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Ramucirumab plus Erlotinib as first-line treatment for advanced or recurrent non-small cell lung cancer harboring EGFR exon 21 L858R mutation: A multicenter retrospective observational cohort study in Japan (REAL-SPEED)

Ramucirumab plus Erlotinib as first-line treatment for advanced or recurrent non-small cell lung cancer harboring EGFR exon 21 L858R mutation: A multicenter retrospective observational cohort study in Japan (REAL-SPEED) - Ramucirumab plus Erlotinib as first-line treatment for advanced or recurrent non-small cell lung cancer harboring EGFR exon 21 L858R mutation: A multicenter retrospective observational cohort study in Japan (REAL-SPEED)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000052047
Enrollment
200
Registered
2023-09-01
Start date
2023-09-01
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

Advanced or recurrent non-small cell lung cancer harboring EGFR exon21 L858R mutation

Interventions

None listed

Sponsors

Teikyo University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Non-small cell lung cancer has been diagnosed by either histological diagnosis (excised specimen), biopsies or cellular diagnosis. EGFR ex21 L858R mutation positive based on tissue or plasm specimen Patients with unresectable stage III, stage IV disease according to TNM classification, Version 8, or recurrence after radical treatment by surgery or chemoradiation Performance status (PS): 0-2 Patients who received Ramucirumab + Erlotinib therapy between 1 Nov. 2020 to 31 Aug. 2023

Exclusion criteria

Exclusion criteria: Active double cancers* *Double cancers are synchronous double cancers and metachronous double cancers with a disease-free interval of <3 years, and lesions in carcinoma in situ or mucosal equivalent that are considered cured by local treatment should not be included in active double cancers.

Design outcomes

Primary

MeasureTime frame
Time to treatment failure (TTF)

Secondary

MeasureTime frame
Overall survival (OS Progression-free survival (PFS) Progression-free survival 2 (PFS2) Time to discontinuation of any EGFR-TKI (TD-TKI) Time to failure of strategy (TFS) Objective response rate (ORR) Disease control rate (DCR) Safety

Countries

Japan

Contacts

Public ContactMasashi Ishihara

Department of Internal Medicine, Teikyo University School of Medicine Division of Medical Oncology

m.ishihara@med.teikyo-u.ac.jp03-3964-1211

Outcome results

None listed

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