SC-103

A multicenter, randomized, controlled trial of S-1/Cisplatin vs. Docetaxel/Cisplatin for treatment of untreated advanced lung cancer.

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221440

Enrollment

240

Registered

2011-04-25

Start date

2011-04-25

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

Untreated Stage IIIB, Stage IV or postoperatively recurrent lung cancer.

Interventions

investigational material(s) Generic name etc : S-1/Cisplatin INN of investigational material : S-1: tegafur, gimeracil, oteracil potassium, CDDP: cisplatin Therapeutic category code : 429 Other antitu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with untreated Stage IIIB or Stage IV, postoperatively recurrent non-small cell lung cancer diagnosed by pathological examination. 2) Patients with RECIST-evaluable lesions. 3) Patients with good bone marrow, liver and renal functions. 4) Patients who provided the written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients who received adjunctive therapy within 1 year before registration. 2) Patients with an allergic history of the investigational drug. 3) Patients with severe complications, brain metastases, multiple carcinoma, or active infection. 4) Patients with active pleural fluid, ascites or pericardial effusion. 5) Pregnancy and breast-feeding women or cases with a child-bearing plan.

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival Kaplan-Meier method is used for PFS of FAS	—

Secondary

Measure	Time frame
Objective Response Rate, Overall Survival, Time to Treatment Failure, Adverse Event and Adverse Drug Reaction RECIST, CTCAE	—

Outcome results

None listed

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