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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer

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Trial Information

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


Multinational, randomized, multicenter, open-label Phase 3 study of 634 patients with
advanced, nonsquamous (Stage IV) NSCLC. Patients will be randomized on a 1:1 basis to
receive first-line necitumumab plus chemotherapy consisting of pemetrexed and cisplatin in
study Arm A, or first-line pemetrexed-cisplatin chemotherapy alone in 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 (computed tomography or magnetic resonance
imaging) of disease status 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 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 nonsquamous (adenocarcinoma/large cell
or other) non small cell lung cancer

- Has Stage IV disease at the time of study entry

- Measurable or nonmeasurable disease (as defined by the Response Evaluation Criteria
in Solid Tumors RECIST 1.0) at the time of study entry (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
alopecia)

- Has an Eastern Cooperative Oncology Group performance status score of 0-2

- 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 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 patients 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

Exclusion Criteria:

- Has squamous non small cell lung cancer

- 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

- 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)

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

- 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, potentially precluding protocol compliance

- Has 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 The patient has a known allergy /
history of hypersensitivity reaction to any of the treatment components, including
any ingredient used in the formulation of 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:

Interventional

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 474 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 30 months

Safety Issue:

No

Principal Investigator

E-mail: ClinicalTrials@ ImClone.com

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

13908

NCT ID:

NCT00982111

Start Date:

November 2009

Completion Date:

December 2013

Related Keywords:

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

Name

Location

ImClone Investigational SiteNew York, New York  10021