IV vs NIV+DTX Phase II/III (CONDUCT study)
- Conditions
- ung cancerLung cancer
- Registration Number
- JPRN-jRCTs031180331
- Lead Sponsor
- Okamoto Hiroaki
- Brief Summary
The combination of nivolumab and docetaxel was associated with increased adverse events compared to nivolumab alone. However, the combination of nivolumab and docetaxel was considered to be a significantly better and more promising treatment than nivolumab monotherapy, as the primary endpoint was met and study treatment B was significantly better than standard treatment A in the secondary efficacy endpoint.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 131
1.Histologically or cytologically confirmed NSCLC.
2.Previously treated, at least one regimen cytotoxic chemotherapy, and stage III or IV or post operation recurrence.
3.Less than 2 regimen previous chemotherapy. EGFR-TKI and ALK-TKI are not regarded as regimen.
4.Aged 20 years or older.
5.ECOG performance status 0 to 1.
6.Written informed consent.
1.Previously treated by docetaxel.
2.Previously treated by antibody targeting to PD-1, PD-L1, PD-L2, CD137, or CTLA-4.
3.Synchronous or metachronous (within 5 years) malignancies, except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
4.Active CNS metastasis or meningitis carcinomatous. (If patients were received brain radiation, and stable clinically, it is eligible.)
5.Evident interstitial pneumonia in CT.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PhaseII:Progression-free survival rate of 6 months, Pneumonitis rate Grade3 or more <br>PhaseIII:Overall survival
- Secondary Outcome Measures
Name Time Method PhaseII:Response rate, Adverse event rate<br>PhaseIII:Progression-free survival, Response rate, Adverse event