Phase II study of carboplatin and pemetrexed plus bevacizumab after failure of first-line EGFR TKI therapy for non-small-cell lung cancer harboring EGFR mutation.

Phase II study of carboplatin and pemetrexed plus bevacizumab after failure of first-line EGFR TKI therapy for non-small-cell lung cancer harboring EGFR mutation. - Phase II study of carboplatin and pemetrexed plus bevacizumab after failure of first-line EGFR TKI therapy for non-small-cell lung cancer harboring EGFR mutation.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004731

Enrollment

Registered

2010-12-15

Start date

2010-12-02

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

Carboplatin AUC=5 day 1+ Pemetrexed 500mg/m2 day 1+ Bevacizumab 15 mg/kg day 1 q3w 4 cycles followed by Pemetrexed 500mg/m2 day 1 + Bevacizumab 15 mg/kg day 1 q3w until disease progression

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically proven non-squamous non-small cell lung cancer 2) Non-squamous non-small-cell lung cancer harboring EGFR mutation 3) Stage IIIB, stage IV (UICC-7) or recurrent disease after surgery 4) Failure after the first-line EGFR TKI therapy 5) With measurable lesion (RECIST version 1.1) 6) Without previous radiotherapy to the primary tumor 7) Age: 20-74 years old 8) ECOG performance status of 0 or 1 9) Adequate organ function 10) Life expectancy more than 3 months 11) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Symptomatic brain metastasis 2) Hemoptysis (>=2.5ml) 3) Tumor invasion to the large blood vessel 4) Uncontrolled hypertension 5) Active infection 6) Severe underlying disease such as uncontrolled heart disease or diabetes mellitus 7) Receiving anticoagulants 8) Other concurrent active malignancy 9) Superior vena cava syndrome 10) Massive pleural or pericardial effusion, or ascites 11) Vertebral metastases requiring radiation therapy 12) Severe drug allergy 13) Active GI bleeding or inflammation in the abdominal cavity 14) Major surgery within 4 weeks 15) Pregnant or breast-feeding woman

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Progression free survival Overall survival Disease control rate 1 year survival rate Adverse events	—

Countries

Japan

Contacts

Public ContactKosuke Takahashi

Aichi Cancer Center Aichi Hospital Department of Respiratory Medicine

ktakahashi@acc-aichi.com0564-21-6251

Outcome results

None listed

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