Status:
ACTIVE_NOT_RECRUITING
A Study of LY2875358 in Participants With Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations
Lead Sponsor:
Eli Lilly and Company
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 (NS...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed diagnosis of metastatic Stage IV NSCLC
- Have at least 1 measurable lesion whose presence is assessable using standard techniques by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
- Have molecular evidence of an epidermal growth factor receptor mutation (EGFRmt) known to be associated with EGFR tyrosine kinase inhibitor (TKI) drug sensitivity (G719X, exon 19 deletion, L858R, L861Q)
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Haven't received any prior systemic chemotherapy for Stage IV NSCLC (unless received as neoadjuvant or adjuvant therapy for early-stage NSCLC disease and completed therapy at least 6 months prior to enrollment)
- Availability of adequate tumor material (block or slides)
Exclusion
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device
- Have previously completed or withdrawn from this study or any other study investigating LY2875358
- Have a serious concomitant systemic disorder or significant cardiac disease
- Have interstitial pneumonia or interstitial fibrosis of the lung or have pleural effusion, pericardial fluids or ascites, requiring drainage every other week or more frequently
- Have a history of another malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to the study
- Have major surgery less than 2 weeks prior to the initiation of study treatment therapy
- Pregnant or lactating women
Key Trial Info
Start Date :
August 28 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01897480
Start Date
August 28 2013
End Date
December 1 2025
Last Update
April 20 2025
Active Locations (45)
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1
Herlev and Gentofte Hospital
Herlev, Capital Region, Denmark, 2730
2
Rigshospitalet
Copenhagen, Copenhagen, Denmark, 2100
3
Odense Universitetshospital
Odense C, Syd, Denmark, 5000
4
CHU de Caen Hopital Cote de Nacre
Caen, France, 14033