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 |
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.
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
sites
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Hilton Head Island, South Carolina 29926
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