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Non-Small Cell Lung CancerPhase 2NCT00870870

A Study of IMC-A12 (Cixutumumab) With and Without Other Standard Chemotherapies in Participants With Lung Cancer Who Have Not Received Chemotherapy Before

A Phase 2 study testing Gemcitabine, Cisplatin and IMC-A12 (cixutumumab) in people with Non-Small Cell Lung Cancer, run by Eli Lilly and Company at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the number of participants whose cancer shrinks or disappears after treatment on the study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Gemcitabine, Cisplatin and IMC-A12 (cixutumumab)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
12 sitesUnited States
Study dates
Mar 2009to May 2012
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

  • Has histologically or cytologically confirmed, Stage IIIb - IV NSCLC
  • Has metastatic disease
  • Has a tumor measurable according to Response Evaluation Criteria in Solid Tumors (RECIST)
  • Has adequate hematologic function
  • Has adequate hepatic function
  • Has adequate renal function
  • Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation

Who cannot join

  • Has uncontrolled brain metastases
  • Has leptomeningeal disease
  • Has received previous chemotherapy for NSCLC (participants who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization)
  • Receiving any other investigational agent(s)
  • Has a history of treatment with other agents targeting the insulin-like growth factor (IGF) or the epidermal growth factor (EGF) receptor
  • Has a known allergy / history of hypersensitivity reaction to any of the treatment components
Show all 14Show fewer
  • Has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range [fasting glucose <160 milligrams per deciliter (mg/dL) or below the upper limit of normal (ULN) and hemoglobin A1C≤ 7%] and that they are on a stable dietary or therapeutic regimen for this condition
  • Has an uncontrolled intercurrent illness
  • Pregnant or lactating
  • Has a history of another primary cancer, with the exception of: a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 3 years
  • Has superior vena cava syndrome contraindicating hydration
  • Has current clinically-relevant coronary artery disease (New York Heart Association III or IV) or uncontrolled congestive heart failure
  • Has any National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version (v) 3.0 Grade ≥2 peripheral neuropathy
  • Has significant third space fluid retention, requiring repeated drainage

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • ImClone Investigational Site

    Albuquerque, New Mexico, 87131

  • ImClone Investigational Site

    Anniston, Alabama, 36207

  • ImClone Investigational Site

    Atlanta, Georgia, 30341

  • ImClone Investigational Site

    Chicago, Illinois, 60612

  • ImClone Investigational Site

    Chicago, Illinois, 60637

  • ImClone Investigational Site

    Cincinnati, Ohio, 45247

  • ImClone Investigational Site

    La Jolla, California, 92093

  • ImClone Investigational Site

    New York, New York, 10011

  • ImClone Investigational Site

    New York, New York, 10021

  • ImClone Investigational Site

    New York, New York, 10032

  • ImClone Investigational Site

    Orange, California, 92868

  • ImClone Investigational Site

    Orlando, Florida, 32806

Other trials in United States

About this study

Official title: Randomized, Open Label, Stratified Phase 2 Trial of Gemcitabine, Carboplatin, and Cetuximab With Vs. Without IMC-A12 in Chemotherapy-Naive Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

The purpose of this study is to determine the number of participants whose cancer shrinks or disappears after treatment on the study.

Read the detailed description

Participants with Stage IIIb or IV non-small cell lung cancer (NSCLC) who have not received previous chemotherapy will be stratified, based on disease histology (squamous versus [vs.] nonsquamous).

Being tested
Gemcitabine, Cisplatin, IMC-A12 (cixutumumab), Cetuximab, Carboplatin
Keywords
Tumors, Antibodies, Monoclonal, Stage IIIb Metastatic Non-Small Cell Lung Cancer, Stage IV Metastatic Non-Small Cell Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

    1000 milligrams per square meter (mg/m^2) on Days 1 and 8 of each cycle

    [First 6 cycles (18 weeks)]

  • CisplatinDrug

    75 mg/m^2 on Day 1 of each cycle

    [First 6 cycles (18 weeks)]

  • IMC-A12 (cixutumumab)Biological

    Also called Cixutumumab, LY3012217

    6 milligrams per kilogram (mg/kg) intravenous (IV) infusion, administered once per week (on Days 1, 8, and 15 of each cycle)

    [First 6 cycles (18 weeks)]

  • CetuximabBiological

    Also called Erbitux®

    400 mg/m^2 IV infusion, administered on Day 1 of Cycle 1, 250 mg/m^2 once per week thereafter

    [First 6 cycles (18 weeks)]

  • IMC-A12 (cixutumumab)Biological

    Also called Cixutumumab, LY3012217

    10 mg/kg IV infusion, administered once every 2 weeks

    (Maintenance therapy)

  • CetuximabBiological

    Also called Erbitux®

    500 mg/m^2 IV infusion, administered once every 2 weeks

    (Maintenance therapy)

  • CarboplatinDrug

    Area under the curve (AUC) = 5, Day 1 of each cycle

    [First 6 cycles (18 weeks)]

    *Carboplatin will be replaced by Cisplatin

Study groups in NCT00870870
Study groupRoleWhat they receive
GCiC + IMC-A12 (Gemcitabine/Cisplatin/Cetuximab + Cixutumumab)ExperimentalCycles repeat every 3 weeks for first 6 cycles (18 weeks) and then once every 2 weeks (maintenance therapy) until disease progression, intolerable toxicity, withdrawal of consent or other withdrawal criteria met *Cisplatin will replace Carboplatin. Gemcitabine/Carboplatin/Cetuximab (GCC) plus cixutumumab will change to Gemcitabine/Cisplatin/Cetuximab (GCiC) plus cixutumumab (participants enrolled subsequent to this change will receive gemcitabine, cisplatin and cetuximab, plus cixutumumab)
Receives: Drug: Gemcitabine; Drug: Cisplatin; Biological: IMC-A12 (cixutumumab); Biological: Cetuximab; Drug: Carboplatin
GCiC (Gemcitabine/Cisplatin/Cetuximab)Active comparatorCycles repeat every 3 weeks for 6 cycles (18 weeks) and then once every 2 weeks (maintenance therapy) until disease progression, intolerable toxicity, withdrawal of consent or other withdrawal criteria met *Cisplatin will replace Carboplatin. GCC plus cixutumumab will change to GCiC plus cixutumumab (participants enrolled subsequent to this change will receive gemcitabine, cisplatin and cetuximab, plus cixutumumab)
Receives: Drug: Gemcitabine; Drug: Cisplatin; Biological: Cetuximab; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

    ORR was defined as the percentage of participants achieving either CR or PR. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and the normalization of the tumour marker level. PR was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Percentage of participants is calculated as a total number of participants with CR or PR / total number of participants treated * 100.

    Measured: Randomization to measured progressive disease (PD) (up to 16.9 months)

Secondary outcomes (14)

  1. Overall Survival (OS)

    OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact.

    Measured: Randomization to death due to any cause or censor (up to 30.4 months)

  2. Progression-Free Survival (PFS)

    PFS was defined as the duration from the date of randomization until disease progression or death due to any cause, whichever occurred first. Response was defined using RECIST, v 1.0 criteria. PD was defined as having a ≥20% increase in sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants who were alive and without disease progression, PFS was censored at the date of last objective tumor assessment. For participants who did not experience disease progression and were lost to follow-up, PFS was censored at the date of the last objective tumor assessment or the date of last contact.

    Measured: Randomization to PD or death due to any cause or censor (up to 16.9 months)

  3. Time To Progression (TTP)

    TTP was defined as the duration from the date of randomization until the date of disease progression. Response was defined using RECIST v 1.0 criteria. PD was defined as having a ≥20% increase in the sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants without disease progression, TTP was censored at the date of last objective tumor assessment. For participants without disease progression and were subsequently lost to follow-up, TTP was censored at the date of last follow-up visit or at the date of last contact.

    Measured: Randomization to months until PD or censor (up to 16.9 months)

  4. Duration of Response

    The duration of CR or PR was defined as the time from first objective status assessment of CR or PR to the first time of disease progression or death. Response was defined using RECIST v 1.0 criteria. CR was defined as the disappearance of all target lesions and non-target lesions. PR was defined as having at least a 30% decrease in sum of LD of target lesions. Duration of response was censored on the date of last tumor assessment for participants who were alive and have no evidence of disease progression.

    Measured: Date of first response to the date of PD or death due to any cause or censor ( up to 15.5 months)

  5. Number of Participants With Adverse Events (AEs) or Deaths

    Data presented are the number of participants who experienced 1 or more AEs, serious AEs (SAEs), and AEs that lead to death during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report.

    Measured: Randomization to last dose of study medication (up to 11.7 months) plus 30-day safety follow-up

  6. Serum Anti-Cixutumumab Antibody Assessment (Immunogenicity)

    Measured: Prior to first infusions of Cycles 1, 3, and 5 and 30 days following the end of therapy

  7. Maximum Concentration (Cmax) of Cixutumumab at Study Day 1

    Measured: Day 1

  8. Cmax of Cixutumumab for Cycle 1

    Measured: Week 1 (Cycle 1, Day 1)

  9. Cmax of Cixutumumab for Cycle 3

    Measured: Week 7 (Cycle 3, Day 1)

  10. Cmax of Cixutumumab Cycle 5

    Measured: Week 13 (Cycle 5, Day 1)

  11. Minimum Concentration (Cmin) of Cixutumumab at Study Day 1

    Measured: Day 1

  12. Cmin of Cixutumumab for Cycle 1

    Measured: Week 1 (Cycle 1, Day 1)

  13. Cmin of Cixutumumab for Cycle 3

    Measured: Week 7 (Cycle 3, Day 1)

  14. Cmin of Cixutumumab for Cycle 5

    Measured: Week 13 (Cycle 5, Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionApr 2012
  4. Study completionMay 2012

Resources

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
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00870870
Sponsor's protocol ID
13930
Other IDs
CP02-0860, CP13-0811, I5A-IE-JAEF
Status last verified
May 2018
First submitted
26 Mar 2009
Last updated
1 Jun 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine, Cisplatin and IMC-A12 (cixutumumab) in people with Non-Small Cell Lung Cancer, run by Eli Lilly and Company at 12 sites in United States.

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 7 inclusion and 14 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 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. 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 1 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?

Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] (time frame: Randomization to measured progressive disease (PD) (up to 16.9 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00870870.

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 1 Jun 2018.

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