A prospective multi-institutional observational study to explore novel biomarkers of chemo-radiation therapy combined with durvalumab to patients with unresectable stage III non-small cell lung cancer (WJOG11518L)

A prospective multi-institutional observational study to explore novel biomarkers of chemo-radiation therapy combined with durvalumab to patients with unresectable stage III non-small cell lung cancer (WJOG11518L) - A prospective multi-institutional observational study to explore novel biomarkers of durvalumab treatment in patients with stage III non-small cell lung cancer (WJOG11518L)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000035916

Enrollment

135

Registered

2019-02-18

Start date

2019-04-09

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

Locally advanced non-small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) provision of written informed consent 2) age of 20 years old or older 3) pathological diagnosis of non-small cell lung cancer (not mucoepidermoid carcinoma, adenoid cystic carcinoma, and large cell neuroendocrine carcinoma) 4) provision of archival tumor tissue obtained prior to chemo-radiotherapy (10-25 slices [4 micro meters in thickness]) 5) provision of peripheral blood sample before durvalumab therapy 6) locally advanced unresectable stage III non-small cell lung cancer according to version 8 TNM classification 7) no evidence of disease progression after definitive chemo-radiotherapy (>=54Gy of thoracic radiation therapy and 2 cycles of platinum based chemotherapy), and durvalumab therapy (10mg/kg every 2 weeks) is planned to start within 42 days after the last dose of radiation 8) ECOG PS of 0 or 1

Exclusion criteria

Exclusion criteria: 1) previous treatment with PD-1 or PD-L1 inhibitor treatment 2) postoperative recurrence of non-small cell lung cancer

Design outcomes

Primary

Measure	Time frame
Association of biomarkers with progression-free survival	—

Secondary

Measure	Time frame
Association of biomarkers with overall survival, association of biomarkers with immune-related adverse event, association of biomarkers with response rate, association of biomarkers with disease control rate, cut-off values of biomarkers, association of biomarkers with immune-related gene expression, association among biomarkers	—

Countries

Japan

Contacts

Public ContactShinichiro Nakamura

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results