Non-Small-Cell Lung CarcinomaPhase 2NCT01232452
A Study in Non-Small Cell Lung Cancer
A Phase 2 study testing Pemetrexed, Cisplatin and Cixutumumab in people with Non-Small-Cell Lung Carcinoma, run by Eli Lilly and Company at 44 sites in 12 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma
- What is being tested?
- Pemetrexed, Cisplatin and Cixutumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 44 sitesin 12 countries
- Study dates
- Apr 2011to Jun 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
44 sites in 12 countries.
44 sites in 12 countries
Brazil7 sites
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.
Barretos, 14784700
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Ijuí, 98700 000
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Porto Alegre, 90430-090
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Rio de Janeiro, 20231-050
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Salvador, 41253-190
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São José do Rio Preto, 15025-100
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São Paulo, 01509-900
Germany6 sites
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Braunschweig, 38114
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Erfurt, 99089
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Großhansdorf, 22927
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Halle, 06120
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Hanover, 30659
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Ulm, 89081
United States5 sites
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Chicago, Illinois, 60611
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Hackensack, New Jersey, 07601
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Memphis, Tennessee, 38120
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Portland, Oregon, 97213
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Spokane, Washington, 99218
Argentina5 sites
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Buenos Aires, 1120
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La Rioja, 5300
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Mendoza, 5500
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Santa Fe, 3000
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Viedma, 8500
Italy4 sites
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Milan, 20121
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Orbassano, 10043
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Perugia, 06156
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Saronno, 21047
Spain4 sites
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Barcelona, 08003
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Girona, 17007
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Madrid, 28041
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Palma de Mallorca, 07198
Belgium3 sites
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Brussels, 1000
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Duffel, 2570
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Liège, 4000
Israel3 sites
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Beer Yaakov, 70300
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Tel Aviv, 64239
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Tel HaShomer, 52661
France2 sites
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Caen, 14033
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Clermont-Ferrand, 63003
Netherlands2 sites
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's-Hertogenbosch, 5223 GZ
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Harderwijk, 3844 DG
Turkey (Türkiye)2 sites
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Edirne, 22000
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Zeytinburnu, 034760
Canada1 site
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Oshawa, Ontario, L1G 2B9
About this study
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
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).
- Conditions
- Non-Small-Cell Lung Carcinoma
- Being tested
- Pemetrexed, Cisplatin, Cixutumumab
- Keywords
- lung cancer, advanced, non-small cell
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
Also called Alimta, LY231514
Administered intravenously (IV)
CisplatinDrug
Administered IV
CixutumumabDrug
Also called LY3012217
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Pemetrexed + Cisplatin + Cixutumumab | Experimental | 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. Receives: Drug: Pemetrexed; Drug: Cisplatin; Drug: Cixutumumab |
| Pemetrexed + Cisplatin | Active comparator | 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. Receives: Drug: Pemetrexed; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Randomization Date to Disease Progression or Death From Any Cause Up to 18.3 Months
Secondary outcomes (11)
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.
Measured: Randomization to Disease Progression Up to 18.3 Months
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.
Measured: Randomization Date to Death From Any Cause Up to 20 Months
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
Measured: Time from Response to Disease Progression or Death from Any Cause Up to 20 Months
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.
Measured: Randomization Date to Disease Progression Up to 18.3 Months
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.
Measured: Time to worsening of symptoms as measured by LCSS score Up to 18.3 Months
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.
Measured: Change from baseline measurement to the end of Cycle 2, average of 42 days
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Cixutumumab, Cycle 1 (First Infusion) and Cycle 4 (Fourth Infusion)
Measured: 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)]
PK: Area Under the Concentration Time Curve (AUC[0-inf]) of Cixutumumab, Cycle 1 (i.e. First Infusion)
Measured: Prior to Infusion (of Cycle 1), 1, 72, 168, 336 hrs and 504 hrs (i.e. Prior to Infusion of Cycle 2)
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)
Measured: 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)
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.
Measured: Preinfusion, Cycle 2, Cycle 4, Cycle 8, Postinfusion, 30-Day Follow-Up
Immunogenicity of Cixutumumab
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startApr 2011
- Primary completionJan 2013
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Small-Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232452
- Sponsor's protocol ID
- 13973
- Other IDs
- I5A-MC-JAEM
- Status last verified
- Sep 2019
- First submitted
- 28 Oct 2010
- Last updated
- 20 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01232452
- Acronym / sponsor ID
- 13973
- Conditions
- Non-Small-Cell Lung Carcinoma
- Keywords
- lung cancer, advanced, non-small cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Posted 12 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pemetrexed + Cisplatin + Cixutumumab | Experimental | Drug: Pemetrexed, Drug: Cisplatin, Drug: CixutumumabInduction 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. |
| Pemetrexed + Cisplatin | Active comparator | Drug: Pemetrexed, Drug: CisplatinInduction 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PemetrexedAlso: Alimta, LY231514Administered intravenously (IV) | Drug | Pemetrexed + Cisplatin, Pemetrexed + Cisplatin + Cixutumumab |
| CisplatinAdministered IV | Drug | Pemetrexed + Cisplatin, Pemetrexed + Cisplatin + Cixutumumab |
| CixutumumabAlso: LY3012217Administered IV | Drug | Pemetrexed + Cisplatin + Cixutumumab |
Primary outcome
Progression-free Survival (PFS)
Time frame: Randomization Date to Disease Progression or Death From Any Cause Up to 18.3 Months
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.
11 secondary outcomes
Percentage of Participants Achieving an Objective Response Rate (ORR)
Time frame: Randomization to Disease Progression Up to 18.3 Months
Overall Survival (OS)
Time frame: Randomization Date to Death From Any Cause Up to 20 Months
Duration of Response (DOR)
Time frame: Time from Response to Disease Progression or Death from Any Cause Up to 20 Months
Time to Progressive Disease (TTPS)
Time frame: Randomization Date to Disease Progression Up to 18.3 Months
Time to Worsening of Symptoms as Measured by Lung Cancer Symptom Scale (LCSS) Score
Time frame: Time to worsening of symptoms as measured by LCSS score Up to 18.3 Months
Change in Tumor Size (CTS)
Time frame: Change from baseline measurement to the end of Cycle 2, average of 42 days
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)]
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)
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)
Pharmacodynamics (PD) Markers: Free Insulin-like Growth Factor-I (IGF-I, Total IGF-I, and IGF Binding Proteins (IGFBP-3)
Time frame: Preinfusion, Cycle 2, Cycle 4, Cycle 8, Postinfusion, 30-Day Follow-Up
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
44 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemetrexed, Cisplatin and Cixutumumab in people with Non-Small-Cell Lung Carcinoma, run by Eli Lilly and Company at 44 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Brazil, Germany, United States, Argentina, Italy and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: Randomization Date to Disease Progression or Death From Any Cause Up to 18.3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.