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A Study in Non-Small Cell Lung Cancer

Primary Purpose

Non-Small-Cell Lung Carcinoma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Pemetrexed

Cisplatin

Cixutumumab

About this trial

This is an interventional treatment trial for Non-Small-Cell Lung Carcinoma focused on measuring lung cancer, advanced, non-small cell

Eligibility Criteria

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

Inclusion Criteria:

The participant has histologically or cytologically confirmed, nonsquamous (adenocarcinoma/large cell or other) NSCLC.
The participant has Stage IV disease at the time of study entry.
Participants with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, and stereotactic radiosurgery) ending at least 14 days prior to randomization, or after surgical resection performed at least 28 days prior to randomization. The participant may have no evidence of Grade 1 (or greater) Central Nervous System (CNS) hemorrhage based on pretreatment scans(performed within 21 days before randomization).
The participant has measurable or nonmeasurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 guidelines.
The participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
If prior adjuvant or neoadjuvant chemotherapy, the last dose of adjuvant or neoadjuvant treatment was administered at least 6 months prior to randomization.
The participant has adequate bone marrow reserve, and renal and hepatic function
The participant has fasting serum glucose less than or equal to 125 mg/dL, and hemoglobin A1C less than or equal to 6%.
Females with reproductive potential: Must have a negative serum or urine pregnancy test within 7 days prior to the first dose of any study drug.
Males and females with reproductive potential: Must agree to use medically approved contraceptive precautions during the study and for 6 months following the last dose of any study drug.
The participant has the ability to understand and the willingness to sign a written informed consent form.
Previous radiation therapy is allowed to less than 25% of the bone marrow, but should have been limited and must not have included whole pelvis radiation.
The participant has archived tumor tissue available for analysis (can be either primary tumor or metastases).
The participant has an estimated life expectancy of at least 12 weeks.

Exclusion Criteria:

Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Participants who have squamous histology.
The participant's tumor fully or partially contains Small Cell Lung Cancer (SCLC).
The participant has leptomeningeal disease.
The participant is currently or has previously received chemotherapy for advanced (Stage IV) NSCLC.
The participant has a history of treatment with other agents targeting the Insulin-like or Epidermal Growth factor receptors.
Participants who have received prior Pemetrexed treatment.
The patient has a known allergy/history of hypersensitivity reaction to any of the treatment components.
The participant has diabetes mellitus as defined by being treated with glucose lowering medications in the past 3 months prior to enrollment.
The participant has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant cardiac arrhythmia,or psychiatric/social situations that would limit compliance with study requirements.
The participant has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy.
The participant has undergone major surgery within 28 days prior to randomization.
The participant has received a prior autologous or allogeneic organ or tissue transplantation.
The participant is pregnant or lactating.
The participant has a history of another primary cancer, with the exception of the following: curatively resected nonmelanomatous skin cancer, curatively treated carcinoma in situ, or other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 5 years.
The participant has superior vena cava syndrome contraindicating hydration.
The participant has current clinically-relevant coronary artery disease (New York Heart Association III or IV) or uncontrolled congestive heart failure.
The participant has any Grade 2 (or greater) peripheral neuropathy.
The participant has clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
The participant is unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose less than or equal to 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
The participant is unwilling or unable to take premedications (folic acid, vitamin B12, or corticosteroids) required by the pemetrexed label.
The participant has received a recent (within 30 days of enrollment) or is receiving concurrent yellow fever vaccination.

Sites / Locations

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.
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.
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

Active Comparator

Arm Label

Pemetrexed + Cisplatin + Cixutumumab

Pemetrexed + Cisplatin

Arm Description

Induction Treatment: Pemetrexed 500 mg/m^2 plus cisplatin 75 mg/m^2 plus cixutumumab 20 mg/kg given intravenously (IV) on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for patients with significant tumor size reduction, after sponsor approval. Maintenance Therapy: Pemetrexed 500 mg/m^2 plus cixutumumab 20 mg/kg given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.

Induction Treatment: Pemetrexed 500 mg/m^2 plus cisplatin 75 mg/m^2 given intravenously (IV) on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for patients with significant tumor size reduction, after sponsor approval. Maintenance Therapy: Pemetrexed 500 mg/m^2 given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)

PFS was defined as the time from date of randomization until the date of disease progression, or death from any cause, whichever was first. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. Participants without documentation for disease progression or death were censored at the date of last tumor assessment. The PFS was estimated following the Kaplan-Meier method.

Secondary Outcome Measures

Percentage of Participants Achieving an Objective Response Rate (ORR)

The ORR is the percentage of all participants with Partial Response (PR) or Complete Response (CR) according to RECIST v1.1. Disease progression was defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions. ORR is confirmed best overall tumor response of CR and PR. CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD.

Overall Survival (OS)

Overall survival is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS will be censored on the last date the participant is known to be alive. OS was estimated using the Kaplan-Meier method.

Duration of Response (DOR)

Duration of response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that the criteria for PD is met, or death, is objectively documented. DOR was estimated using the Kaplan-Meier method. Disease progression was assessed via RECIST version 1.1, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing non-target lesions

Time to Progressive Disease (TTPS)

TTPS was defined as the time from the date of randomization until the date of disease progression. Disease progression was assessed via RECIST version 1.1, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing non-target lesions.TTPS was estimated using the Kaplan-Meier method.

Time to Worsening of Symptoms as Measured by Lung Cancer Symptom Scale (LCSS) Score

TTPS was defined as the time from the date of randomization until the date of worsening of symptoms as measured by Lung Cancer Symptom Scale (LCSS) score. Symptomatic progression was defined as an increase (worsening) of the Average Symptomatic Burden Index (ASBI) that is, the mean of the six major lung cancer specific symptom scores of the LCSS patient scale - ranging from 0 to 100 where higher score indicates worst outcome). For each participant, the maximum improvement over baseline score was calculated for each of the 9 LCSS items, ASBI and LCSS total score. Participants without event are censored at the date of the last LCSS assessment. TTPS was estimated using the Kaplan-Meier method.

Change in Tumor Size (CTS)

CTS was measured by percentage change of tumor size at the end of Cycle 2 comparing to baseline tumor size.

Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Cixutumumab, Cycle 1 (First Infusion) and Cycle 4 (Fourth Infusion)

PK: Area Under the Concentration Time Curve (AUC[0-inf]) of Cixutumumab, Cycle 1 (i.e. First Infusion)

PK: Area Under the Concentration Time Curve During 1 Dosing Interval (i.e. 504 hr, AUC(0-tau) of Cixutumumab, Cycle 4 (i.e. Fourth Infusion)

Pharmacodynamics (PD) Markers: Free Insulin-like Growth Factor-I (IGF-I, Total IGF-I, and IGF Binding Proteins (IGFBP-3)

Blood samples for the determination of PD marker concentrations were collected at the specified time points for all participants. Analysis of the following markers include free IGF-I, total IGF-I, and IGFBP-3.

Immunogenicity of Cixutumumab

Full Information

NCT ID

NCT01232452

First Posted

October 28, 2010

Last Updated

September 6, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01232452

Brief Title

A Study in Non-Small Cell Lung Cancer

Official Title

An Open-label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Cisplatin and Pemetrexed With or Without Cixutumumab as First-Line Therapy in Patients With Advanced Nonsquamous Non-Small Cell Lung Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary purpose of this study is to evaluate the hypothesis that cixutumumab given in combination with cisplatin and pemetrexed is superior to cisplatin and pemetrexed as first-line therapy for patients with advanced nonsquamous non-small cell lung carcinoma (NSCLC).

6. Conditions and Keywords

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

Non-Small-Cell Lung Carcinoma

Keywords

lung cancer, advanced, non-small cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

172 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pemetrexed + Cisplatin + Cixutumumab

Arm Type

Experimental

Arm Description

Arm Title

Pemetrexed + Cisplatin

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

Alimta, LY231514

Intervention Description

Administered intravenously (IV)

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Cixutumumab

Other Intervention Name(s)

LY3012217

Intervention Description

Administered IV

Primary Outcome Measure Information:

Title

Progression-free Survival (PFS)

Description

Time Frame

Randomization Date to Disease Progression or Death From Any Cause Up to 18.3 Months

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving an Objective Response Rate (ORR)

Description

Time Frame

Randomization to Disease Progression Up to 18.3 Months

Title

Overall Survival (OS)

Description

Time Frame

Randomization Date to Death From Any Cause Up to 20 Months

Title

Duration of Response (DOR)

Description

Time Frame

Time from Response to Disease Progression or Death from Any Cause Up to 20 Months

Title

Time to Progressive Disease (TTPS)

Description

Time Frame

Randomization Date to Disease Progression Up to 18.3 Months

Title

Time to Worsening of Symptoms as Measured by Lung Cancer Symptom Scale (LCSS) Score

Description

Time Frame

Time to worsening of symptoms as measured by LCSS score Up to 18.3 Months

Title

Change in Tumor Size (CTS)

Description

CTS was measured by percentage change of tumor size at the end of Cycle 2 comparing to baseline tumor size.

Time Frame

Change from baseline measurement to the end of Cycle 2, average of 42 days

Title

Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Cixutumumab, Cycle 1 (First Infusion) and Cycle 4 (Fourth Infusion)

Time Frame

First Infusion: [Prior to Infusion (of Cycle1): 1, 72, 168, 336 hours(hrs) and 504 hrs (i.e. Prior to Infusion of Cycle 2)] and Fourth Infusion; [Prior to Infusion (of Cycle 4),1,24,72,120,168,240,336 hrs and 504 hrs (i.e. Prior to Infusion of Cycle 5)]

Title

PK: Area Under the Concentration Time Curve (AUC[0-inf]) of Cixutumumab, Cycle 1 (i.e. First Infusion)

Time Frame

Prior to Infusion (of Cycle 1), 1, 72, 168, 336 hrs and 504 hrs (i.e. Prior to Infusion of Cycle 2)

Title

PK: Area Under the Concentration Time Curve During 1 Dosing Interval (i.e. 504 hr, AUC(0-tau) of Cixutumumab, Cycle 4 (i.e. Fourth Infusion)

Time Frame

Prior to Infusion (of Cycle 4), 1, 24, 72, 120, 168, 240, 336 hrs and 504 hrs (i.e. Prior to Infusion of Cycle 5)

Title

Pharmacodynamics (PD) Markers: Free Insulin-like Growth Factor-I (IGF-I, Total IGF-I, and IGF Binding Proteins (IGFBP-3)

Description

Time Frame

Preinfusion, Cycle 2, Cycle 4, Cycle 8, Postinfusion, 30-Day Follow-Up

Title

Immunogenicity of Cixutumumab

Time Frame

Preinfusion, Cycle1(C1): 1, 72, 168, 240, 336 hours(hrs); C2 and C3: 1, 168, 336 hrs; C4: 1, 24,72,120,168, 240, 336, 504 hrs, Postinfusion; 30 Day Follow Up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The participant has histologically or cytologically confirmed, nonsquamous (adenocarcinoma/large cell or other) NSCLC. The participant has Stage IV disease at the time of study entry. Participants with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, and stereotactic radiosurgery) ending at least 14 days prior to randomization, or after surgical resection performed at least 28 days prior to randomization. The participant may have no evidence of Grade 1 (or greater) Central Nervous System (CNS) hemorrhage based on pretreatment scans(performed within 21 days before randomization). The participant has measurable or nonmeasurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 guidelines. The participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1. If prior adjuvant or neoadjuvant chemotherapy, the last dose of adjuvant or neoadjuvant treatment was administered at least 6 months prior to randomization. The participant has adequate bone marrow reserve, and renal and hepatic function The participant has fasting serum glucose less than or equal to 125 mg/dL, and hemoglobin A1C less than or equal to 6%. Females with reproductive potential: Must have a negative serum or urine pregnancy test within 7 days prior to the first dose of any study drug. Males and females with reproductive potential: Must agree to use medically approved contraceptive precautions during the study and for 6 months following the last dose of any study drug. The participant has the ability to understand and the willingness to sign a written informed consent form. Previous radiation therapy is allowed to less than 25% of the bone marrow, but should have been limited and must not have included whole pelvis radiation. The participant has archived tumor tissue available for analysis (can be either primary tumor or metastases). The participant has an estimated life expectancy of at least 12 weeks. Exclusion Criteria: Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Participants who have squamous histology. The participant's tumor fully or partially contains Small Cell Lung Cancer (SCLC). The participant has leptomeningeal disease. The participant is currently or has previously received chemotherapy for advanced (Stage IV) NSCLC. The participant has a history of treatment with other agents targeting the Insulin-like or Epidermal Growth factor receptors. Participants who have received prior Pemetrexed treatment. The patient has a known allergy/history of hypersensitivity reaction to any of the treatment components. The participant has diabetes mellitus as defined by being treated with glucose lowering medications in the past 3 months prior to enrollment. The participant has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant cardiac arrhythmia,or psychiatric/social situations that would limit compliance with study requirements. The participant has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy. The participant has undergone major surgery within 28 days prior to randomization. The participant has received a prior autologous or allogeneic organ or tissue transplantation. The participant is pregnant or lactating. The participant has a history of another primary cancer, with the exception of the following: curatively resected nonmelanomatous skin cancer, curatively treated carcinoma in situ, or other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 5 years. The participant has superior vena cava syndrome contraindicating hydration. The participant has current clinically-relevant coronary artery disease (New York Heart Association III or IV) or uncontrolled congestive heart failure. The participant has any Grade 2 (or greater) peripheral neuropathy. The participant has clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry. The participant is unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose less than or equal to 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam). The participant is unwilling or unable to take premedications (folic acid, vitamin B12, or corticosteroids) required by the pemetrexed label. The participant has received a recent (within 30 days of enrollment) or is receiving concurrent yellow fever vaccination.

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

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

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38120

Country

United States

Facility Name

City

Spokane

State/Province

Washington

ZIP/Postal Code

99218

Country

United States

Facility Name

City

Buenos Aires

ZIP/Postal Code

1120

Country

Argentina

Facility Name

City

La Rioja

ZIP/Postal Code

5300

Country

Argentina

Facility Name

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Facility Name

City

Santa Fe

ZIP/Postal Code

3000

Country

Argentina

Facility Name

City

Viedma

ZIP/Postal Code

8500

Country

Argentina

Facility Name

City

Brussels

ZIP/Postal Code

1000

Country

Belgium

Facility Name

City

Duffel

ZIP/Postal Code

2570

Country

Belgium

Facility Name

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

City

Barretos

ZIP/Postal Code

14784700

Country

Brazil

Facility Name

City

Ijui

ZIP/Postal Code

98700 000

Country

Brazil

Facility Name

City

Porto Alegre

ZIP/Postal Code

90430-090

Country

Brazil

Facility Name

City

Rio De Janeiro

ZIP/Postal Code

20231-050

Country

Brazil

Facility Name

City

Salvador

ZIP/Postal Code

41253-190

Country

Brazil

Facility Name

City

Sao Jose Do Rio Preto

ZIP/Postal Code

15025-100

Country

Brazil

Facility Name

City

São Paulo

ZIP/Postal Code

01509-900

Country

Brazil

Facility Name

City

Oshawa

State/Province

Ontario

ZIP/Postal Code

L1G 2B9

Country

Canada

Facility Name

City

Caen

ZIP/Postal Code

14033

Country

France

Facility Name

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

Facility Name

City

Braunschweig

ZIP/Postal Code

38114

Country

Germany

Facility Name

City

Erfurt

ZIP/Postal Code

99089

Country

Germany

Facility Name

City

Grosshansdorf

ZIP/Postal Code

22927

Country

Germany

Facility Name

City

Halle

ZIP/Postal Code

06120

Country

Germany

Facility Name

City

Hannover

ZIP/Postal Code

30659

Country

Germany

Facility Name

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

City

Beer Yaakov

ZIP/Postal Code

70300

Country

Israel

Facility Name

City

Tel Hashomer

ZIP/Postal Code

52661

Country

Israel

Facility Name

City

Tel-Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

City

Milano

ZIP/Postal Code

20121

Country

Italy

Facility Name

City

Orbassano

ZIP/Postal Code

10043

Country

Italy

Facility Name

City

Perugia

ZIP/Postal Code

06156

Country

Italy

Facility Name

City

Saronno

ZIP/Postal Code

21047

Country

Italy

Facility Name

City

Harderwijk

ZIP/Postal Code

3844 DG

Country

Netherlands

Facility Name

City

S-Hertogenbosch

ZIP/Postal Code

5223 GZ

Country

Netherlands

Facility Name

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

City

Girona

ZIP/Postal Code

17007

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

City

Palma De Mallorca

ZIP/Postal Code

07198

Country

Spain

Facility Name

City

Edirne

ZIP/Postal Code

22000

Country

Turkey

Facility Name

City

Zeytinburnu

ZIP/Postal Code

034760

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Learn more about this trial

A Study in Non-Small Cell Lung Cancer

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