I4C-MC-JTBB: A Randomized, Controlled Phase 2 Study Evaluating LY2875358 plus Erlotinib versus Erlotinib as First-Line Treatment in Metastatic NSLC Patients with Activating EGFR Mutations Who Have Disease Control after an 8-Week Lead-In Treatment with Erlotinib

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514268-18-00

Acronym

I4C-MC-JTBB

Enrollment

Registered

2024-11-04

Start date

2013-09-06

Completion date

2026-01-08

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Brief summary

The primary endpoint of the study is progression-free survival (PFS). PFS is defined as the time from the date of study randomization to the date of first observation of objective radiographic progression or death from any cause as defined by RECIST 1.1 (Eisenhauer et al. 2009). If a patient is event-free at analysis, the patient will be censored at the last progression-free tumor assessment.

Interventions

DRUGLY2875358

DRUGERLOTINIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is progression-free survival (PFS). PFS is defined as the time from the date of study randomization to the date of first observation of objective radiographic progression or death from any cause as defined by RECIST 1.1 (Eisenhauer et al. 2009). If a patient is event-free at analysis, the patient will be censored at the last progression-free tumor assessment.	—

Countries

Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026