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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080224763
Enrollment
35
Registered
2019-07-03
Start date
2019-10-04
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

non-small-cell lung cancer

Interventions

Sponsors

Motoko Tachihara (Coordinating Investigator)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
efficacy Progression free survival rate at 12 months

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactKazuhiko Sawa

West Japan Oncology Group

sawa@wjog.jp+81-6-6633-7400

Outcome results

None listed

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