A Study of Pemetrexed and Carboplatin/Cisplatin or Gemcitabine and Carboplatin/Cisplatin With or Without IMC-1121B in Participants Previously Untreated With Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC)



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/16/2018
Start Date:September 2010
End Date:April 2018

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An Open-label, Multicenter, Randomized, Phase 2 Study of a Recombinant Human Anti-VEGFR-2 Monoclonal Antibody, IMC-1121B in Combination With Platinum-based Chemotherapy Versus Platinum-based Chemotherapy Alone as First-line Treatment of Patients With Recurrent or Advanced Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to determine if participants with Stage IV NSCLC have a better
outcome when treated with IMC-1121B in combination with pemetrexed + carboplatin/cisplatin or
gemcitabine + carboplatin/cisplatin than when treated with pemetrexed + carboplatin/cisplatin
or gemcitabine + carboplatin/cisplatin alone.


Inclusion Criteria:

- Confirmed NSCLC

- Stage IV disease at the time of study entry

- Measurable disease at the time of study entry

- Resolution to Grade ≤ 1 Adverse Events, of all clinically significant toxic effects of
prior chemotherapy, surgery, radiotherapy, or hormonal therapy (except alopecia)

- Adequate hematologic function, hepatic function, renal function and coagulation
function

- If sexually active, must be post-menopausal, surgically sterile, or using effective
contraception; and agrees to use adequate contraception during the study period and
for up to 6 months after the last dose of study medication

- Female participants of childbearing potential must have a negative serum pregnancy
test

Exclusion Criteria:

- Has cirrhosis at a level of Child-Pugh B (or worse), or cirrhosis and a history of
hepatic encephalopathy, or ascites resulting from cirrhosis and requiring ongoing
treatment with diuretics and/or paracentesis

- Tumor wholly or partially contains small cell lung cancer

- Untreated central nervous system (CNS) metastases, eligible if they are clinically
stable with regard to neurologic function, off all steroids after cranial irradiation
at least 2 weeks prior or after surgical resection performed at least 4 weeks prior to
randomization

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

- Received prior therapy with monoclonal antibodies, signal transduction inhibitors, or
any therapies targeting the vascular endothelial growth factor (VEGF) or vascular
endothelial growth factor receptor (VEGFR)

- Receiving concurrent treatment with other anticancer therapy

- Has received previous chemotherapy for Stage IV 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)

- Has radiologically documented evidence of major blood vessel invasion or encasement by
cancer

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

- Ongoing or active infection

- History of significant neurological or psychiatric disorders

- Experienced clinically relevant coronary artery disease, myocardial infarction within
6 months prior to randomization, uncontrolled congestive heart failure, or symptomatic
poorly controlled arrhythmia

- Poorly-controlled hypertension

- Experienced any serious Grade 3-4 gastrointestinal bleeding within 3 months prior to
study entry

- Receiving chronic daily treatment with aspirin (> 325 mg/day) or other known
inhibitors of platelet function

- Serious nonhealing wound, ulcer, or bone fracture within 28 days prior to
randomization

- Major surgery within 28 days prior the first dose of study medication, or subcutaneous
venous access device placement within 7 days prior to randomization

- Elective or a planned major surgery

- Pregnant or lactating

- Any other serious uncontrolled medical disorders or psychological conditions

- Allergy / history of hypersensitivity reaction to any of the treatment components

- History of drug abuse
We found this trial at
39
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Spokane Valley, Washington 99216
940
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Alexandria, LA
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Bedford, TX
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Bronx, NY
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1729
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Chicago, IL
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2109
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Christiansburg, VA
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1462
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Columbia, MO
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28
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Corona, CA
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1225
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Dallas, TX
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686
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El Paso, TX
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Fairfax, VA
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Fort Myers, FL
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Fort Worth, TX
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Fountain Valley, California 92708
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5574
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Gent,
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Hilton Head Island, South Carolina 29926
2148
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Hilton Head Island, SC
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1137
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Kerrville, TX
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2387
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Langhorne, PA
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2440
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Latham, NY
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1254
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Lincoln, NE
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Longview, TX
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1813
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Louisville, KY
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McAllen, TX
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Miami, FL
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Midland, TX
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1511
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Minneapolis, MN
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Nashville, TN
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Neptune, NJ
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Paris, TX
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Peoria, IL
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31
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Riverside, CA
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San Antonio, TX
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352
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Scottsdale, AZ
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964
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Seattle, WA
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The Woodlands, TX
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427
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Tucson, AZ
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1315
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Tyler, TX
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1219
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Waco, TX
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