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Combination chemotheraoy of abraxane and carboplatin in elderly patients with advanced squamous cell lung cancer, phase 1/2 study (TORG1322)

Combination chemotheraoy of abraxane and carboplatin in elderly patients with advanced squamous cell lung cancer, phase 1/2 study (TORG1322) - Abraxane + CBDCA in elderly patients with advanced squamous cell lung cancer, phase 1/2 study (TORG1322)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011216
Enrollment
40
Registered
2013-07-18
Start date
2014-04-01
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

Advanced squamous cell lung cancer in elderly patients

Interventions

Carboplatin and abraxane

Sponsors

Thoracic Oncology Research Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically proven squamous cell lung cancer 2) Stage IV or stage III without any indications for radiotherapy 3) No prior chemotherapy 4) ECOG performance status 0-1 5) Measurable disease (RECIST ver.1.1) 6) Aged >=75 7) Adequate organ function 8) Estimated life expectancy at least 3 months 9) Written informed consent by patient

Exclusion criteria

Exclusion criteria: 1) Active multiple malignancy 2) History of hypersensitivity for albumin products 3) Severe drug allergy 4) Within 2 weeks after palliative radiotherapy 5) Uncontrolled symptomatic brain metastasis 6) Uncontrolled pleural effusion, ascites, and pericardial effusion which needs drainage 7) Uncontrollable ulcer of digestive tract or diabetes 8) Interstitial pneumonia 9) Psychiatric disease or symptoms, who seem to have difficulty in participating in the study 10) Other severe complications 11) Judged to be not suitable by the attending physician

Design outcomes

Primary

MeasureTime frame
<Phase I portion> To determine the recommended dose <Phase II portion> Progression-free survival rate at 6 months

Secondary

MeasureTime frame
Overall survival (OS) Progression-free survival (PFS) Response rate(RR) Rate of adverse events

Countries

Japan

Contacts

Public ContactYoshitaka Zenke

National Cancer Center Hospital East Department of Thoracic Oncology

siniho@east.ncc.go.jp04-7133-1111

Outcome results

None listed

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