Phase II study of Durvalumab (MEDI4736) Plus Concurrent Radiation Therapy in Advanced Localized NSCLC Patients(Dolphin study: WJOG11619L)

JRCT ID: jRCT2080224763

Registered date:03/07/2019

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: non-small-cell lung cancer
• Date of first enrollment: 04/10/2019
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : durvalumab
INN of investigational material : durvalumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 10 mg/m2 as an IV infusion once every 2 weeks (14 days)

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome

efficacy
Progression free survival rate at 12 months

Secondary Outcome

safety
efficacy
Progression free survival, progression free survival rate at 18 months, overall survival, treatment completion rate, duration of response, response rate, disease control rate, duration to death or metastasis, safety and difference of efficacy in patient background/PD-L1 expression.

Key inclusion & exclusion criteria

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

Include criteria

(Inclusion criteria for 1st registration)
1.Patients with a histologically confirmed diagnosis of NSCLC
2.Patients with measurable disease as defined by the RECIST version 1.1
3.Patients who were not previously treated with chemotherapy for ling cancer
4.ECOG PS 0 or 1
(Inclusion criteria for 2nd registration)
1.PD-L1 expression >=1% (SP263)
2.Patients who are confirmed to be stage IIIA/IIIB/IIIC clinically according to General Rule for Clinical and Pathological Record of Ling cancer (the 8th edition)
3.Possible to start radiation therapy based on the protocol in this study.

Exclude criteria

1.Patients with active other cancers except for NSCLC
2.Patients with a past or current history of interstitial lung disease evident on CT scans,
3.Patients with a history of immune antibody therapy and other immunotherapy
4.Pregnant women, lactating women, women who may be pregnant at present.

Related Information

• Primary Sponsor: Motoko Tachihara (Coordinating Investigator)
• Secondary Sponsor: -
• Source(s) of Monetary Support: AstraZeneca K.K.
• Secondary ID(s): JapicCTI-194840