Phase II study evaluating Erlotinib/Bevacizumab therapy as a second line therapy for advanced relapsed EGFR mutation positive non-squamous NSCLC patients who received first line combination therapy including platinum and Bevacizumab

Phase II study evaluating Erlotinib/Bevacizumab therapy as a second line therapy for advanced relapsed EGFR mutation positive non-squamous NSCLC patients who received first line combination therapy including platinum and Bevacizumab - Phase II study evaluating Erlotinib/Bevacizumab therapy as a second line therapy for advanced relapsed EGFR mutation positive non-squamous NSCLC patients who received first line combination therapy including platinum and Bevacizumab

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009603

Enrollment

Registered

2012-12-21

Start date

2012-11-01

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-squamous non-small-cell lung cancer

Interventions

Patients evaluated progression disease during platinum combination therapy including Bevacizumab, will receive Erlotinib / Bevacizumab therapy as the secondary cemotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients at the age of 20 and over 2. Confirmed as StageIIIB(unsuitable for definitive radiotherapy), StageIV, or recurrent after surgery * Patients of at least 6 months after the last course of adjuvant chemotherapy 3. non-squamous NSCLC 4. EGFR mutation positive(exon19, 21) 5. Patients with life expectancy for more than 3 months 6. Eastern Cooperative Oncology Group performance status of 0-2 7. Patients with measurable disease based on Response Evaluation Criteria in Solid Tumors(RECIST)ver.1.1. * radiation sites are not counted as measurable lesions 8. Advanced relapsed EGFR mutation positive non-squamous NSCLC patients evaluated progression disease during first line combination therapy including platinum and Bevacizumab 9. Patients with adequate organ function as following Neutrocyte count >= 1,500/mm3 Hemoglobin >= 9.0 g/dL Platelet count >= 100,000/mm3 Aspartate aminotransferase and alanine aminotransferase < 2.5 times the upper limit of normal Total bilirubin <= 1.5mg/dL Serum creatinine <= 1.5mg/dL PT-INR < 1.5 Urine protein <= +1 * Confirmed by test results within 2 weeks before registration date. The same day of the week 2 weeks before enrollment cannot be included 10. At the time of the expected date of the beginning of treatment, patients with the following period has elapsed since prior treatments No radiotherapy except for thoracic radiation within a week (exclude chest) No Exploratory thoracotomy within 4 weeks No pleural drainage within a week 11. Patients with sensitive EGFR mutation confirmed by PCR 12. Written informed consent can be obtained

Exclusion criteria

Exclusion criteria: 1. Patients treated with EGFR-TKI 2. Patients with T790M mutation 3. Patients with history or combination of interstitial lung disease (interstitial pneumonia, pneumonitis, radiation pneumonia, BOOP, pulmonary fibrosis, ARDS, pulmorary infiltration, alveolitis, etc), and lung infection 4. Patients complicated with corneal disease, which is a problem in the clinical 5. Patients with intestinal diverticulitis 6. Patients with symptomatic brain metastases 7. Patients with history or complication of hemoptysis *Definition of hemoptysis is determined as the following. A history of continuous hemoptysis over one week, or hemoptysis receiving oral or intravenous hemostatic medicine 8. Patients with a history of severe drug allergy 9. Patients with uncontrolled ascites, pleural effusion, or pericardial effusion 10. Patients with a history of gastrointestinal perforation within an year, or a complication of uncontrollable peptic ulcer 11. Patients with uncontrolled hypertension 12. Patients with infectious disease requiring systemic administration of antiviral agents, antifungal agents, or antibiotics 13. Patients receiving antiplatelet therapy *Patients receiving aspirin therapy up to 325mg are allowed to be registered 14. Patients with a history of radiation to the chest, or more than 20% region of bones with hematopoietic ability 15. Patients with multiple cancers within 5 years prior to initiation of the study, except for carcinoma in situ, mucosal cancer appropriately treated non-melanoma, cervical cancer, thyroid cancer, early gastric cancer, early colorectal cancer 16. Patients with serious complications (such as heart disease, active infection, interstitial pneumonia, diabetes) 17. Pregnant woman or those with suspected pregnancy, nursing woman and those who plan to become pregnant during the study period 18. Other patients whom the investigator considers to be unsuitable for participation in the study

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Disease control rate, Progression free survival, Overall survival, Safety, Search for predictive factors	—

Countries

Japan

Contacts

Public ContactShigeru Tanzawa

Showa University Northern Yokohama Hospital Respiratory Center

shigen1025@yahoo.co.jp045-949-7000

Outcome results

None listed

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