Phase I/II trial of nab-PTX/CDGP for chemo-naive patients with advanced squamous cell lung cancer (KRSG-1302)

Phase I/II trial of nab-PTX/CDGP for chemo-naive patients with advanced squamous cell lung cancer (KRSG-1302) - Phase I/II trial of nab-PTX/CDGP for patients with advanced squamous cell lung cancer (KRSG-1302)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013219

Enrollment

Registered

2014-02-21

Start date

2013-07-29

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

Squamous cell lung cancer

Interventions

Phase I LEVEL2 nab-PTX: 100 mg/m2 (day1,8,15

q3w) CDGP: 100 mg/m2 (day1

q3w) LEVEL1 nab-PTX: 100 mg/m2 (day1,8, q3w) CDGP: 100 mg/m2 (day1

q3w) LEVEL0 nab-PTX: 100 mg/m2 (day1,8, q3w) CDGP: 80 mg/m2 (day1

q3w) LEVEL-1 nab-PTX: 80 mg/m2 (day1,8, q3w) CDGP 80: mg/m2 (day1

q3w) Phase II nab-PTX: RD, Recommended schedule CDGP: RD (day1

q3w)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Definitively diagnosed with squamous cell lung cancer by the specimens histologically or cytologically. 2) Stage III/IV without any indications for radiotherapy 3) No prior chemotherapy Adjuvant chemotherapy of UFT finished before 4 weeks from enrollment or more is permitted. 4) With a measurable lesion 5) Age of 20 to 75 years 6) Without active cancer other than NSCLC 7) ECOG performance status 0 or 1 8) With adequate organ function

Exclusion criteria

Exclusion criteria: 1) Symptomatic brain metastasis 2) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy 3) With active double cancer or multicentric cancer 4) .>= G2 peripheral neuropathy (CTCAE) 5) Treated with radiotherapy within the past four weeks. 6) With clinically important complications. 7) Interstitial pneumonia or pulmonary fibrosis becomes the clinical problem 8) With pleural effusion or pericardial effusion accumulates which need drainage 9) With the history of hypersensivity for component of human plasma with albumin, nab-PTX, or CDGP 10) Main organs had a serious medical risk factor, and the physicians judged treatment not to be safe. 11) Physician concludes that the patient's participation in this trial is inappropriate

Design outcomes

Primary

Measure	Time frame
Phase I: To determine the maximum tolerated dose and to estimate the recommended dose Phase II: response rate	—

Secondary

Measure	Time frame
Phase I: Safety, Response rate Phase II: Progression-free survival, Overall survival, safety	—

Countries

Japan

Contacts

Public ContactTakashi Kasai

Tochigi Cancer Center Division of Thoracic Oncology

takasai@tcc.pref.tochigi.lg.jp028-658-5151

Outcome results

None listed

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