NIV vs NIV+DTX Phase II/III (CONDUCT study)

JRCT ID: jRCTs031180331

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Lung cancer
• Date of first enrollment: 11/12/2017
• Target sample size: 350
• Study type: Interventional

Intervention(s)

arm A:nivolumab given on day 1 and day15 every 4 weeks until disease progression or unmanageable toxicity.
arm B:nivolumab given on day 1 and day15 and docetaxel given on day 1, every 4 weeks until disease progression or unmanageable toxicity.

Outcome(s)

Primary Outcome

PhaseII:Progression-free survival rate of 6 months, Pneumonitis rate Grade3 or more
PhaseIII:Overall survival

Secondary Outcome

PhaseII:Response rate, Adverse event rate
PhaseIII:Progression-free survival, Response rate, Adverse event

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Okamoto Hiroaki
• Source(s) of Monetary Support: Ono Pharmaceutical Co. Ltd,Bristol-Myers Squib K.K.
• Secondary ID(s): UMIN000021813