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A Phase I Study of Weekly Nab-Paclitaxel/Carboplatin in Chemotherapy-Naive Patients with Advanced Non-Small-Cell Lung Cancer

A Phase I Study of Weekly Nab-Paclitaxel/Carboplatin in Chemotherapy-Naive Patients with Advanced Non-Small-Cell Lung Cancer - A Phase I Study of Weekly Nab-Paclitaxel/Carboplatin in Chemotherapy-Naive Patients with Advanced Non-Small-Cell Lung Cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012788
Enrollment
30
Registered
2014-01-14
Start date
2014-01-14
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 untreated advanced non-small cell lung cancer

Interventions

nab-paclitaxel weekly for 3 of 4 weeks (3-weekly) with carboplatin on day 1 of each 4-week cycle

Sponsors

Department of Respiratory Medicine in Hyogo Prefectural Amagasaki Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Cytologically or histologically documented non-small cell carcinoma of the lung. 2)previously untreated recurrence with distant metastasis after surgery, or previously untreated clinical stage IV or IIIB (including only patients with no indications for curative radiotherapy) 3) age older thean 20years at the time of registration 4) Have Eastern Cooperative Oncology Group performance status (PS) of 0 or 1 5) Have measurable lesions (RECIST version1.1) 6) Have adequate organ function within 14 days before study entry leucocytes >3000/mm3 neutrophils>1,500/mm3 platelets >100,000/mm3 hemoglobin > 9g/dl], adequate hepatic function adequate renal function partial pressure of arterial oxygen>60Torr or Peripheral capillary oxygen saturation>90% 8) Have signed an informed consent document

Exclusion criteria

Exclusion criteria: 1)History of radiotherapy for a primary lesion 2)Superior vena cava syndrome 3)Hisstory of severe drug allergy 4)With massive or uncontrolled pleural effusion 5)With massive or uncontrolled pericardial effusionor ascites 6)With active infection 7)interstitial pneumoia/active lung fibrosis on chest x-ray 8)With symptomatic brain metastasis 9)active concomitant malignancy 10)Uncontrolled psychiatric disease 11)Peripheral sensory or motor neuropathy severe than Grade 2(by CTCAE ver4.0) 12)Others judged by attending physician

Design outcomes

Primary

MeasureTime frame
determine the recommended dose

Secondary

MeasureTime frame
Safety, Efficacy

Countries

Japan

Contacts

Public ContactKatsuya Hirano

Hyogo Prefectural Amagasaki Hospital Department of Respiratory Medicine

khirano1979@gmail.com06-6482-1521

Outcome results

None listed

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