Phase I/II trial of weekly nab-paclitaxel as second- or third-line treatment in patients with advanced non-small-cell lung cancer(OLCSG1303)

Phase I/II trial of weekly nab-paclitaxel as second- or third-line treatment in patients with advanced non-small-cell lung cancer(OLCSG1303) - Phase I/II trial of weekly nab-paclitaxel as second- or third-line treatment in patients with advanced non-small-cell lung cancer (OLCSG1303)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012404

Enrollment

Registered

2013-11-27

Start date

2013-11-26

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

Interventions

nab-PTX 100mg/m2 administration on day1, 8, 15, 22 intravenously q 4 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologicaly or cytologicaly confirmed advanced non-small cell lung cancer. Wild type EGFR gene mutation (Unknown EGFR gene mutation status is allowed for squamous cell carcinoma). ALK fusion gene is negative or unknown. One or two prior regimens containing a platinum-based chemotherapy. Eastern Cooperative Oncology Group performance status 0-2. Patient has measurable lesion(s) according to the RECIST ver.1.1 criteria Adequate organ functions

Exclusion criteria

Exclusion criteria: a case who has a history of paclitaxel or nab-paclitaxel treatment. a case with symptom(s) caused by brain metastasis or a case with meningeal dissemination. a case who has treated with thoracic radiotherapy within 4 weeks or radiotherapy for other site(s) within 2 weeks a case who has major concomitant disease as interstitial lung disease, severe cardiac disease(unstable angina pectoris, history of myocardial infarction, uncontrolled arrhythmia, severe diabetes mellitus, active infection, HBV/ HCV hepatitis or liver cirrhosis ) a case who met contraindications on a nab-PTX package leaflet.

Design outcomes

Primary

Measure	Time frame
Objective Response Rate	—

Secondary

Measure	Time frame
safety and tolerability profile, progression-free survival, overall survival	—

Countries

Japan

Contacts

Public ContactDaijiro Harada

National Hospital Organization Shikoku Cancer Center Department of Thoracic Oncology

daharada@shikoku-cc.go.jp81899991111

Outcome results

None listed

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