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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)
Study Start Date :	June 2015
Actual Primary Completion Date :	June 23, 2017
Estimated Study Completion Date :	November 12, 2018

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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) 

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
Last Update Posted:	July 13, 2017
Last Verified:	July 2017

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