PhaseI/II study of carboplatin plus nab-paclitaxel plus bevacizumab administered to advanced non-squamous non-small cell lung cancer.

PhaseI/II study of carboplatin plus nab-paclitaxel plus bevacizumab administered to advanced non-squamous non-small cell lung cancer. - PhaseI/II study of carboplatin plus nab-paclitaxel plus bevacizumab administered to advanced non-squamous non-small cell lung cancer.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013333

Enrollment

Registered

2014-03-04

Start date

2014-02-20

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

advanced non-squamous non-small cell lung cancer

Interventions

phaseI Carboplatin and bevacizumab will be administered by fixed dose on day1, and nab-paclitaxel (nab-PTX) at the dose levels as described below. level 0: nab-PTX (75mg/m2) day1,8 carb

(2)grade 3 or 4 febrile neutropenia

(3)grade 4 thrombocytopenia

(4)grade 3 or 4 non-hematologic toxicity, excluding nausea and vomiting

(5)grade 4 hypertension

(6)skipping of day8 or day15 administration

and (7)not fulfill the criteria for starting second cycle therapy on day22. phase II Recommended dose of nab-PTX plus carboplatin and bevacizumab therapy will be administered every three weeks up

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)histologically or cytologically confirmed non-squamous non-small cell lung cancer. (2)Stage IIIB, out of radical setting radiotherapy/IV,M1a/IV, M1b (3) ECOG PS 0 or 1 (4)Measurable or nonmeasurable disease as defined by RECIST criteria (5)No prior chemotherapy (6)Adequate bone marrow, renal, and hepatic parameters (7)No history of major hemoptysis (8)Informed consent

Exclusion criteria

Exclusion criteria: (1) Hemorrhagic Diathesis, coagulopathy (2) Presence of cardiovascular invasion (3) Presence of any tumor with cavitation (4) Presence of significant interstitial lung disease or lung fibrosis (5) Uncontrolled intercurrent illness (eg. hypertension, diabetes mellitus, gastro- intestinal fistula, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia) (6) Ongoing/active infection (7) Arterial thrombotic events or significant vascular disease (8) Uncontrolled gastric ulcer (9) Gastrointestinal perforation within the past 12 months (10) Prior malignancy (11) Uncontrolled pleural effusion or ascites (12) Clinically significant pericardial effusion (13) Hypersensitivity history for test drugs (14) Pregnancy or breast-feeding

Design outcomes

Primary

Measure	Time frame
phase I: to determine recommended dose phaseII: response rate	—

Secondary

Measure	Time frame
phaseII:to evaluate disease control rate, progression free survival, overall survival and safety profile	—

Countries

Japan

Contacts

Public ContactKenji Akita

Nagoya City West Medical Center respiratory medicine

k.akita.86@west-med.jp052-991-8121

Outcome results

None listed

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