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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

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)


Inclusion Criteria:



- Confirmed Non-small Cell Lung Cancer

- 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 postmenopausal, 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 patients 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 patient 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 VEGF or VEGFR

- Receiving concurrent treatment with other anticancer therapy

- Has received previous chemotherapy for Stage IV NSCLC (patients 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 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival (PFS)

Outcome Description:

Randomization and every 6 weeks (every 2 cycles), to disease progression or recurrence

Outcome Time Frame:

up to 24 months

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

13916

NCT ID:

NCT01160744

Start Date:

September 2010

Completion Date:

November 2015

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Lung neoplasms
  • Lung cancer
  • Non-small Cell Lung Cancer
  • pemetrexed
  • ALIMTA®
  • squamous
  • nonsquamous
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Denver, Colorado  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Manhassaet, New York  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Phoenix, Arizona  85012
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Greenbrae, California  94904
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Jacksonville, Florida  32256
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Chicago, Illinois  60674
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Bethesda, Maryland  20817
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Minneapolis, Minnesota  55404
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.St Joseph, Missouri  64507
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Cherry Hill, New Jersey  08003
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Dunmore, Pennsylvania  18512
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Greenville, South Carolina  29605
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Memphis, Tennessee  38138
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Bedford, Texas  76022
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Norfolk, Virginia  23502
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Seattle, Washington  98133
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Omaha, Nebraska  68114
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Lexington, Kentucky  40536