臨床研究等提出・公開システム

A prospective multicenter single-arm study evaluating the efficacy and safety of adjuvant carboplatin plus nanoparticle albumin-bound paclitaxel in patients with non-small cell lung cancer complicated by interstitial lung disease

A multicenter prospective study of adjuvant carboplatin plus nab-paclitaxel for non-small cell lung cancer with interstitial lung disease

Okuda Katsuhiro

Nagoya City University Hospital

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8602, Aichi

kokuda@med.nagoya-cu.ac.jp

Nakamura Ryuji

Nagoya City University Hospital

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi

+81-52-851-5511

n_ryuji@med.nagoya-cu.ac.jp

Recruiting

Aug. 14, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(1) Patients with pathologically confirmed stage IIA-IIIB non-small cell lung cancer (NSCLC) according to the 9th edition of the General Rules for Clinical and Pathological Record of Lung Cancer.
(2) Patients who have undergone lobectomy or segmentectomy.
(3) Patients who were diagnosed, based on preoperative chest CT findings reviewed at a multidisciplinary conference involving pulmonologists and radiologists, as having one of the following imaging patterns, and who were considered unsuitable for postoperative adjuvant chemotherapy with cisplatin plus vinorelbine:
- Usual interstitial pneumonia (UIP) pattern
- Probable UIP pattern
- Indeterminate for UIP pattern
(4) Patients who have undergone complete resection of the pulmonary lesion, including metastatic lymph nodes.
(5) Patients aged 18 to 80 years at the time of registration.
(6) Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at the time of registration.
(7) Patients who are able to initiate the study treatment within 8 weeks after surgery.
(8) Patients who have provided written informed consent to participate in this study.

(1) Patients with a history of acute exacerbation of interstitial pneumonia.
(2) Patients who meet any of the following criteria on preoperative pulmonary function testing:
- Percent diffusing capacity of the lung for carbon monoxide (%DLCO) less than 55%
- Percent forced vital capacity (%FVC) less than 75%
(3) Patients who meet any of the following laboratory criteria at the time of registration:
- Neutrophil count 1,500/mm3 or lower
- Platelet count 100,000/mm3 or lower
(4) Patients receiving continuous systemic administration of corticosteroids or other immunosuppressive agents at the time of registration.
(5) Patients who have received neoadjuvant therapy (chemotherapy, radiotherapy, or immune checkpoint inhibitors).
(6) Patients with a history of allergic reactions to platinum-based agents, paclitaxel, or albumin preparations
(7) Patients who are scheduled to receive atezolizumab following postoperative chemotherapy.
(8) Patients with severe comorbidities (including but not limited to persistent diarrhea, active infection, hepatic dysfunction, renal dysfunction, poorly controlled diabetes mellitus, history of myocardial infarction within 6 months prior to registration or unstable angina, cor pulmonale, pulmonary hypertension) or varicella infection.
(9) Women who are pregnant, breastfeeding, of childbearing potential with a possibility of pregnancy, or intending to become pregnant.
(10) Patients who are deemed inappropriate for participation in this study by the principal investigator or sub-investigator.

Both

Non-small cell lung cancer complicated by interstitial lung disease

Participants will receive postoperative adjuvant chemotherapy consisting of carboplatin and nanoparticle albumin-bound paclitaxel (nab-paclitaxel).
Carboplatin will be administered intravenously on Day 1 of each 28-day cycle at a target area under the curve (AUC) of 6 mg min/mL, calculated using the Calvert formula.
Nab-paclitaxel will be administered intravenously at a dose of 100 mg/m2 on Days 1, 8, and 15 of each 28-day cycle.
Treatment will be repeated every 4 weeks for a total of 4 cycles unless disease recurrence, unacceptable toxicity, withdrawal of consent, or investigator decision occurs.
Dose modifications and treatment delays will be performed according to the protocol-defined criteria.

Nonsmall cell lung cancer

chemotherapy

D002289

D017024

2-year disease-free survival rate

(1) Incidence of acute exacerbation of interstitial lung disease
(2) 3-year disease-free survival rate
(3) Incidence of adverse events and serious adverse events

+81-52-853-8346

July. 22, 2026

No

none