SC-103
Phase 3
- Conditions
- ntreated Stage IIIB, Stage IV or postoperatively recurrent lung cancer.
- Registration Number
- JPRN-jRCT2080221440
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 240
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-Free Survival<br>Kaplan-Meier method is used for PFS of FAS
- Secondary Outcome Measures
Name Time Method Objective Response Rate, Overall Survival, Time to Treatment Failure, Adverse Event and Adverse Drug Reaction<br>RECIST, CTCAE