Phase I/II study of TS-1 and CBDCA combination chemotherapy in elderly patients with advanced non-small-cell lung cancer

Phase I/II study of TS-1 and CBDCA combination chemotherapy in elderly patients with advanced non-small-cell lung cancer - Phase I/II study of TS-1 and CBDCA combination chemotherapy in elderly patients with advanced non-small-cell lung cancer(TCOG1101)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007049

Enrollment

Registered

2012-01-18

Start date

2012-02-01

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

Advanced non-small-cell lung cancer in elderly patients

Interventions

Level0 CBDCA :AUC4(day1)+ S-1:65mg/m2(day1-14) q3weeks Level1 CBDCA :AUC4(day1)+ S-1:80mg/m2(day1-14) q3weeks Level2 CBDCA :AUC5(day1)+ S-1:80mg/m2(day1-14) q3weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with histlogically or cytologically confirmed non-small cell lung cancer 2)Patients with clinical stage of IIIB-IV or recurrence after operation 3)Elderly patients over 75 years old 4)ECOG Performance status 0-1 5) Expected survival more than 3 months 6)A measurable lesion according to the Response Evaluation Criteria in Solid Tumors 7) With ability of oral intake 8)No prior chemotherapy nor radiation therapy 9)Adequate bone marrow reserve and organ function 10)Written IC

Exclusion criteria

Exclusion criteria: 1)Patients with interstitial pneumonia or pulmonary fibrosis on Chest X-ray 2)Patients with pleural or pericardial effusion ,or ascites 3) Patients with active double cancer 4)Patients with significant complications a) Uncontrolled angina pectoris, myocardial infarction, heart failure within 3 months b)Uncontrolled diabetes or hypertension c)Current severe infection, or suspicious of severe infection d) Patients whose participation in the trial is judged to be inappropriate by the attending doctor. (e.g., ileus, bleeding tendency, diarrhea and varicella) 5)Patients with symptomatic brain metastasis 6)Patients with pregnancy or lactation 7) History of serious drug allergy 8) History of serious allergic reaction with CBDCA or other platinum-containing drug 9) History of serious allergic reaction with S-1 10) Being treated with other pyrimidine fluoride antineoplastic agents. 11) Being treated with flucytosine. 12) Any patients judged by the investigator to be unfit to participate in the study

Design outcomes

Primary

Measure	Time frame
Phase I study: MTD, RD Phase II study : Response rate in RD	—

Secondary

Measure	Time frame
Phase I study: Safety Phase II study : OS, PFS and Safety	—

Countries

Japan

Contacts

Public ContactTCOG1101study affairs office

The Tokyo Cooperative Oncology Group Clinical Study Promotion Agency

tcog1101@tcog.jp03-5401-5020

Outcome results

None listed

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