ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of the Combination of Necitumumab (LY3012211) and Pembrolizumab (MK3475) in Participants With NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02451930
Recruitment Status : Active, not recruiting
First Posted : May 22, 2015
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to evaluate the safety and efficacy of the combination of necitumumab with pembrolizumab in participants with stage IV non-small cell lung cancer (NSCLC).

Condition or disease Intervention/treatment Phase
Stage IV Non-Small Cell Lung Cancer Drug: Necitumumab Drug: Pembrolizumab Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Phase 1b Study With an Expansion Cohort to Evaluate Safety and Efficacy of the Combination of Necitumumab With Pembrolizumab in Patients With Stage IV Non-Small Cell Lung Cancer
Study Start Date : September 2015
Actual Primary Completion Date : January 26, 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Necitumumab + Pembrolizumab

(Part A) Escalating doses of necitumumab administered intravenously (IV) on day 1 and day 8 every 3 weeks (Q3W) in combination with pembrolizumab IV on day 1 Q3W. Treatment may continue until discontinuation criterion is met.

(Part B) Necitumumab dose identified in part A administered IV on day 1 and day 8 Q3W in combination with pembrolizumab IV on day 1 Q3W. Treatment may continue until discontinuation criterion is met.

(Part C) Confirmation of necitumumab dose identified in part A administered IV on day 1 and day 8 Q3W in combination with pembrolizumab IV on day 1 Q3W in Japanese participants. Treatment may continue until discontinuation criterion is met.

Drug: Necitumumab
Administered IV
Other Name: LY3012211

Drug: Pembrolizumab
Administered IV
Other Name: MK3475




Primary Outcome Measures :
  1. Number of Participants with Dose Limiting Toxicities (DLTs) in Part A and C [ Time Frame: Baseline through Cycle 1 (21 day cycles) ]
  2. Objective Response Rate (ORR) in Part B: Proportion of Participants With a Complete or Partial Response [ Time Frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 15 Months) ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) in Part A and C: Proportion of Participants With a Complete or Partial Response [ Time Frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 15 Months) ]
  2. Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab [ Time Frame: Predose Cycle 1 Day 1 through Predose Cycle 8 Day 1 (21 Day Cycles) ]
  3. Number of Participants with Anti-Necitumumab Antibodies [ Time Frame: Predose Cycle 1 Day 1 through Predose Cycle 8 Day 1 (21 Day Cycles) ]
  4. Disease Control Rate (DCR) in Part B: 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 (Approximately 15 Months) ]
  5. Duration of Response (DoR) in Part B [ Time Frame: Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Approximately 15 Months) ]
  6. Progression Free Survival (PFS) in Part B [ Time Frame: Baseline to Measured Progressive Disease or Death Due to Any Cause (Approximately 15 Months) ]
  7. Overall Survival (OS) in Part B [ Time Frame: Baseline to Death from Any Cause (Approximately 15 Months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The participant has Stage IV NSCLC.

    • Part A: NSCLC Stage IV (any type)
    • Part B: NSCLC Stage IV (squamous and nonsquamous)
    • Part C: NSCLC Stage IV in Japanese participants (squamous and nonsquamous)
  • The participant must have progressed after 1 platinum-based chemotherapy regimen for Stage IV NSCLC. Prior therapy with VEGF/VEGFR targeting agents is permitted. Prior neoadjuvant/adjuvant therapy is permitted. Prior treatment with EGFR-TKI and ALK inhibitors is mandatory in participants with NSCLC whose tumor has EGFR-activating mutations or ALK translocations, respectively.
  • 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 evaluable tumor tissue available for biomarker analyses.
  • The participant has adequate organ function.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1.

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 an anti-PD-1, anti-PD-L1, anti-PD-L2 monoclonal antibody.
  • Have a serious concomitant systemic disorder or significant cardiac disease.
  • The participant has undergone major surgery or received anti-cancer monoclonal antibody therapy in the 30-days prior to study enrollment.
  • The participant has undergone chest irradiation within 2 weeks prior to receiving study treatment.
  • The participant has brain metastases that are symptomatic.
  • The participant has a history of arterial thromboembolism event (ATE) or venous thromboembolism event (VTE) within 3 months prior to study enrollment. Participants with history of VTE beyond 3 months prior to study enrollment can be enrolled if they are appropriately treated with low molecular weight heparin.
  • 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 pembrolizumab, or any other contraindication to one of the administered treatments.
  • 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, pneumonitis, autoimmune disease or syndrome that requires steroids or immunosuppressive agents.
  • The participant has active infection requiring systemic therapy, including active tuberculosis or known history of infection with the human immunodeficiency virus (HIV 1/2 antibodies), or hepatitis B (e.g., HBsAg reactive) and/or C virus (e.g., HCV RNA [qualitative] is detected).
  • The participant has an active autoimmune disease or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
  • The participant has received a live vaccine within 30 days prior to the first dose of trial treatment.

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): NCT02451930


Locations
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
Florida Cancer Specialists
Saint Petersburg, Florida, United States, 33705
United States, Tennessee
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
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.
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 Cedex 08, 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.
Paris, France, 75015
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.
Saint Herblain Cedex, France, 44805
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 Cedex, France, 94805
Japan
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
Chuo-Ku, Japan, 104-0045
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
Sunto-Gun, Japan, 411-8777
Spain
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.
Badajoz, Spain, 06080
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.
Barcelona, Spain, 08907
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, 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.
Valencia, Spain, 46026
Sponsors and Collaborators
Eli Lilly and Company
Merck Sharp & Dohme Corp.
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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02451930     History of Changes
Other Study ID Numbers: 15568
I4X-MC-JFCQ ( Other Identifier: Eli Lilly and Company )
2015‐001291‐22 ( EudraCT Number )
KEYNOTE -099 ( Other Identifier: Merck )
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
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
Pembrolizumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs