A Study of Necitumumab in the First-Line Treatment of Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01763788
First received: January 7, 2013
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

The purpose of the Phase 1b portion of the study is to investigate how the body tolerates necitumumab, in combination with gemcitabine and cisplatin chemotherapy as first line treatment in participants with Stage IV squamous NSCLC and to determine the recommended dose for the subsequent Phase 2 portion of the study.

The purpose of the Phase 2 portion of the study is to evaluate the efficacy of necitumumab in combination with gemcitabine and cisplatin chemotherapy in participants with Stage IV squamous NSCLC in a first-line setting.


Condition Intervention Phase
Squamous Non-small Cell Lung Cancer
Drug: Necitumumab
Drug: Gemcitabine
Drug: Cisplatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Phase 1b/2 Study to Evaluate Necitumumab in Combination With Gemcitabine and Cisplatin in the First-Line Treatment of Patients With Advanced (Stage IV) Squamous Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Phase 1b: Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Day 1 to Day 21 in Cycle 1 (estimated up to 21 days) ] [ Designated as safety issue: Yes ]
  • Phase 2: Overall Survival (OS) [ Time Frame: Baseline to Death from Any Cause (estimated up to 39 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phase 2: Progression Free Survival (PFS) [ Time Frame: Baseline to Measured Progressive Disease or Death from Any Cause (estimated up to 39 months) ] [ Designated as safety issue: No ]
  • Phase 1b: Number of Participants who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR]) [ Time Frame: Baseline to Measured Progressive Disease (estimated up to 39 months) ] [ Designated as safety issue: No ]
  • Phase 2: Number of Participants who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR]) [ Time Frame: Baseline to Measured Progressive Disease (estimated up to 39 months) ] [ Designated as safety issue: No ]
  • Phase 2: Time to Treatment Failure (TTF) [ Time Frame: Baseline to Measured Progressive Disease or Death from Disease Any Cause (estimated up to 39 months) ] [ Designated as safety issue: No ]
  • Phase 2: Change from Baseline in EuroQol 5-Dimensional Scale (EQ-5D) [ Time Frame: Baseline to Measured Progressive Disease (estimated up to 39 months) ] [ Designated as safety issue: No ]
  • Phase 2: Change from Baseline in Lung Cancer Symptom Scale (LCSS) [ Time Frame: Baseline to Measured Progressive Disease or Participant Stops Study (estimated up to 39 months) ] [ Designated as safety issue: No ]
  • Phase 1b/2: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab [ Time Frame: Baseline up to Cycle 4 (estimated up to 3 months) ] [ Designated as safety issue: No ]
  • Phase 1b: PK: Cmax of Gemcitabine and Cisplatin [ Time Frame: Baseline up to Cycle 1 (estimated up to 1 Month) ] [ Designated as safety issue: No ]
  • Phase 1b: PK: Area Under the Concentration Curve (AUC) of Necitumumab [ Time Frame: Baseline up to Cycle 4 (estimated up to 3 months) ] [ Designated as safety issue: No ]
  • Phase 1b: PK: AUC of Gemcitabine and Cisplatin [ Time Frame: Baseline up to Cycle 4 (estimated up to 3 months) ] [ Designated as safety issue: No ]
  • Phase 2: PK: Minimum Concentration (Ctrough) of Necitumumab [ Time Frame: Baseline up to Cycle 4 (estimated up to 3 months) ] [ Designated as safety issue: No ]
  • Number of Participants with Anti Necitumumab Antibodies [ Time Frame: Baseline up to 30 Days Post Last Infusion (estimated up to 39 months) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 189
Study Start Date: May 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Necitumumab + Gem and Cis

Phase 1b Dose Escalation: Necitumumab 800 milligram (mg) on Days 1 and 8 of every 21 day cycle, administered as an intravenous (IV) infusion. Gemcitabine (Gem) dose escalation of 1000 or 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of every 21 day cycle, administered as an IV infusion for a maximum of 4 cycles. Cisplatin (Cis) 75 mg/m^2 on Day 1 of every 21 day cycle, administered as an IV infusion for a maximum of 4 cycles.

Phase 2 Randomized: Necitumumab 800 mg on Days 1 and 8 of every 21 day cycle, administered as an IV infusion. Gemcitabine at fixed dose determined in Phase 1b (1000 or 1250 mg/m^2) on Days 1 and 8 of every 21 day cycle, administered as an IV infusion for a maximum of 4 cycles. Cisplatin 75 mg/m^2 on Day 1 of every 21 day cycle, administered as an IV infusion for a maximum of 4 cycles.

Drug: Necitumumab
Administered IV
Other Names:
  • IMC-11F8
  • LY3012211
Drug: Gemcitabine
Administered IV
Other Name: LY188011
Drug: Cisplatin
Administered IV
Active Comparator: Gemcitabine + Cisplatin
Phase 2 Randomized: Gemcitabine at fixed dose determined in Phase 1b (1000 to 1250 mg/m^2) on Day 1 and Day 8 of every 21 day cycle,administered as an IV infusion over approximately 30 minutes for a maximum of 4 cycles. Cisplatin 75 mg/m^2 on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 120 minutes for a maximum of 4 cycles .
Drug: Gemcitabine
Administered IV
Other Name: LY188011
Drug: Cisplatin
Administered IV

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Squamous Non-Small Cell Lung Cancer Disease
  • Clinical Stage IV
  • Measurable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
  • No prior chemotherapy regimen, surgery and chest radiotherapy
  • Adequate organ function
  • Estimated life expectancy of at least 12 weeks

Exclusion Criteria:

  • Has undergone major surgery within 28 days prior to enrollment or have planned major surgery, subcutaneous venous access device placement within 7 days prior to enrollment
  • Has undergone any prior radiation therapy, except for Gamma Knife radiation and palliative radiation treatment at least 14 days have elapsed from last radiation treatment prior to enrollment
  • Has brain metastases that are symptomatic or require surgery, medication and radiotherapy except Gamma Knife
  • Has superior vena cava syndrome
  • Has clinically relevant coronary artery disease or uncontrolled congestive - heart failure
  • Has uncontrolled hypertension
  • Has diabetes requiring insulin
  • Has an angina or has experienced myocardial infarction within 6 months prior to enrollment
  • Has an Acquired Immunodeficiency Syndrome (AIDS)-related illness
  • Has evidence of or test positive test results for hepatitis B, or hepatitis C virus antibodies
  • Has a known allergy and history of hypersensitivity reaction
  • Has significant third-space fluid retention
  • Has history of interstitial pneumonitis
  • Has an ongoing or active infection
  • Has a history of significant neurological or psychiatric disorders
  • Has a Grade 2 peripheral neuropathy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763788

Contacts
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Locations
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. Recruiting
Aichi, Japan, 464-8681
Contact: Eli Lilly         
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. Recruiting
Chiba, Japan, 277 8577
Contact: Eli Lilly         
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. Recruiting
Ehime, Japan, 791-0280
Contact: Eli Lilly         
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. Recruiting
Fukuoka, Japan, 830-0011
Contact: Eli Lilly         
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. Recruiting
Hokkaido, Japan, 070-8644
Contact: Eli Lilly         
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. Recruiting
Hyogo, Japan, 650-0047
Contact: Eli Lilly         
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. Recruiting
Ishikawa, Japan, 920-8641
Contact: Eli Lilly         
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. Recruiting
Kanagawa, Japan, 240-0062
Contact: Eli Lilly         
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. Recruiting
Miyagi, Japan, 980-8574
Contact: Eli Lilly         
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. Recruiting
Nagasaki, Japan, 852-8501
Contact: Eli Lilly         
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. Recruiting
Niigata, Japan, 951-8566
Contact: Eli Lilly         
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. Recruiting
Oita, Japan, 8795593
Contact: Eli Lilly         
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. Recruiting
Okayama, Japan, 700-8558
Contact: Eli Lilly         
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. Recruiting
Osaka, Japan, 573-1191
Contact: Eli Lilly         
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. Recruiting
Saitama, Japan, 362-0806
Contact: Eli Lilly         
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. Recruiting
Shizuoka, Japan, 411-8777
Contact: Eli Lilly         
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. Recruiting
Tokyo, Japan, 135-8550
Contact: Eli Lilly         
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. Recruiting
Wakayama, Japan, 641-8510
Contact: Eli Lilly         
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. Recruiting
Yamaguchi, Japan, 755-0241
Contact: Eli Lilly         
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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01763788     History of Changes
Other Study ID Numbers: 14461, I4X-JE-JFCM
Study First Received: January 7, 2013
Last Updated: July 18, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Cisplatin
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014