OncRef

Clinical Trial: NCT01897480

A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:Eli Lilly and Company
Information Provided By:Eli Lilly and Company
Last Update Posted:2026-01-26

Study Overview

Brief Summary

The primary purpose of this study is to compare the efficacy of the study drug LY2875358, given together with erlotinib, against erlotinib, alone. Participants will have Non-Small Cell Lung Cancer (NSCLC) that has advanced to Stage IV. Participants should not have been treated with drugs for Stage IV NSCLC, previously. All participants will get erlotinib alone, for approximately 8 weeks. Participants with radiographic disease control at the end of the erlotinib lead-in study period will be randomly assigned to receive LY2875358 plus erlotinib or erlotinib alone. Participants, who were chosen to receive erlotinib, alone, may cross over to the combination treatment at the time of progression.

Official Title

A Randomized, Controlled Phase 2 Study Evaluating LY2875358 Plus Erlotinib Versus Erlotinib as First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations Who Have Disease Control After an 8-Week Lead-In Treatment With Erlotinib

Conditions

Carcinoma, Non-Small-Cell Lung

Intervention / Treatment

  • Biological: LY2875358
  • Drug: Erlotinib

Other Study ID Numbers

  • 14209
  • I4C-MC-JTBB
  • 2024-514268-18-00

Start Date (Actual)

2013-08-28

Primary Completion Date (Actual)

2016-03-14

Study Completion Date (Actual)

2026-01-08

Enrollment (Actual)

168

Study Type

Interventional

Phase

Phase 2