Clinical trial · Interventional
A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Emibetuzumab | Drug | — | UNRESOLVED |
| Erlotinib | Drug | Erlotinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Emibetuzumab plus Erlotinib
- description
- 750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
- interventionNames
- Drug: Emibetuzumab
- Drug: Erlotinib
- type
- EXPERIMENTAL
- label
- Arm B: Emibetuzumab
- description
- 750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
- interventionNames
- Drug: Emibetuzumab
Primary outcomes (1)
- measure
- Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available