Carboplatin and nab-Paclitaxel as first-line treatment in patients with advanced non-small cell lung cancer with interstitial lung disease (HOT1302)

Carboplatin and nab-Paclitaxel as first-line treatment in patients with advanced non-small cell lung cancer with interstitial lung disease (HOT1302) - Carboplatin and nab-Paclitaxel as first-line treatment in patients with advanced non-small cell lung cancer with interstitial lung disease (HOT1302)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012901

Enrollment

Registered

2014-01-20

Start date

2014-01-20

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-paclitaxel 100mg/m2 is administered by an infusion lasting 30 minutes on days 1, 8, 15 every 3weeks. Carboplatin AUC 6 is administered by an infusion lasting 60 minutes on day 1 following to nab-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age of 20 years or older and younger than 75 years 2) Histologically or cytologically confirmed non-small cell lung cancer 3) Clinical Stage IIIB which curative radiotherapy is not indicated, IV or postoperative recurrence 4) No prior chemotherapy 5) Patients with interstitial lung disease diagnosed by chest X-ray or Chest CT scan 6) Measurable lesion(s) 7) ECOG Performance status of 0-1 8) Sufficient major organ function 9) Life expectancy of at least 3 months 10) Written informed consent

Exclusion criteria

Exclusion criteria: 1) History of Severe drug allergies 2) CVD-IP or other ILD (e.g. pneumoconiosis) with clear cause 3) Active infection 4) Oral steroid or immunosuppressant drug 5) Severe concurrent disease 6) Postive HBs antigen or positive HBs antibody with detectable HBV-DNA 7) Pleural and peritoneal effusion likely to require surgical intervention, or pericardial effusion 8) Symptomatic brain metastasis 9) Active double cancer 10) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy 11) Previous treatment with nab-paclitaxel 12) Physician concludes that the patient's participation in this trial is inappropriate

Design outcomes

Primary

Measure	Time frame
Objective response rate	—

Secondary

Measure	Time frame
Safety, progression-free survival, overall survival	—

Countries

Japan

Contacts

Public ContactHajime Asahina

Hokkaido University Schoole of Medicine First Department of Medicine

asahinah@pop.med.hokudai.ac.jp011-706-5911

Outcome results

None listed

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