Induction Chemotherapy and Adjuvant Thoracic Radiation in Resectable Stage N2-3A/3B Non-small Cell Lung Cancer (ICAT study)

Induction Chemotherapy and Adjuvant Thoracic Radiation in Resectable Stage N2-3A/3B Non-small Cell Lung Cancer (ICAT study) - Trimodality with Adjuvant Radiation in Stage N2-3A/3B Non-small Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025010

Enrollment

Registered

2016-12-01

Start date

2018-11-01

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

Resectable Stage 3A-N2 Non-small Cell Lung Cancer

Interventions

Trimodality treatment with 3 course of induction chemotherapy with Carboplatin AUC5 and nab-Paclitaxel 100mg/m2, radical surgery more than lobectomy, adjuvant radiation 50Gy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Stage 3A non-small-cell lung cancer (NSCLC) with mediastinal lymph node metastasis (N2) confirmed pathologically without chest wall invasion 2.R0 radical surgery is expected after induction chemotherapy 3.Normal pulmonary function (%VC > 80%, FEV1% > 70%) within 56 days prior to consent 4.Chemotherapy-naive and radiotherapy-naive 5.20 - 75 years of age at enrollment 6.ECOG Performance Status 0-1 7.The latest clinical laboratory test within 28 days prior to enrollment meets the following all standard Leukocyte count > 3,000/mm3 Hemoglobin > 10.0g/dl Platelet > 100,000/mm3 Total bilirubin < 1.5mg/dl Serum albumin > 3.0g/dl AST/ALT < 100 IU Creatinine < 1.2mg/dl SpO2 > 95% 8.Patients providing the written informed consent for this trial

Exclusion criteria

Exclusion criteria: 1.Evident unresectable extranodal lymph node involvement in CT scanning 2.Contraindication to either carboplatin or nab-paclitaxel 3.History of severe drug hypersensitivity 4.Impaired pulmonary function 5.Myocardial infarction within 6 months (180 days) prior to consent 6.Interstitial pneumonia, pulmonary fibrosis suspected or diagnosed within 56 days prior to consent 7.Administration of prednisolone > 10mg/day within 90 days prior to consent 8.Clinically severe heart diseases 9.Clinically severe psychiatric diseases 10.Uncontrollable diabetes mellitus 11.Clinically active infection 12.Any other severe complication 13.Active double malignancies 14.Pregnant, lactating or possibly pregnant 15.Any other unsuitable reasons judged by attending investigators

Design outcomes

Primary

Measure	Time frame
feasibility	—

Secondary

Measure	Time frame
response rate of induction chemotherapy, safety, progression free survival	—

Countries

Japan

Contacts

Public ContactHiroaki Tsunezuka

Kyoto Prefectural University of Medicine Division of Thoracic Surgery, Department of Surgery

tsune@koto.kpu-m.ac.jp075-251-5739

Outcome results

None listed

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