West Cancer Center

LUNG: Metastatic; NSCLC; EGFR mutant; cMET positive; 2nd line; "I4C-MC-JTBC"

A randomized, open-label phase 2 study evaluating LY2875358 plus erlotinib and LY2875358 monotherapy in MET diagnostic positive NSCLC patients with acquired resistance to erlotinib

Title

Eli Lilly I4C-MC-JTBC

Study Title

A randomized, open-label phase 2 study evaluating LY2875358 plus erlotinib and LY2875358 monotherapy in MET diagnostic positive NSCLC patients with acquired resistance to erlotinib

Site Link

NCT01900652

Malignancy

Lung, NSCLC, Non-small cell lung cancer

Stage

Stage 3

Disease Setting

Metastatic/Palliative

Line Of Therapy

>=2nd

Investigational Agent

LY2875358

Drug Class

cMET antibody

Kurt Tauer, MD

Sponsor

Eli Lilly and Company

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT01900652?term=I4C-MC-JTBC&rank=1

Key Eligibility Criteria Details

Documented PD while on erlotinib monotherapy
Determined to be MET diagnostic positive
Availability of post-erlotinib tumor sample
ECOG 0-2
No symptomatic CNS disease
No interstitial pneumonia or fibrosis
No need for fluid drainage >1x/wk (Pl eff, ascites, etc.)

Objective

Primary- ORR: Secondary- PFS, TTPD, change in tumor size, DCR, OS, QOL, PK, antibody development against drug

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

EGFR mutation cMET mutation

Dosing Frequency

LY2875358 750mg IV day 1, 15 of 28 day cycle +/- erlotinib daily

Control Agents

N/A

Study Protocol

Randomized

Yes