml)due to NSCLC 7)Risk of hemoptysis patients after thoracic radiation therapy is expected 8)With great vessel invasion 9)1cm or longer cavity in tumor 10)current or previous (within the last 1 year)history of GI perforation 11)history of myocardial infarction and cerebral infarction 12)planned surgery within study term 13)uncontrolled heypertension 14)symptomatic brain metastasis 15)history of drug allergy 16)massive,pleural effusion or ascites 17)uncontrolled infection or serious medical complications 18)active concomitant malignancy 19)mental disorder 20)pregnant or or lactating women or those who declined contraception 21)those judged not suitable by the attending physician

Design outcomes

Primary

Measure	Time frame
PFS at 3months after randomized	—

Secondary

Measure	Time frame
Response rate, Disease Control Rate, Progression-free survival, Overall survival, Safety, Biomarker	—

Countries

Japan

Contacts

Public ContactTadashi Takao

Itabashi Chuo Medical Center Department of Respiratory Medicine

respiratory_itabashichuo@yahoo.co.jp03-3967-0572

Outcome results

None listed

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