NCT01769391

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2013

Typical duration for phase_2

Geographic Reach
6 countries

51 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 5, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

2.2 years

First QC Date

January 14, 2013

Results QC Date

March 31, 2016

Last Update Submit

September 5, 2019

Conditions

Squamous Non Small Cell Lung Cancer

Keywords

NSCLC

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])

    The denominator of ORR (Objective Response Rate) includes each participant enrolled who received any amount of study drug (necitumumab, gemcitabine, and/or cisplatin), and who had a complete radiographic assessment at baseline and at least one complete radiographic assessment post-baseline. The numerator includes those participants counted in the denominator with a confirmed best overall tumor response of partial or complete response (Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

    Baseline to Disease Progression or Death (Up to 24 Months)

Secondary Outcomes (7)

  • Overall Survival (OS)

    Randomization to Date of Death (Up to 24 Months)

  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab

    Pre-infusion Cycle 1, Day 1; Cycle 3, Day 1; Cycle 5; Day 1 (within 2 hours prior to beginning of infusion)

  • Percentage of Participants With Anti Necitumumab Antibodies

    Baseline to End of Cycle 6

  • Progression-Free Survival

    Randomization to Progressive Disease or Death (Up to 24 Months)

  • Percentage of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])

    Baseline to Progressive Disease and/or Death (Estimated up to 24 Months)

  • +2 more secondary outcomes

Study Arms (2)

Necitumumab +Paclitaxel+Carboplatin

EXPERIMENTAL

Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) 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: NecitumumabDrug: PaclitaxelDrug: Carboplatin

Paclitaxel + Carboplatin

ACTIVE COMPARATOR

Paclitaxel 200 mg/m² 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: PaclitaxelDrug: Carboplatin

Interventions

NecitumumabDRUG

Administered IV

Also known as: LY3012211, IMC-11F8
Necitumumab +Paclitaxel+Carboplatin
PaclitaxelDRUG

Administered IV

Necitumumab +Paclitaxel+CarboplatinPaclitaxel + Carboplatin
CarboplatinDRUG

Administered IV

Necitumumab +Paclitaxel+CarboplatinPaclitaxel + Carboplatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (51)

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.

Jonesboro, Arkansas, 72401, United States

Location

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Los Angeles, California, 90048, United States

Location

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Sacramento, California, 95816, United States

Location

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Colorado Springs, Colorado, 80907, United States

Location

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Fleming Island, Florida, 32003, United States

Location

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Fort Myers, Florida, 33916, United States

Location

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Miami Beach, Florida, 33140, United States

Location

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Port Saint Lucie, Florida, 34952, United States

Location

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St. Petersburg, Florida, 33705, United States

Location

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Macon, Georgia, 31201, United States

Location

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Marietta, Georgia, 30060, United States

Location

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Savannah, Georgia, 31404, United States

Location

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Valdosta, Georgia, 31602, United States

Location

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Wichita, Kansas, 67214, United States

Location

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Louisville, Kentucky, 40202, United States

Location

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Kalamazoo, Michigan, 49007, United States

Location

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Lansing, Michigan, 48910, United States

Location

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Woodbury, Minnesota, 55125, United States

Location

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Billings, Montana, 59101, United States

Location

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Lincoln, Nebraska, 68510, United States

Location

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Cherry Hill, New Jersey, 08003, United States

Location

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Hackensack, New Jersey, 07601, United States

Location

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Latham, New York, 12110, United States

Location

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Cincinnati, Ohio, 45242, United States

Location

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Eugene, Oregon, 97401, United States

Location

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Charleston, South Carolina, 29425, United States

Location

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Columbia, South Carolina, 29210, United States

Location

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Chattanooga, Tennessee, 37404, United States

Location

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Memphis, Tennessee, 38120, United States

Location

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Nashville, Tennessee, 37203, United States

Location

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Fort Worth, Texas, 76104, United States

Location

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The Woodlands, Texas, 77380, United States

Location

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Richmond, Virginia, 23230, United States

Location

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Großhansdorf, 22927, Germany

Location

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Heidelberg, 69126, Germany

Location

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Immenhausen, 34376, Germany

Location

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Münster, 48149, Germany

Location

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Chihuahua City, 31000, Mexico

Location

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León, 37000, Mexico

Location

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Mexico City, 6700, Mexico

Location

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Monterrey, 64000, Mexico

Location

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Głuchołazy, 48-340, Poland

Location

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Olsztyn, 10-357, Poland

Location

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Otwock, 05-400, Poland

Location

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Poznan, 60-693, Poland

Location

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Radom, 26-617, Poland

Location

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Warsaw, 02-781, Poland

Location

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Saint Petersburg, 194291, Russia

Location

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Incheon, 405-760, South Korea

Location

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Seoul, 135-710, South Korea

Location

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Ulsan, 682-714, South Korea

Location

MeSH Terms

Interventions

necitumumabPaclitaxelCarboplatin

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2013

First Posted

January 16, 2013

Study Start

January 1, 2013

Primary Completion

April 1, 2015

Study Completion

July 1, 2017

Last Updated

September 20, 2019

Results First Posted

May 5, 2016

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations

RU(1)PL(6)KR(3)ME(4)US(33)DE(4)