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A Study of Gemcitabine-Carboplatin Plus Necitumumab (LY3012211) in Chemotherapy-Naïve Participants With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

Primary Purpose

Locally Advanced Squamous Non-Small Cell Lung Cancer, Metastatic Squamous Non-Small Cell Lung Cancer

Status

Withdrawn

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Necitumumab

Gemcitabine

Carboplatin

About this trial

This is an interventional treatment trial for Locally Advanced Squamous Non-Small Cell Lung Cancer focused on measuring Thoracic Neoplasms, Lung Diseases, Lung Cancer, Respiratory Tract Diseases, Respiratory Tract Neoplasms, Antineoplastic Agents, Monoclonal Antibodies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have confirmed diagnosis of locally advanced or metastatic NSCLC in Cohort 1 and metastatic NSCLC in Cohort 2, predominantly squamous histology. Squamous NSCLC diagnosis must be confirmed by histology or cytology local pathology report.
Participants in Cohort 1 are required to have epidermal growth factor receptor (EGFR) protein expressing tumor (defined by local immunohistochemistry test). This is not required for participants in Cohort 2.
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 an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1
Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy: Biologic agents (for example, antibodies) and Immunotherapy ≥4 weeks; Chest radiotherapy ≥4 weeks; Major surgery, excluding biopsy ≥4 weeks)
The participant has archived tumor tissue available for biomarker analyses.
Participants in Cohort 2 are required to have received 1 prior single-agent immune checkpoint inhibitor for squamous NSCLC.

Exclusion Criteria:

The participant has nonsquamous NSCLC
The participant has received prior anticancer therapy targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor.
The participant has received previous chemotherapy (including concurrent chemoradiation) for advanced NSCLC (participants who have received neo-adjuvant and/or adjuvant chemotherapy are eligible if the last administration occurred at least 1 year prior to start of therapy).
The participant has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants.
The participant has a bleeding tumor.
The participant has a history of arterial or venous thromboembolism within 3 months prior to study enrollment.
The participant has a history or evidence of current clinically-relevant coronary artery disease of current ≥ Class III as defined by Canadian Cardiovascular Society Angina Grading Scale (Campeau 1976) or congestive heart failure of current ≥ Class III as defined by the New York Heart Association.
The participant has experienced myocardial infarction within 6 months prior to study enrollment.

Sites / Locations

Fairview Southdale Oncology Clinic
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort 1: Necitumumab + Gemcitabine and Carboplatin

Cohort 2: Necitumumab + Gemcitabine and Carboplatin

Arm Description

Predominately European sites. Gemcitabine administered intravenously (IV) and carboplatin IV plus necitumumab IV.

Predominately United States sites. Gemcitabine administered IV and carboplatin IV plus necitumumab IV.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response

Secondary Outcome Measures

Overall Survival (OS)

Progression Free Survival (PFS)

Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, and Stable Disease

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab

Full Information

NCT ID

NCT02941601

First Posted

October 20, 2016

Last Updated

September 25, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02941601

Brief Title

A Study of Gemcitabine-Carboplatin Plus Necitumumab (LY3012211) in Chemotherapy-Naïve Participants With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

Official Title

A Multicenter, Phase 2 Study of Gemcitabine-Carboplatin Plus Necitumumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Withdrawn

Why Stopped

This was a strategic decision for business planning purposes and not out of concern for patient safety.

Study Start Date

November 2016 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The main purpose of this study is to evaluate the effectiveness and safety of gemcitabine-carboplatin plus necitumumab in chemotherapy-naïve participants with locally advanced or metastatic squamous non-small cell lung cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Squamous Non-Small Cell Lung Cancer, Metastatic Squamous Non-Small Cell Lung Cancer

Keywords

Thoracic Neoplasms, Lung Diseases, Lung Cancer, Respiratory Tract Diseases, Respiratory Tract Neoplasms, Antineoplastic Agents, Monoclonal Antibodies

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1: Necitumumab + Gemcitabine and Carboplatin

Arm Type

Experimental

Arm Description

Predominately European sites. Gemcitabine administered intravenously (IV) and carboplatin IV plus necitumumab IV.

Arm Title

Cohort 2: Necitumumab + Gemcitabine and Carboplatin

Arm Type

Experimental

Arm Description

Predominately United States sites. Gemcitabine administered IV and carboplatin IV plus necitumumab IV.

Intervention Type

Drug

Intervention Name(s)

Necitumumab

Other Intervention Name(s)

LY3012211

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

LY188011

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

Administered IV

Primary Outcome Measure Information:

Title

Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response

Time Frame

Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 18 Months)

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Time Frame

Baseline to Date of Death Due to Any Cause (Approximately 24 Months)

Title

Progression Free Survival (PFS)

Time Frame

Baseline to Measured Progressive Disease or Death (Approximately 24 Months)

Title

Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, and Stable Disease

Time Frame

Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 24 Months)

Title

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab

Time Frame

Cycle 1 Day 1 through Cycle 6 Day 1 (Approximately 4 Months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have confirmed diagnosis of locally advanced or metastatic NSCLC in Cohort 1 and metastatic NSCLC in Cohort 2, predominantly squamous histology. Squamous NSCLC diagnosis must be confirmed by histology or cytology local pathology report. Participants in Cohort 1 are required to have epidermal growth factor receptor (EGFR) protein expressing tumor (defined by local immunohistochemistry test). This is not required for participants in Cohort 2. 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 an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1 Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy: Biologic agents (for example, antibodies) and Immunotherapy ≥4 weeks; Chest radiotherapy ≥4 weeks; Major surgery, excluding biopsy ≥4 weeks) The participant has archived tumor tissue available for biomarker analyses. Participants in Cohort 2 are required to have received 1 prior single-agent immune checkpoint inhibitor for squamous NSCLC. Exclusion Criteria: The participant has nonsquamous NSCLC The participant has received prior anticancer therapy targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor. The participant has received previous chemotherapy (including concurrent chemoradiation) for advanced NSCLC (participants who have received neo-adjuvant and/or adjuvant chemotherapy are eligible if the last administration occurred at least 1 year prior to start of therapy). The participant has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants. The participant has a bleeding tumor. The participant has a history of arterial or venous thromboembolism within 3 months prior to study enrollment. The participant has a history or evidence of current clinically-relevant coronary artery disease of current ≥ Class III as defined by Canadian Cardiovascular Society Angina Grading Scale (Campeau 1976) or congestive heart failure of current ≥ Class III as defined by the New York Heart Association. The participant has experienced myocardial infarction within 6 months prior to study enrollment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Fairview Southdale Oncology Clinic

City

Edina

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

Facility Name

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.

City

Haine-St.- Paul

ZIP/Postal Code

7100

Country

Belgium

Facility Name

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

City

Bamberg

ZIP/Postal Code

96049

Country

Germany

Facility Name

City

Hannover

ZIP/Postal Code

30459

Country

Germany

Facility Name

City

Kassel

ZIP/Postal Code

34125

Country

Germany

Facility Name

City

Avellino

ZIP/Postal Code

50019

Country

Italy

Facility Name

City

Messina

ZIP/Postal Code

98122

Country

Italy

Facility Name

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

City

Pisa

ZIP/Postal Code

56125

Country

Italy

Facility Name

City

Baia Mare

ZIP/Postal Code

430291

Country

Romania

Facility Name

City

Bucuresti

ZIP/Postal Code

022328

Country

Romania

Facility Name

City

Cluj-Napoca

ZIP/Postal Code

400058

Country

Romania

Facility Name

City

Craiova

ZIP/Postal Code

200347

Country

Romania

Facility Name

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

City

St. Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

City

Bebington

ZIP/Postal Code

CH63 4JY

Country

United Kingdom

Facility Name

City

London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study of Gemcitabine-Carboplatin Plus Necitumumab (LY3012211) in Chemotherapy-Naïve Participants With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

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