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A Randomized, Multicenter, Open-Label Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

Phase 3
18 Years
Open (Enrolling)
Non Small Cell Lung Cancer

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Trial Information

A Randomized, Multicenter, Open-Label Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

Approximately 1080 patients (age ≥ 18 years) with histologically- or
cytologically-confirmed, stage iv squamous-cell NSCLC, who have received no prior therapy
for metastatic disease, will be randomized on a 1:1 basis to receive first-line necitumumab
(IMC-11F8) plus chemotherapy consisting of gemcitabine and cisplatin in study Arm A, or
gemcitabine-cisplatin chemotherapy alone in study Arm B. Baseline radiographic assessment of
disease will be performed within 21 days prior to randomization (first treatment will be
administered within 7 days following randomization). Patients will undergo radiographic
assessment of disease status (computed tomography or magnetic resonance imaging) every 6
weeks (± 3 days), until there is radiographic documentation of progressive disease (PD).
Chemotherapy will continue for a maximum of six cycles in each arm (or until there is
radiographic documentation of PD, toxicity requiring cessation, protocol noncompliance or
withdrawal of consent); patients in Arm A only will continue to receive necitumumab
(IMC-11F8) until there is radiographic documentation of PD, toxicity requiring cessation,
protocol noncompliance, or withdrawal of consent.

After the end-of-study-visit (following PD), follow-up information regarding further
anticancer treatment and survival will be collected every 2 months (± 7 days). For patients
who discontinue study for reasons other than PD (eg, symptomatic deterioration), information
on disease progression will also be collected until PD is documented. Follow-up will
continue as long as the patient is alive, or until the end of the trial.

Inclusion Criteria:

- Has histologically or cytologically confirmed squamous NSCLC

- Has Stage IV disease at the time of study entry

- Measurable or nonmeasurable disease at the time of study entry as defined by the
Response Evaluation Criteria in Solid Tumors (RECIST 1.0) (patients with only truly
nonmeasurable disease are not eligible)

- Has resolution to Grade ≤ 1 of all clinically significant toxic effects of prior
chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of

- Has adequate hepatic function

- Has adequate renal function

- Has adequate hematologic function

- If female, is surgically sterile, postmenopausal, or compliant with a highly
effective contraceptive method (failure rate < 1%) during and for 6 months after the
treatment period (oral hormonal contraception alone is not considered highly
effective and must be used in combination with a barrier method)

- If male, the patient is surgically sterile or compliant with a highly effective
contraceptive regimen during and for 6 months after the treatment period

- Female patients of childbearing potential must have a negative serum pregnancy test
within 7 days prior to randomization

- Has archived tumor tissue available for analysis of EGFR and KRAS mutation status (by
PCR) and EGFR gene copy number (by FISH); minimum of four slides, paraffin-embedded
tissue, required

Exclusion Criteria:

- Has nonsquamous NSCLC (adenocarcinoma/large cell or other)

- Has received prior anticancer therapy with monoclonal antibodies, signal transduction
inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor
(VEGF), or VEGF receptor

- Has received previous chemotherapy for advanced NSCLC (patients who have received
adjuvant chemotherapy are eligible if the last administration of the prior adjuvant
regimen occurred at least 1 year prior to randomization)

- Has undergone major surgery or received any investigational therapy in the 4 weeks
prior to randomization

- Has undergone chest irradiation within 12 weeks prior to randomization (except
palliative irradiation of bone lesions, which is allowed)

- Has brain metastases that are symptomatic or require ongoing treatment with steroids
or anticonvulsants. Patients who have undergone previous radiotherapy for brain
metastases, who are now nonsymptomatic and no longer require treatment with steroids
or anticonvulsants, are eligible

- Has superior vena cava syndrome contraindicating hydration

- Has current clinically-relevant coronary artery disease or uncontrolled congestive
heart failure

- Has experienced myocardial infarction within 6 months prior to randomization

- Has an ongoing or active infection (requiring antibiotics), including active
tuberculosis or known infection with the human immunodeficiency virus

- Has a history of significant neurological or psychiatric disorders, including
dementia, seizures, or bipolar disorder

- Has any NCI-CTCAE Version 3.0 Grade ≥ 2 peripheral neuropathy

- Has significant third space fluid retention, requiring repeated drainage

- Has any other serious uncontrolled medical disorders or psychological conditions that
would, in the opinion of the investigator, limit the patient's ability to complete
the study or sign an informed consent document

- Has a known allergy / history of hypersensitivity reaction to any of the treatment
components, including any ingredient used in the formulation of necitumumab
(IMC-11F8), or any other contraindication to one of the administered treatments

- Is pregnant or breastfeeding

- Has a known history of drug abuse

- Has a concurrent active malignancy other than adequately-treated basal cell carcinoma
of the skin or preinvasive carcinoma of the cervix. A patient with previous history
of malignancy other than NSCLC is eligible, provided that he/she has been free of
disease for ≥ 3 years

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Kaplan-Meier Estimate for Overall survival time (OS)

Outcome Description:

Overall survival time is measured as randomization to date of death from any cause. Participants who are alive when the study achieves 844 deaths or is lost to follow-up will have their overall survival time censored on the last date the participant is known to be alive.

Outcome Time Frame:

Approximately 31 months

Safety Issue:


Principal Investigator

E-mail: ClinicalTrials

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:




Start Date:

January 2010

Completion Date:

December 2014

Related Keywords:

  • Non Small Cell Lung Cancer
  • Squamous
  • Non Small Cell Lung Cancer
  • First line treatment
  • Monoclonal
  • Antibodies
  • Epidermal Growth Factor Receptor
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



ImClone Investigational SiteIndianapolis, Indiana  46202
ImClone Investigational SiteNew York, New York  10021
ImClone Investigational SiteSt. Charles, Missouri  63301
ImClone Investigational SiteBakersfield, California  93309
ImClone Investigational SiteDecatur, Illinois  62526
ImClone Investigational SiteLouisville, Kentucky  40202
ImClone Investigational SiteBaltimore, Maryland  21204
ImClone Investigational SiteCleveland, Ohio  44134
ImClone Investigational SiteMemphis, Tennessee  38104
ImClone Investigational SiteNorfolk, Virginia  23502
ImClone Investigational SiteLittle Rock, Arkansas  72205
ImClone Investigational SitePhiladelphia, Pennsylvania  19107
ImClone Investigational SiteTucson, Arizona  85712
ImClone Investigational SiteKansas City, Kansas  66160
ImClone Investigational SiteGrand Island, Nebraska  68803