Phase 2
N=111
A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants
Carcinoma, Non-Small-Cell Lung
Bottom Line
View on ClinicalTrials.gov: NCT01900652 ↗Enrolled (actual)
111
Serious AEs
42.3%
Results posted
Jun 2018
Primary outcome: Primary: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) — 3.0; 4.3; 3.8; 4.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Emibetuzumab (Drug); Erlotinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) |
3.0; 4.3; 3.8; 4.8 | — |
| SECONDARY Progression Free Survival (PFS) |
3.3; 1.6 | — |
| SECONDARY Time to Progressive Disease |
3.8; 1.6 | — |
| SECONDARY Change in Tumor Size (CTS) |
— | — |
| SECONDARY Secondary: Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)] |
50; 26.1; 47.2; 28.6 | — |
| SECONDARY Duration of Response (DoR) |
— | — |
| SECONDARY Overall Survival (OS) |
9.2; 8.2 | — |
| SECONDARY Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30) |
-4.0; -21.9; -10.2; -11.4; -22.9; -19.0 | — |
| SECONDARY Change From Baseline in EORTC Quality of Life Questionnaires Lung Cancer 13 (QLQ-LC13) |
14.1; 16.7; 17.5; 2.6; 0; 3.2 | — |
| SECONDARY Change From Baseline in EuroQol 5-Dimensional Scale (EQ-5D) |
-0.1; -0.2; -0.1; -8.3; -12.5; -11.8 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration (AUC) of Emibetuzumab |
31400 | — |
| SECONDARY Number of Participants With Anti-Emibetuzumab Antibody (ADA) Response |
0; 0 | — |
Summary
The primary purpose of this study is to evaluate the efficacy of the study drug known as LY2875358, administered alone or in combination with a second drug named Erlotinib, in participants affected by a defined type of lung cancer (MET biomarker diagnostic positive Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent treatment with Erlotinib.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of metastatic Stage IV NSCLC
- At least 1 measurable extra-central nervous system (CNS) lesion
- Documented radiographic progression while on continuous treatment with erlotinib monotherapy
- Objective clinical benefit from erlotinib treatment as defined by either documented partial or complete response or stable disease ≥6 months or, if most recent erlotinib treatment has been initiated based on documented epidermal growth factor receptor mutation (EGFRmt) status, at least 12 weeks stable disease
- Determined to be MET diagnostic positive (+)
- Availability of a tumor sample post-erlotinib progression
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Have adequate organ function
Exclusion Criteria
- 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 been treated with LY2875358 or any other MET-targeting experimental therapeutic
- 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 initiation of study treatment therapy
- Pregnant or lactating women
- Have symptomatic CNS metastasis
Data sourced from ClinicalTrials.gov (NCT01900652). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.