A Phase II study of q4w carboplatin plus nab-paclitaxel in chemo-naive patients with squamous cell lung cancer (OSAKA-LCSG1302)

A Phase II study of q4w carboplatin plus nab-paclitaxel in chemo-naive patients with squamous cell lung cancer (OSAKA-LCSG1302) - A Phase II study of q4w carboplatin plus nab-paclitaxel in chemo-naive patients with squamous cell lung cancer (OSAKA-LCSG1302)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011897

Enrollment

Registered

2013-10-01

Start date

2013-10-01

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

Chemo-naive patients with squamous cell lung cancer

Interventions

nab-PTX 100mg/m2 (day1, 8, 15) + Carboplatin (AUC = 6, day 1) q4weeks 4cycles followed by nab-PTX 100mg/m2 (day1, 8, 15) q4weeks until disease progression

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically or cytologically confirmed squamous cell lung cancer 2.Stage III/IV without any indications for radiotherapy, or recurrent disease after surgery 3.chemo-naive 4.If 12 months or more pass, the adjuvant chemotherapy is not assumed to be a previous chemotherapy 5.The picibanil used by the pleurodesis is assumed to be registrable 6.EGFR, ALK, and MET inhibitor mono-therapy does not mean previous chemotherapy 7.The patients have not been conducted radiation therapy (Except for applied palliative radiation for the primary tumor) 8.Measurable disease 9.Age 20-74 10.ECOG performance status of 0 to 1 11.Adequate organ function, evaluated within 14 days before enrollment as; Neu >= 1,500 /mm3 Plt >= 100,000 /mm3 hemoglobin >= 9.0 g/dL ALT (GPT) =< 100 IU/L T. bil =< 1.5 mg/dL Cr >= 1.5mg/dL SpO2 >= 95% or >= 60 torr 12.Expected to live over 3 months after administration days 13.Written informed consent from the patients

Exclusion criteria

Exclusion criteria: 1.Adjuvant chemotherapy of PTX 2.Active synchronous malignancy 3.Symptomatic brain metastasis 4.Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage 5.>= G2 peripheral neuropathy 6.Pneumonia or Pulmonary fibrosis detectable on chest X-rays. 7.serious complication ischemic heart disease, cardiac arrhythmia, post-MI, hepatic cirrhosis, gastrointestinal ulcer, DM 8.History of severe drug allergy 9.Women with a possibility of pregnancy, pregnant or lactating 10.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 (PFS), PFS in cases given maintenance therapy, Overall survival (OS), Maintenance extraction rates, 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