Stydy of DE-766 in Patients with Unresectable Locally Advanced Squamous Cell Lung Cancer

A Randomized, Double-Blind, Placebo-controlled Phase III Study of DE-766 with Cisplatin/Vinorellbine plus Concurrent Thoracic Radiotherapy in Patients with Unresectable Locally Advanced Squamous Cell Lung Cancer

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222038

Enrollment

420

Registered

2013-03-13

Start date

2013-03-13

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

Unresectable Locally Advanced Squamous Cell Lung Cancer

Interventions

investigational material(s) Generic name etc : DE-766 INN of investigational material : Nimotuzumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with stage IIIA or IIIB of squamous cell lung cancer 2) Patients with unresectable squamous cell lung cancer 3) Patients who are judged suitable for radical radiotherapy 4) Patients who have received no prior treatment for lung cancer

Exclusion criteria

Exclusion criteria: 1) Patients with contralateral hilar lymph node metastasis 2) Patients with obvious pulmonary fibrosis or interstitial pneumonitis on chest CT scans 3) Patients with a severe pulmonary disease such as intense pulmonary emphysema, serious chronic bronchitis, or serious bronchial asthma 4) Patients with severe infection 5) Patients with severe cardiovascular disease 6) Patients with uncontrolled diabetes mellitus 7) Patients with another active malignancy 8) Patients with a history of prior radiotherapy to chest 9) Patients who have received with any EGFR targeted drug at any time 10) Patients who received another investigational drug within 4 weeks prior to randomization.

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Safety, Torelability, Progression free survival, Local controll duration, First relapse site, Response rate, Disease control rate NCI-CTCAE(ver4.0), RECIST(ver1.1)	—

Outcome results

None listed

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