Phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous and Non- Small Cell Lung Cancer harboring EGFR mutation who acquired resistance to prior gefitinib treatment (TAILORED-1 study)

Phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous and Non- Small Cell Lung Cancer harboring EGFR mutation who acquired resistance to prior gefitinib treatment (TAILORED-1 study) - Phase II study of Erlotinib Plus Bevacizumab in patients with advanced Non-squamous and Non- Small Cell Lung Cancer harboring EGFR mutation who acquired resistance to prior gefitinib treatment (TAILORED-1 study)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006457

Enrollment

Registered

2011-10-03

Start date

2011-10-01

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

Erlotinib 150mg/day, oral daily Bevacizumab 15mg/kg, intravenous q3w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically confirmed non-squamous NSCLC 2)StageIIIB/IVor postoperative recurrence NSCLC 3)EGFR mutation(exon18,19,21) postive 4)The best response to prior gefitinib treatment is more than SD 5)Failed to prior chemotherapy or chemoradiotherapy(<3 regimens) 6)Measurable lesions(RECIST) 7)ECOG PS 0-2 8)Age>=20years 9)Expected survival over 3 months 10)Interval i)Palliative Radiation Therapy /More than 2 weeks ii)Operation(except chest) /More than 4 weeks iii)Treatment of Brain metastasis /More than 4 weeks iv)Cranial nerves surgery /More than 3 months v)Thoracic drainage /More than 2 weeks vi)Incisional biopsy, Port detention, Measures against externally caused injury /More than 2 weeks vii)Aspiration cytology /More than 1week 11)Adequate function of main organ 12)Provided written informed consent

Exclusion criteria

Exclusion criteria: 1) Squamous cell carcinoma 2)Interstitial pneumonia or pulmonary fibrosis on chest CT scans 3) i)Brain metastasis expected bleeding ii)Patients with untreated Brain metastasis 4)Active severe comorbidity disease 5)History of hemoptysis 6)Uncontrollable hypertension 7)History of gastrointestinal perforation or diverticulitis or fistula 8)Scheduled operation 9)History of grave drug allergic reaction 10)Active concomitant malignancy 11)Pregnant or breast-feeding females 12)Inappopriate patients for this study by the physicians

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 ContactTaishi Harada

Graduate school of medical science, Kyushu University Research Institute for disease of the Chest

Harada-t@kokyu.med.kyushu-u.ac.jp092-642-5378

Outcome results

None listed

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