A Study of Necitumumab and Chemotherapy in Participants With Stage IV Squamous Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified May 2013 by Eli Lilly and Company
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01769391
First received: January 14, 2013
Last updated: May 14, 2013
Last verified: May 2013
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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: | March 2017 |
| Estimated Primary Completion Date: | April 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:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769391
Show 61 Study Locations
Contacts
| Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 |
Show 61 Study LocationsSponsors 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: | May 14, 2013 |
| 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 May 23, 2013