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A Multicenter, Randomized, Double-Blind Study of Erlotinib in Combination with Ramucirumab or Placebo in Previously Untreated Patients with EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer

A Multicenter, Randomized, Double-Blind Study of Erlotinib in Combination with Ramucirumab or Placebo in Previously Untreated Patients with EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222887
Enrollment
Unknown
Registered
2015-06-16
Start date
2015-06-16
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

Metastatic Non-Small Cell Lung Cancer

Interventions

investigational material(s) Generic name etc : Ramucirumab INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational mater

Sponsors

Eli Lilly Japan K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion Criteria Metastatic NSCLC patients who are eligible for first-line treatment with erlotinib (Part A and Part B) or Gefitinib (Part C) based on previously documented evidence of tumors that have EGFR exon 19 deletions or exon 21(L858R) substitution mutations. ECOG PS of 0 or 1

Exclusion criteria

Exclusion criteria: Exclusion Criteria Patients with known T790M mutation Metastatic brain lesions Ophthalmologic abnormalities Active interstitial lung disease Any prior systemic chemotherapy for advanced or metastatic NSCLC, including prior TKI therapy for any stage.

Outcome results

None listed

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