A phase II Study of Bevacizumab plus oral S1 previously treated non-small cell lung Cancer (OSAKA-LCSG1202)

A phase II Study of Bevacizumab plus oral S1 previously treated non-small cell lung Cancer (OSAKA-LCSG1202) - A phase II Study of Bevacizumab plus oral S1 previously treated non-small cell lung Cancer (OSAKA-LCSG1202)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008158

Enrollment

Registered

2012-07-01

Start date

2012-07-01

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

Previously treated non-small cell lung cancer

Interventions

Bevacizumab 15mg/kg (day1, 22) + S-1 80mg/m2 (day1~14) q3weeks until disease progression

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically or cytologically confirmed non-squamuous, non-small cell lung cancer 2.Stage III/IV non-small cell lung cancer without any indications for radiotherapy 3.Measurable disease 4.Patients who have previously treated with one regimen 5.EGFR, ALK, and MET inhibitor mono-therapy or combination therapy does not mean previous chemotherapy regimen 6.Adjuvant chemotherapy and Neo-adjuvant chemotherapy is not included in a postoperative regimen / at least 180 days interval from the last dosage of adjuvant chemotherapy 7.Age 20=< 8.ECOG performance status of 0 to 2 9.Patiants who can take in drug orally 10.Adequate organ function, evaluated within 14 days before enrollment as; WBC >= 3,500 /mm3 Neu >= 1,500 /mm3 Plt >= 100,000 /mm3 hemoglobin >= 9.0 g/dL AST (GOT) , ALT (GPT) =< 100 IU/L T. bil =< 1.5 mg/dL Cr >= 1.5mg/dL SpO2 >= 90% or >= 60 torr 11.Expected to live over 12 weeks after administration days 12.Written informed consent from the patients.

Exclusion criteria

Exclusion criteria: 1.Adjuvant chemotherapy 2.Pneumonia or Pulmonary fibrosis detectable on chest X-rays. History of drug induced interstitial pneumonia. 3.History of severe drug allergy 4.Active synchronous malignancies 5.Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage 6.Severe complication 7.Metastasis to CNS 8.Patients with chest radiation treatment is required to reach the lung irradiation 9.Treated by flucytosine (5-FC) 10.Symptomatic brain metastasis 11.Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Progression-free survival, Overall survival, Frequency and grade of adverse event	—

Countries

Japan

Contacts

Public ContactTakashi Kijima

Osaka University Hospital Dept. of Respiratory Medicine

tkijima@imed3.med.osaka-u.ac.jp06-6879-3833

Outcome results

None listed

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