West Cancer Center

MOLECULARLY TARGETED: EGFR mut: Metastatic; >/= 2nd line; \"My Pathway- EGFR\"

My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib/cobimetinib, vismodegib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents

Title

Genentech ML28897 EGFR

Study Title

Site Link

NCT02091141

Malignancy

y- Peritoneum, Prostate, CNS (brain), stomach (gastric), ovarian, adrenal, biliary tract (bile duct), salivary gland, thyroid, kidney (RCC), urinary tract (bladder), Head and neck (SCCHN), esophagus

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

Investigational Agent

erlotinib

Drug Class

EGFR inhibitor

VanderWalde

Sponsor

Genentech, Inc.

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Metastatic cancer
EFGR activatingmutation (not exon 20)
NSCLC or pancreatic must not haveexon 19 deletions or exon 21 L858R substitution2nd line or greater
ECOG PS 0-2
No prior treatment with any EGFR inhibitor
No active or untreated CNS metastastasis

Objective

Primary- ORR; Secondary- DCR, PFS, 1-year OS

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

EGFR activating mutation (not exon 20)

Dosing Frequency

erlotinib 150mg PO daily

Control Agents

None

Study Protocol

Randomized