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A Study of Necitumumab and Abemaciclib in Participants With Non-Small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT02411591
Recruitment Status : Active, not recruiting
First Posted : April 8, 2015
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
This is medical research evaluating the safety and efficacy of two new medicines (necitumumab and abemaciclib), administered in combination in participants affected by a defined type of advanced lung cancer (stage IV non-small-cell lung cancer).

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Neoplasm Metastasis Drug: Necitumumab Drug: Abemaciclib Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Arm, Multicenter, Phase 1b Study With an Expansion Cohort to Evaluate Safety and Efficacy of Necitumumab in Combination With Abemaciclib in Treatment of Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)
Actual Study Start Date : June 4, 2015
Actual Primary Completion Date : June 23, 2017
Estimated Study Completion Date : November 12, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Necitumumab + Abemaciclib

Part A: Necitumumab administered intravenously (IV) on Days 1 and 8, followed by abemaciclib given orally Q12H on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met.

Part B: Necitumumab administered IV on Days 1 and 8, followed by abemaciclib given orally Q12H on Days 1 to 21. (21 day cycles.) Abemaciclib dose determined by Part A. Treatment may continue until discontinuation criterion is met.

 Drug: Necitumumab
Administered IV.
Other Name: LY3012211

Drug: Abemaciclib
Administered orally.
Other Name: LY2835219


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Abemaciclib Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 1 in Part A (21 day cycles) ]
  2. Progression Free Survival (PFS) Rate at Three Months [ Time Frame: Baseline to measured progressive disease or death due to any cause in Part B at three months ]

Secondary Outcome Measures :
  1. Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR]) [ Time Frame: Baseline to measured progressive disease or start of new anti-cancer therapy (up to 21 months) ]
  2. Pharmacokinetics (PK): Predose Concentration (Cmin) of Necitumumab and Abemaciclib [ Time Frame: Cycle 1 up to Cycle 7 (21 day cycles) ]
  3. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab and Abemaciclib [ Time Frame: Cycle 1 up to Cycle 7 (21 day cycles) ]
  4. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Abemaciclib [ Time Frame: Cycle 1 up to Cycle 2 (21 day cycles) ]
  5. Disease Control Rate (DCR): Defined as Proportion of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) [ Time Frame: Baseline to measured progressive disease or start of new anti-cancer therapy (up to 21 months) ]
  6. Overall Survival [ Time Frame: Baseline to date of death from any cause (up to 21 months) ]

Eligibility Criteria
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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:

  • Histologically or cytologically confirmed NSCLC Stage IV:

    • Part A: NSCLC Stage IV (any type).
    • Part B: NSCLC Stage IV (squamous and nonsquamous).
  • 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 must have progressed after platinum-based chemotherapy AND have received a maximum of 1 other prior chemotherapy for advanced and/or metastatic disease OR must be judged by the physician as ineligible for further standard second-line chemotherapy. Prior treatment with epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) and anaplastic lymphoma kinase (ALK) inhibitors is mandatory in participants whose tumor has EGFR-activating mutations or ALK translocations. Prior targeting agents and neoadjuvant/adjuvant therapies are permitted with the exception of cyclin-dependent kinase (CDK)4/6-targeting agents or necitumumab.
  • The participant has tumor tissue available for biomarker analyses.
  • The participant has an Eastern Cooperative Oncology Group performance status score of 0-1.
  • Have adequate organ functions.

Exclusion Criteria:

  • The participant is currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device. Prior treatment with CDK4/6-targeting agents or necitumumab is not permitted.
  • Have a serious concomitant systemic disorder or significant cardiac disease.
  • The participant has undergone major surgery or received any investigational therapy in the 30-days prior to study enrollment.
  • The participant has undergone chest irradiation within 4 weeks prior to receiving study treatment.
  • The participant has brain metastases that are symptomatic.
  • History of arterial or venous thromboembolism within 3 months prior to study enrollment. Participants with a history of venous thromboembolism beyond 3 months prior to study enrollment can be enrolled if they are appropriately treated with low molecular weight heparin.
  • The participant has active infection requiring systemic therapy.
  • The participant has a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab or abemaciclib, or any other contraindication to one of the administered treatments.
  • The participant is pregnant or breastfeeding.
  • The participant has a concurrent active malignancy. Previous history of malignancy is permitted, provided that the participant has been free of disease for ≥3 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, preinvasive carcinoma of the cervix, or any cancers that in the judgment of the investigator and sponsor may not affect the interpretation of results (for example, prostate, bladder).
  • History of interstitial lung disease or an active non-infectious pneumonitis.
Contacts and Locations
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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): NCT02411591


Locations
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.
Charleroi, Belgium, 6000
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.
Leuven, Belgium, 3000
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
France
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.
Brest, France, 29609
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.
Bron, France, 69677
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.
Lille, France, 59037
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.
Lyon, France, 69373
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.
Marseille Cedex 05, France, 13385
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, France, 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.
Pau, France, 64046
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.
Strasbourg Cedex, France, 67091
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.
Villejuif, France, 94805
Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
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.
Madrid, Spain, 28040
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.
Sevilla, Spain, 46014
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
More Information
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Additional Information:
Click here for more information about this study: A Study of Necitumumab (LY3012211) and Abemaciclib (LY2835219) in Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)  This link exits the ClinicalTrials.gov site

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02411591     History of Changes
Other Study ID Numbers: 15573
I4X-MC-JFCU ( Other Identifier: Eli Lilly and Company )
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: October 1, 2018

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs