A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01769391
First received: January 14, 2013
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy of paclitaxel and carboplatin is more effective to treat cancer than the standard chemotherapy of paclitaxel and carboplatin alone.


Condition Intervention Phase
Squamous Non Small Cell Lung Cancer
Drug: Necitumumab
Drug: Paclitaxel
Drug: Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Open-Label, Phase 2 Study of Paclitaxel-Carboplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Paclitaxel-Carboplatin Chemotherapy Alone in the First-Line Treatment of Patients With 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:
  • Percentage of Participants who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR]) [ Time Frame: Baseline to Disease Progression or Death (Estimated up to 24 Months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Baseline to Date of Death (Estimated up to 27 Months) ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab [ Time Frame: Predose to End of Cycle 6 (Estimated up to 5 Months) ] [ Designated as safety issue: No ]
  • Percentage of Participants with Anti Necitumumab Antibodies [ Time Frame: Baseline to End of Cycle 6 (Estimated up to 5 Months) ] [ Designated as safety issue: Yes ]
  • Progression-Free Survival [ Time Frame: Baseline to Progressive Disease or Death (Estimated up to 24 Months) ] [ Designated as safety issue: No ]
  • Percentage of Participants who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR]) [ Time Frame: Baseline to Progressive Disease and/or Death (Estimated up to 24 Months) ] [ Designated as safety issue: No ]
  • Percent Change in Tumor Size (CTS) [ Time Frame: Baseline to Progressive Disease or Death (Estimated up to 24Months) ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab [ Time Frame: Predose to End of Cycle 6 (Estimated up to 5 Months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 162
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Necitumumab +Paclitaxel+Carboplatin

Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.

Paclitaxel 200 milligram per square meter (mg/m^2) administered IV on Day 1 of every 3 week cycle.

Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle.

The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles. Necitumumab may continue until Progressive Disease (PD), toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.

Drug: Necitumumab
Administered IV
Other Names:
  • LY3012211
  • IMC-11F8
Drug: Paclitaxel
Administered IV
Drug: Carboplatin
Administered IV
Active Comparator: Paclitaxel + Carboplatin
Paclitaxel 200 mg/m^2 administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles. After completion of chemotherapy, participants will be followed until radiographic documentation of PD.
Drug: Paclitaxel
Administered IV
Drug: Carboplatin
Administered IV

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed squamous NSCLC
  • Stage IV disease at time of study entry based on American Joint Committee on Cancer (AJCC) 7th edition
  • Measurable disease at time of study entry as defined by Response Evaluation Criteria in Solid Tumors, (RECIST) Version 1.1
  • Archived or recent tumor tissue (minimum of 5 unstained tissue slides or a paraffin-embedded tissue block) available for analysis of epidermal growth factor receptor (EGFR) protein expression by immunohistochemistry (IHC) and other biomarker assessments

Exclusion Criteria:

  • Nonsquamous NSCLC
  • Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor
  • Previous chemotherapy for NSCLC
  • Major surgery or received any investigational therapy in the 4 weeks prior to randomization
  • Chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed)
  • Brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants (Participants who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible)
  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: NCT01769391

  Show 51 Study Locations
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: NCT01769391     History of Changes
Other Study ID Numbers: 14790, I4X-MC-JFCL, 2012-003214-13
Study First Received: January 14, 2013
Last Updated: June 5, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Korea: Ministry for Health, Welfare and Family Affairs
Russia: Ministry of Health of the Russian Federation
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Hungary: National Institute of Pharmacy
Mexico: Ministry of Health

Keywords provided by Eli Lilly and Company:
NSCLC

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
Carboplatin
Paclitaxel
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014