Phase II study of bevacizumab in combined with carboplatin plus pemetrexed for patients with untreated non-squamous non-small cell lung cancer with brain metastases.

Phase II study of bevacizumab in combined with carboplatin plus pemetrexed for patients with untreated non-squamous non-small cell lung cancer with brain metastases. - Phase II study of bevacizumab in combined with carboplatin plus pemetrexed for patients with untreated non-squamous non-small cell lung cancer with brain metastases. (STOG1301)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013010

Enrollment

Registered

2014-02-01

Start date

2013-12-02

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, pemetrexed and bevacizumab followed by maintenance pemetrexed and bevacizumab.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed non-squamuous, non-small cell lung cancer and stage IV or recurrent non-small cell lung cancer 2) Brain metastasis. The number of Brain metastasis is not limited. - Asymptomatic - No bleeding or progress - Neurosurgical extraction operation > 3 months - The radiation therapy for the brain metastasis > 2 wks - Diameter of maximum brain metastasis site < 1.5 cm 3) Untreated patient without adjuvant fluoropyrimidine or EGFR-TKI - No prior Pemetrxed or Bevacizumab 4) Aged 20 years or over 5) ECOG Performance Status 0-1 6) With one or more measurable lesions based on RECIST version 1.1 7) Adequate organ function, as - WBC > or = 4,000/mm3 - Neu > or = 2,000/mm3 - Plt > or = 10.0x10,000/mm3 - Hemoglobin > or = 9.0g/dL - AST/ALT < or = 100 IU/L - T-bil < or = 1.5mg/dL - Cre < or = 1.2mg/dL - Creatinine clearance > or = 45ml/min - SpO2(Room air) > or = 90% - Proteinuria < or = 1+ 8) Interval - Palliative radiotherapy > or = 2 wks - Lobectomy Operation > or = 8 wks - Another surgery > or = 4 wks - Thoracic drainage, Pleurodesis > or = 2 wks 9) Written informed consent from the patients.

Exclusion criteria

Exclusion criteria: 1) Antiedema agent treatment for a brain metastasis 2) Bleeding of the brain metastasis 3) Carcinomatous meningitis 4) Squamous cell dominant 5) Small cell lung carcinoma cells are contained. 6) Cerebral amyloid angiopathy 7) Current or previous history of hemoptysis 8) Current or previous history of continuing bloody sputum - History of continuing bloody sputum within 3 months - Current or previous history of continuing taking a oral hemostatic agent - Need to treat intravenous hemostatic agent for sputum 9) Have received radiation therapy to lesions of the lung 10) Have received therapy to primary lesion 11) Evidence of tumor invading large vessel on imaging 12) Severe infection 13) Severe complications 14) Uncontrolled ascites, pleural effusion or pericardial effusion 15) Active concomitant malignancy 16) History of severe drug allergy 17) Active interstitial pneumonitis or pulmonary fibrosis on chest CT scans 18) Uncontrollable hypertension < 160/100 19) History of symptomatic cerebrovascular disease 20) Need to antiplatelet therapy or anticoagulation therapy without Aspirin 325 mg/day 21) Uncontrolled ulcer 22) Gastrointestinal perforation within 1 year 23) Inappropriate for this study judged by the attending physician

Design outcomes

Primary

Measure	Time frame
progression free survival (PFS)	—

Secondary

Measure	Time frame
Safety RR; response rate DCP; disease Control proportion OS; overall survival IPF; intracranial PFS TBTF; time to Bev treatment failure	—

Countries

Japan

Contacts

Public ContactSeisuke Nagase

International University of Health and Werfare Respiratory Disease Center

snagase@iuhw.ac.jp03-3451-8121

Outcome results

None listed

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