Phase II Trial of Erlotinib Plus Bevacizumab for Patients with Advanced Non-Small-Cell Lung Cancer Who harboring EGFR mutation.

Phase II Trial of Erlotinib Plus Bevacizumab for Patients with Advanced Non-Small-Cell Lung Cancer Who harboring EGFR mutation. - Phase II Trial of Erlotinib Plus Bevacizumab for Patients with Advanced Non-Small-Cell Lung Cancer Who harboring EGFR mutation.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005934

Enrollment

Registered

2011-07-05

Start date

2011-07-01

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

Non Small Cell Lung Cancer

Interventions

Bevacizumab, Erlotinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) StageIIIB/IV or postoperative recurrence Non-small cell lung cancer and Non-Squamous cell carcinoma proven by histology and/or cytology 2) No prior chemotherapy except for Bevacizumab containing regimen as 1st line treatment. 3) Patients who completed more than three cycles of Bevacizumab containing regimen and experienced PD. 4) EGFR mutation (Exon19 or Exon21) 5) More than 20 years old. 6) PS 0-2 7) At least one or more measurable lesion by RECIST. 8) Interval -Palliative radiotherapy >2wks -Surgery >4wks -thoracic drainage>2wks -biopsy with dissection, indwelling port >2wks -aspiration biopsy cytology >1wks 9) Adequate organ function 10) Life expectancy more than three months. 11) Written Informed Consent

Exclusion criteria

Exclusion criteria: 1) Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.). 2) EGFR-TKI resistance EGFR mutation (T790M) 3) Prior treatment with Gefitinib or Erlotinib. 4) Unavailability of oral administration. 5) History of hemoptysis. 6) Tumor invasion to major vessels 7) History of gastrointestinal perforation or diverticulitis or fistula 8) History of cardiac infarction or brain infarction. 9) Scheduled operation. 10) Uncontrollable hypertension. 11) Symptomatic brain metastasis. 12) A history of allergic reaction for the treatment drugs. 13) Uncontrollable pleural effusion or peritoneal effusion. 14) History of severe comorbidity disease. 15) History of active double cancer. 16) Unstable psychic disorder. 17) Pregnant patients. 18) Decision of ineligibility by a physician.

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	—

Secondary

Measure	Time frame
Response Rate, Disease Control Rate, Overall Survival, Safety	—

Countries

Japan

Contacts

Public ContactTakashi Yokoi

Kansai Medical University Hirakata Hospital Respiratory medicine

yokoit@hirakata.kmu.ac.jp072-804-0101

Outcome results

None listed

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