Phase II trial of adjuvant chemotherapy with carboplatin plus TS1 followed by maintenance TS1 in patients with completely resected stage II/IIIA non-small cell lung cancer. (JNETS1302)

Phase II trial of adjuvant chemotherapy with carboplatin plus TS1 followed by maintenance TS1 in patients with completely resected stage II/IIIA non-small cell lung cancer. (JNETS1302) - Adjuvant trial of CBDCA+TS1 followed by TS1 in completely resected stage II/IIA lung cancer. (JNETS1302)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011306

Enrollment

Registered

2013-07-29

Start date

2013-10-04

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

Carboplatin+TS1 followed by TS1 maintenance

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. ECOG performance status are 0 or 1. 2. Pathologically confirmed non-small cell lung cancer (NSCLC), except for low grade carcinoma such as carcinoid, mucoepidermoid carcinoma or adenoid cystic carcinoma. 3. Completely resected NSCLC by lobectomy or more 4. Lymph nodes dissection must be performed at the level of ND2a-1 5. Pathologically confirmed R0 resection. 6. Pathological stage II or IIIA 7. Within 2 months after surgical treatment 8. With adequate major organ functions within 14 days before trial entry, as defined below: 1) White blood cell count >= 3,000/mm3 2) Neutrophil count >= 1,500/mm3 3) Hemoglobin >= 8.0 g/dL 4) Platelet count >= 100,000/mm3 5) AST <= 100IU/L 6) ALT <= 100IU/L 7) Total Bilirubin<= 1.5 mg/dL 8) Serum Creatinine <= 1.5 mg/dL 9) SpO2 >= 95% at room air 10. Written informed consent must be taken by patients

Exclusion criteria

Exclusion criteria: 1. With interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray 2. With history of radiotherapy and/or chemotherapy for other disease including other cancer 3. With synchronous or metachronous (within 5 year before entry) multiple lung cancer 4. With synchronous or metachronous (within 5 year before entry) double cancer, except for curable cancer by local therapy such as in situ carcinoma 5. Severe surgical complication 6. Severe drug allergy 7. Severe complication; such as uncontrollable diabetes mellitus or hypertension 8. Positive for HBs antigen, HBs antibody, HBC antibody, HCV antibody or HIV antibody 9.Lactating, pregnant or possibly pregnant women, or those willing to become pregnant 10. Men who have willing to become partner's pregnant 11.Physician concludes that the patient's participation in this trial is inappropriate

Design outcomes

Primary

Measure	Time frame
The ratio of the patients who completed the treatment	—

Countries

Japan

Contacts

Public ContactChiaki Endoh

Tohoku University, school of medicine Department of Thoracic surgery

endo@idac.tohoku.ac.jp022-717-8526

Outcome results

None listed

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