A phase II study of Carboplatin+Pemetrexed +Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR

A phase II study of Carboplatin+Pemetrexed +Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR - A phase II study of Carboplatin+Pemetrexed +Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004686

Enrollment

Registered

2010-12-08

Start date

2012-08-01

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(Non squamous)

Interventions

Carboplatin+Pemetrexed+Bevacizumab every 3 weeks. Responding patients receive Pemetrexed+Bevacizumab maintenance.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. histologically or cytologically confirmed non-squamous NSCLC 2. Stage IIIB, VI or recurrent post operative patients 3. measurable disease 4. life expectancy of at least 3 months. 5. 20>=age >75 years 6. performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale 7. adequate organ function adequate bone marrow (neutrophil count > =1,500/mm3, hemoglobin concentration > =9.0g/dL, platelet count >= 100,000 /mL), kidney (creatinine>= Cr 60), liver (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] < =institutional normal level x 2.5, total bilirubin< =institutional normal level x 1.5 ), SpO2> =93, Proteinuria< 2g 8. positive sensitizing EGFR mutations

Exclusion criteria

Exclusion criteria: 1. Radiation therapy to primary cancer 2.Active infection or other serious conditions 3. Severe pleural effusion or uncontrollable pleural effusion 4.Symptomatic brain metastasis 5. Uncontrollable hypertension 6. Uncontrollable diabetes mellitus 7. Current or previous history of hemoptysis or hemosputum 8. Current or previous (within the last 1 year) history of GI perforation 9. Interstitial pneumonia or pulmonary fibrosis detectable on CT scan 10.Tumor invasive to the chest large blood vessel. 11.Evidence of bleeding diathesis or coagulopathy 12.History of active double cancer 13.History of active psychological disease 14.History of pregnancy or lactation 15. Active concomitant malignancy 16. Active mental illness 17. Previous treatment with Carboplatin or Pemetrexed or Bevacizumab 18. History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris etc)

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
progression free survival, overall survival, time to response, safety	—

Countries

Japan

Contacts

Public ContactHirohisa Yoshizawa

Niigata University Medical and Dental Hospital Bioscience Medical Research Center

hy0522@med.niigata-u.ac.jp025-227-2517

Outcome results

None listed

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