Carcinoma, Non-Small-Cell LungPhase 2ChimeNCT01900652
A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants
A Phase 2 study testing Emibetuzumab and Erlotinib in people with Carcinoma, Non-Small-Cell Lung, run by Eli Lilly and Company at 59 sites in 10 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Emibetuzumab and Erlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 59 sitesin 10 countries
- Study dates
- Aug 2013to Mar 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
59 sites in 10 countries.
59 sites in 10 countries
United States32 sites
Northeast Georgia Cancer Care, LLC
Athens, Georgia, 30607
Emory University
Atlanta, Georgia, 30322
University of Colorado Health Sciences Center
Aurora, Colorado, 80045
Billings Clinic Research Center
Billings, Montana, 59101
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Carolinas Medical Center
Charlotte, North Carolina, 28204
Tennessee Oncology PLLC
Chattanooga, Tennessee, 37404
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242
Karmanos Cancer Institute
Detroit, Michigan, 48201
Florida Cancer Specialists
Fort Myers, Florida, 33916-2233
University of Iowa Hospital
Iowa City, Iowa, 52242
MS Center at Evergreen
Kirkland, Washington, 98034
University of California - San Diego
La Jolla, California, 92037
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Los Angeles, California, 90048
The West Clinic
Memphis, Tennessee, 38120
Tennessee Oncology PLLC
Nashville, Tennessee, 37203
Columbia University
New York, New York, 10032
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Portland VA Medical Center
Portland, Oregon, 97213
Mayo Clinic
Rochester, Minnesota, 55905
University of California, Davis - Health Systems
Sacramento, California, 95817
UCLA
Santa Monica, California, 90404
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Group Health
Seattle, Washington, 98112
Washington University Medical Center
St Louis, Missouri, 63110
Florida Cancer Specialists
St. Petersburg, Florida, 33705
Multicare Health System
Tacoma, Washington, 98405
H Lee Moffitt Cancer Center
Tampa, Florida, 33612
Georgetown University Medical Center IRB
Washington D.C., District of Columbia, 20007
University of Kansas Medical Center
Westwood, Kansas, 66205
Israel6 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Beersheba, 84101
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Jerusalem, 91120
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kfar Saba, 44281
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Petah Tikva, 49100
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tel HaShomer, 52621
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tsrifin, 6093000
United Kingdom5 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bristol, Avon, BS10 5NB
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Headington, Oxford, OX3 7LE
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
London, Greater London, W6 8RF
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Southampton, Hants, SO16 6YD
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wythenshawe, Manchester, M23 9LT
Belgium4 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aalst, 9300
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ghent, 9000
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mechelen, 2800
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Roeselare, 8800
Spain3 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Badalona, 08916
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pamplona, 31008
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Valencia, 46026
France2 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Montpellier, 34295
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Toulouse, 31059
Germany2 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Heidelberg, 69126
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ulm, 89081
Italy2 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Milan, 20052
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Orbassano, 10043
Netherlands2 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Amsterdam, 1081 HV
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Breda, 4818 CK
South Korea1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seoul, 138-736
About this study
Official 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
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
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Emibetuzumab, Erlotinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmibetuzumabDrug
Also called LY2875358
Administered IV
ErlotinibDrug
Administered Orally
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Emibetuzumab plus Erlotinib | Experimental | 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. Receives: Drug: Emibetuzumab; Drug: Erlotinib |
| Arm B: Emibetuzumab | Experimental | 750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle. Receives: Drug: Emibetuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.
Measured: Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Up to 15 Months)
Secondary outcomes (11)
Progression Free Survival (PFS)
PFS defined as date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors criteria or death from any cause, whichever is first.
Progressive disease (PD) defined as ≥20% increase in sum of diameter of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non- target lesions. Participants with no baseline disease assessment were censored at randomization date, regardless of whether or not objectively determined PD or death was observed; participants not known to have died or to have objective progression as of data inclusion cutoff were censored at last post baseline radiological assessment date or randomization date, if there was no post baseline radiological assessment.
Measured: Baseline to Objective Disease Progression or Death (Up to 24 Months)
Time to Progressive Disease
Measured: Baseline to Objective Disease Progression (Up to 24 Months)
Change in Tumor Size (CTS)
Zero participants analyzed. CTS data was not collected for analysis due to N=0 CR and N=3 PR.
Measured: Baseline to Measurement with Smallest Tumor Size (Up to 24 Months)
Secondary: Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)]
Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control equals (number of participants with CR, PR, or SD)/(number of participants assessed)*100.
Measured: Baseline to Objective Disease Progression or Participant Stops Study (Up to 24 Months)
Duration of Response (DoR)
Zero participants analyzed. Duration of Response for CR and PR data was not collected for analysis due to N=0 CR and N=3 PR.
Measured: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months)
Overall Survival (OS)
OS was defined as duration from the date of study enrollment to the date of death from any cause. Participants not known to have died as of the data inclusion cut-off date were censored at the date of last contact. The last contact for participants in post-discontinuation was the last date participant was known to be alive.
Measured: Baseline to Death Due to Any Cause (Up to 24 Months)
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.
Measured: Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
Change From Baseline in EORTC Quality of Life Questionnaires Lung Cancer 13 (QLQ-LC13)
The EORTC lung module QLQ-LC13 comprises 13 items consisting of one multi-item scale to assess dyspnea and a series of single-item measures assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. The higher scores represent a greater degree of symptoms.
Measured: Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
Change From Baseline in EuroQol 5-Dimensional Scale (EQ-5D)
The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.
Additionally, participants will indicate their current health status by marking on a continuum ranging from 100 (best imaginable health state) to 0 (worst imaginable health state).
Measured: Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
Pharmacokinetics (PK): Area Under the Concentration (AUC) of Emibetuzumab
AUC(0-tlast) = area under the concentration versus time curve from time zero through the last quantifiable sample.
Measured: Cycle1 Day 1 (C1 D1): Pre-dose and End of infusion; C1 D8: Pre-dose; C1 D15, C2 D1, C2 D15, C3 D1, C3 D15, C4 D1, C4 D15: Pre-dose and End of Infusion
Number of Participants With Anti-Emibetuzumab Antibody (ADA) Response
Measured: Baseline through 30-Day Follow-Up (Up to 24 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900652
- Sponsor's protocol ID
- 14208
- Other IDs
- I4C-MC-JTBC
- Acronym
- Chime
- Status last verified
- Sep 2019
- First submitted
- 12 Jul 2013
- Last updated
- 18 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01900652
- Acronym / sponsor ID
- Chime / 14208
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 16 Jul 2013 (estimated)
- Results
- Posted 25 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Emibetuzumab plus Erlotinib | Experimental | Drug: Emibetuzumab, Drug: Erlotinib750 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. |
| Arm B: Emibetuzumab | Experimental | Drug: Emibetuzumab750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 (+)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmibetuzumabAlso: LY2875358Administered IV | Drug | Arm A: Emibetuzumab plus Erlotinib, Arm B: Emibetuzumab |
| ErlotinibAdministered Orally | Drug | Arm A: Emibetuzumab plus Erlotinib |
Primary outcome
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Time frame: Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Up to 15 Months)
ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.
11 secondary outcomes
Progression Free Survival (PFS)
Time frame: Baseline to Objective Disease Progression or Death (Up to 24 Months)
Time to Progressive Disease
Time frame: Baseline to Objective Disease Progression (Up to 24 Months)
Change in Tumor Size (CTS)
Time frame: Baseline to Measurement with Smallest Tumor Size (Up to 24 Months)
Secondary: Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)]
Time frame: Baseline to Objective Disease Progression or Participant Stops Study (Up to 24 Months)
Duration of Response (DoR)
Time frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months)
Overall Survival (OS)
Time frame: Baseline to Death Due to Any Cause (Up to 24 Months)
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)
Time frame: Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
Change From Baseline in EORTC Quality of Life Questionnaires Lung Cancer 13 (QLQ-LC13)
Time frame: Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
Change From Baseline in EuroQol 5-Dimensional Scale (EQ-5D)
Time frame: Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)
Pharmacokinetics (PK): Area Under the Concentration (AUC) of Emibetuzumab
Time frame: Cycle1 Day 1 (C1 D1): Pre-dose and End of infusion; C1 D8: Pre-dose; C1 D15, C2 D1, C2 D15, C3 D1, C3 D15, C4 D1, C4 D15: Pre-dose and End of Infusion
Number of Participants With Anti-Emibetuzumab Antibody (ADA) Response
Time frame: Baseline through 30-Day Follow-Up (Up to 24 Months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Related trials for Carcinoma, Non-Small-Cell Lung
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
59 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Emibetuzumab and Erlotinib in people with Carcinoma, Non-Small-Cell Lung, run by Eli Lilly and Company at 59 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, Israel, United Kingdom, Belgium, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) (time frame: Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Up to 15 Months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.