A multicenter retrospective observational study to evaluate the efficacy and safety of durvalumab following concurrent chemoradiotherapy for stage III non-small cell lung cancer harboring EGFR mutation (NEJ063 study)

A multicenter retrospective observational study to evaluate the efficacy and safety of durvalumab following concurrent chemoradiotherapy for stage III non-small cell lung cancer harboring EGFR mutation (NEJ063 study) - NEJ063 study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051670

Enrollment

300

Registered

2023-07-20

Start date

2023-09-30

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients must be initiated on concurrent curative chemoradiotherapy between July 1, 2015 and June 30, 2022 and meet all of the following criteria. (1) Patients diagnosed with non-small cell lung cancer by histological or cytological diagnosis and confirmed positive for EGFR mutation. (2) Patients with clinical stage IIIA to IIIC at the start of chemoradiotherapy, including postoperative recurrence cases. (3) Patients who have completed chemoradiotherapy and have no evidence of disease progression at the first efficacy evaluation after completion of chemoradiotherapy (Stable disease or higher by RECIST v.1.1).

Exclusion criteria

Exclusion criteria: (1) Cases treated with sequential combination of chemotherapy and radiotherapy. (2)Cases that the physician judged to be inappropriate for reasons such as inability to collect the information necessary to fill out the CRF.

Design outcomes

Primary

Measure	Time frame
Progression free survival from the end of chemoradiotherapy in the chemoradiotherapy plus durvalumab and chemoradiotherapy alone groups	—

Secondary

Measure	Time frame
1) Overall survival from the time of completion of chemoradiotherapy in the chemoradiotherapy plus durvalumab and chemoradiotherapy alone groups 2) Progression-free survival and overall survival by year from the end of chemoradiation therapy in the chemoradiation therapy plus durvalumab and chemoradiation therapy alone groups 3) Treatment safety in patients receiving chemoradiation followed by durvalumab 4) Patient characteristics of the long-term progression-free survival cohort in the durvalumab arm 5) Safety of EGFR-TKI as post-therapy in patients treated with durvalumab	—

Measure

Time frame

1) Overall survival from the time of completion of chemoradiotherapy in the chemoradiotherapy plus durvalumab and chemoradiotherapy alone groups 2) Progression-free survival and overall survival by year from the end of chemoradiation therapy in the chemoradiation therapy plus durvalumab and chemoradiation therapy alone groups 3) Treatment safety in patients receiving chemoradiation followed by durvalumab 4) Patient characteristics of the long-term progression-free survival cohort in the durvalumab arm 5) Safety of EGFR-TKI as post-therapy in patients treated with durvalumab

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Countries

Japan

Contacts

Public ContactToshiya Fujisaki

Tachikawa General Hospital Department of Respiratory Medicine

toshiyafujisaki100@gmail.com0258-33-3111

Outcome results