A Study of Gemcitabine-Carboplatin Plus Necitumumab (LY3012211) in Chemotherapy-Naïve Participants With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
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| ClinicalTrials.gov Identifier: NCT02941601 |
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Recruitment Status :
Withdrawn
(This was a strategic decision for business planning purposes and not out of concern for patient safety.)
First Posted : October 21, 2016
Last Update Posted : September 27, 2019
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Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
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Brief Summary:
The main purpose of this study is to evaluate the effectiveness and safety of gemcitabine-carboplatin plus necitumumab in chemotherapy-naïve participants with locally advanced or metastatic squamous non-small cell lung cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Locally Advanced Squamous Non-Small Cell Lung Cancer Metastatic Squamous Non-Small Cell Lung Cancer | Drug: Necitumumab Drug: Gemcitabine Drug: Carboplatin | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Phase 2 Study of Gemcitabine-Carboplatin Plus Necitumumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) |
| Study Start Date : | November 2016 |
| Estimated Primary Completion Date : | December 2017 |
| Estimated Study Completion Date : | February 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cohort 1: Necitumumab + Gemcitabine and Carboplatin
Predominately European sites. Gemcitabine administered intravenously (IV) and carboplatin IV plus necitumumab IV.
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Drug: Necitumumab
Administered IV
Other Name: LY3012211 Drug: Gemcitabine Administered IV
Other Name: LY188011 Drug: Carboplatin Administered IV |
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Experimental: Cohort 2: Necitumumab + Gemcitabine and Carboplatin
Predominately United States sites. Gemcitabine administered IV and carboplatin IV plus necitumumab IV.
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Drug: Necitumumab
Administered IV
Other Name: LY3012211 Drug: Gemcitabine Administered IV
Other Name: LY188011 Drug: Carboplatin Administered IV |
Primary Outcome Measures :
- Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response [ Time Frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 18 Months) ]
Secondary Outcome Measures :
- Overall Survival (OS) [ Time Frame: Baseline to Date of Death Due to Any Cause (Approximately 24 Months) ]
- Progression Free Survival (PFS) [ Time Frame: Baseline to Measured Progressive Disease or Death (Approximately 24 Months) ]
- Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, and Stable Disease [ Time Frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 24 Months) ]
- Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab [ Time Frame: Cycle 1 Day 1 through Cycle 6 Day 1 (Approximately 4 Months) ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have confirmed diagnosis of locally advanced or metastatic NSCLC in Cohort 1 and metastatic NSCLC in Cohort 2, predominantly squamous histology. Squamous NSCLC diagnosis must be confirmed by histology or cytology local pathology report.
- Participants in Cohort 1 are required to have epidermal growth factor receptor (EGFR) protein expressing tumor (defined by local immunohistochemistry test). This is not required for participants in Cohort 2.
- Measurable disease at the time of study entry as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
- The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1
- Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy: Biologic agents (for example, antibodies) and Immunotherapy ≥4 weeks; Chest radiotherapy ≥4 weeks; Major surgery, excluding biopsy ≥4 weeks)
- The participant has archived tumor tissue available for biomarker analyses.
- Participants in Cohort 2 are required to have received 1 prior single-agent immune checkpoint inhibitor for squamous NSCLC.
Exclusion Criteria:
- The participant has nonsquamous NSCLC
- The participant has received prior anticancer therapy targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor.
- The participant has received previous chemotherapy (including concurrent chemoradiation) for advanced NSCLC (participants who have received neo-adjuvant and/or adjuvant chemotherapy are eligible if the last administration occurred at least 1 year prior to start of therapy).
- The participant has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants.
- The participant has a bleeding tumor.
- The participant has a history of arterial or venous thromboembolism within 3 months prior to study enrollment.
- The participant has a history or evidence of current clinically-relevant coronary artery disease of current ≥ Class III as defined by Canadian Cardiovascular Society Angina Grading Scale (Campeau 1976) or congestive heart failure of current ≥ Class III as defined by the New York Heart Association.
- The participant has experienced myocardial infarction within 6 months prior to study enrollment.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941601
Locations
| United States, Minnesota | |
| Fairview Southdale Oncology Clinic | |
| Edina, Minnesota, United States, 55435 | |
| Belgium | |
| 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. | |
| Haine-St.- Paul, Belgium, 7100 | |
| 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. | |
| Liege, Belgium, 4000 | |
| 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, Belgium, 8800 | |
| Germany | |
| 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. | |
| Bamberg, Germany, 96049 | |
| 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. | |
| Hannover, Germany, 30459 | |
| 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. | |
| Kassel, Germany, 34125 | |
| Italy | |
| 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. | |
| Avellino, Italy, 50019 | |
| 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. | |
| Messina, Italy, 98122 | |
| 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. | |
| Napoli, Italy, 80131 | |
| 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. | |
| Pisa, Italy, 56125 | |
| Romania | |
| 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. | |
| Baia Mare, Romania, 430291 | |
| 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. | |
| Bucuresti, Romania, 022328 | |
| 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. | |
| Cluj-Napoca, Romania, 400058 | |
| 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. | |
| Craiova, Romania, 200347 | |
| Russian Federation | |
| 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. | |
| Moscow, Russian Federation, 115478 | |
| 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. | |
| St. Petersburg, Russian Federation, 194291 | |
| United Kingdom | |
| 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. | |
| Bebington, United Kingdom, CH63 4JY | |
| 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, United Kingdom, SW3 6JJ | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | 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) | Eli Lilly and Company |
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT02941601 |
| Other Study ID Numbers: |
16535 I4X-MC-JFDA ( Other Identifier: Eli Lilly and Company ) 2016-002041-31 ( EudraCT Number ) |
| First Posted: | October 21, 2016 Key Record Dates |
| Last Update Posted: | September 27, 2019 |
| Last Verified: | September 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Eli Lilly and Company:
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Thoracic Neoplasms Lung Diseases Lung Cancer Respiratory Tract Diseases |
Respiratory Tract Neoplasms Antineoplastic Agents Monoclonal Antibodies |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Gemcitabine Carboplatin |
Necitumumab Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Immunological |