A Study of Pemetrexed & Carboplatin/Cisplatin or Gemcitabine & Carboplatin/Cisplatin With or Without IMC-1121B in Patients Previously Untreated With Recurrent or Advanced Non-small Cell Lung Cancer (NSCLC)
This study is currently recruiting participants.
Verified March 2013 by ImClone LLC
Sponsor:
ImClone LLC
Information provided by (Responsible Party):
ImClone LLC
ClinicalTrials.gov Identifier:
NCT01160744
First received: July 8, 2010
Last updated: May 15, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to determine if patients with Stage 4 non-small cell lung cancer have a better outcome when treated with 1121B in combination with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin then when treated with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung |
Biological: 1121B (ramucirumab) Drug: Pemetrexed Drug: Carboplatin (AUC 6) Drug: Cisplatin Drug: Gemcitabine Drug: Carboplatin (AUC 5) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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) |
Resource links provided by NLM:
Drug Information available for:
Cisplatin
Carboplatin
Gemcitabine
Gemcitabine hydrochloride
Pemetrexed
Pemetrexed disodium
U.S. FDA Resources
Further study details as provided by ImClone LLC:
Primary Outcome Measures:
- Progression-free survival (PFS) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]Randomization and every 6 weeks (every 2 cycles), to disease progression or recurrence
Secondary Outcome Measures:
- Objective Response Rate (ORR) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]Randomization and every 6 weeks (every 2 cycles), to disease progression or recurrence
- Overall Survival (OS) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]Randomization to the date of death from any cause
- Duration of response [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]Randomization and every 6 weeks (every 2 cycles), until documented response
- Summary Listing of Participants Reporting Treatment-Emergent Adverse Events [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 280 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1121B + Pemetrexed + Carboplatin (AUC 6) or Cisplatin
1121B + Pemetrexed + Carboplatin (AUC 6) or Cisplatin
|
Biological: 1121B (ramucirumab)
10 mg/kg once every 3 weeks beginning Day 1, Cycle 1
Other Names:
Drug: Pemetrexed
500 mg/m2 on Day 1 of every 21-day cycle
Other Name: ALIMTA®
Drug: Carboplatin (AUC 6)
Day 1 of every 21-day cycle
Drug: Cisplatin
75 mg/m2 I.V. on Day 1 of each 21-day cycle
|
|
Active Comparator: Pemetrexed + Carboplatin (AUC 6) or Cisplatin
Pemetrexed + Carboplatin (AUC 6) or Cisplatin
|
Drug: Pemetrexed
500 mg/m2 on Day 1 of every 21-day cycle
Other Name: ALIMTA®
Drug: Carboplatin (AUC 6)
Day 1 of every 21-day cycle
Drug: Cisplatin
75 mg/m2 I.V. on Day 1 of each 21-day cycle
|
|
Experimental: 1121B + Gemcitabine + Carboplatin (AUC 5) or Cisplatin
1121B + Gemcitabine + Carboplatin (AUC 5) or Cisplatin
|
Biological: 1121B (ramucirumab)
10 mg/kg once every 3 weeks beginning Day 1, Cycle 1
Other Names:
Drug: Cisplatin
75 mg/m2 I.V. on Day 1 of each 21-day cycle
Drug: Gemcitabine
1000 mg/m2 on Days 1 and 8 of every 21-day cycle
Drug: Carboplatin (AUC 5)
Day 1 of every 21-day cycle
|
|
Active Comparator: Gemcitabine + Carboplatin (AUC 5) or Cisplatin
Gemcitabine + Carboplatin (AUC 5) or Cisplatin
|
Drug: Cisplatin
75 mg/m2 I.V. on Day 1 of each 21-day cycle
Drug: Gemcitabine
1000 mg/m2 on Days 1 and 8 of every 21-day cycle
Drug: Carboplatin (AUC 5)
Day 1 of every 21-day cycle
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01160744
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Contacts
| Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 |
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| United States, Arizona | |
| 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. | Recruiting |
| Scottsdale, Arizona, United States, 85258 | |
| Contact: ImClone | |
| 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. | Recruiting |
| Tucson, Arizona, United States, 85704 | |
| Contact: ImClone | |
| United States, California | |
| 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. | Recruiting |
| Corona, California, United States, 92879 | |
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| 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. | Recruiting |
| Fountain Valley, California, United States, 92708 | |
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| 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. | Recruiting |
| Riverside, California, United States, 92501 | |
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| 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. | Recruiting |
| Sacramento, California, United States, 95816 | |
| Contact: ImClone | |
| United States, Colorado | |
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| Aurora, Colorado, United States, 80045 | |
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| United States, Florida | |
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| Fort Myers, Florida, United States, 33916 | |
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| Miami, Florida, United States, 33176 | |
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| New Port Richey, Florida, United States, 34655 | |
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| United States, Illinois | |
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| Chicago, Illinois, United States, 60612 | |
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| Peoria, Illinois, United States, 61615 | |
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| United States, Kentucky | |
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| Louisville, Kentucky, United States, 40202 | |
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| United States, Maryland | |
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| Westminister, Maryland, United States, 21157 | |
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| United States, Minnesota | |
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| Minneapolis, Minnesota, United States, 55404 | |
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| United States, Missouri | |
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| Columbia, Missouri, United States, 65201 | |
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| United States, Nebraska | |
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| Lincoln, Nebraska, United States, 68506 | |
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| United States, New Jersey | |
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| Neptune, New Jersey, United States, 07754 | |
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| United States, New York | |
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| Bronx, New York, United States, 10467 | |
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| Latham, New York, United States, 12110 | |
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| New York, New York, United States, 10016 | |
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| United States, Pennsylvania | |
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| Langhorne, Pennsylvania, United States, 19047 | |
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| United States, South Carolina | |
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| Hilton Head Island, South Carolina, United States, 29926 | |
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| United States, Tennessee | |
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| Germantown, Tennessee, United States, 38138 | |
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| Nashville, Tennessee, United States, 37203 | |
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| United States, Texas | |
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| Bedford, Texas, United States, 76022 | |
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| Dallas, Texas, United States, 75231 | |
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| El Paso, Texas, United States, 79915 | |
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| Fort Worth, Texas, United States, 76104 | |
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| Kerrville, Texas, United States, 78028 | |
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| Longview, Texas, United States, 75601 | |
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| Mcallen, Texas, United States, 78503 | |
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| Midland, Texas, United States, 79701 | |
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| Paris, Texas, United States, 75460 | |
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| San Antonio, Texas, United States, 78229 | |
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| The Woodlands, Texas, United States, 77380 | |
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| Tyler, Texas, United States, 75702 | |
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| Waco, Texas, United States, 76712 | |
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| Wichita Falls, Texas, United States, 76310 | |
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| United States, Virginia | |
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| Christiansburg, Virginia, United States, 24073 | |
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| Fairfax, Virginia, United States, 22031 | |
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| United States, Washington | |
| 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. | Recruiting |
| Seattle, Washington, United States, 98133 | |
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| Spokane, Washington, United States, 99216 | |
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| Belgium | |
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| Gent, Belgium, 9000 | |
| Contact: ImClone | |
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| Liège, Belgium, 4000 | |
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| Canada, Ontario | |
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| Toronto, Ontario, Canada, M4N 3M5 | |
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| Canada, Quebec | |
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| Levis, Quebec, Canada, G6V 3Z1 | |
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| Montreal, Quebec, Canada, H2L 4M1 | |
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| Germany | |
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| Berlin, Germany, 14165 | |
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| Erlangen, Germany, 91054 | |
| Contact: ImClone | |
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| Großhansdorf, Germany, 22927 | |
| Contact: ImClone | |
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| Hemer, Germany, 58675 | |
| Contact: ImClone | |
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| Karlsruhe, Germany, 76137 | |
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| Regensburg, Germany, 93053 | |
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| Ulm, Germany, 89081 | |
| Contact: ImClone | |
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| Villingen-Schwenningen, Germany, 78050 | |
| Contact: ImClone | |
| Poland | |
| 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. | Recruiting |
| Gdansk, Poland, 80-952 | |
| Contact: ImClone | |
| 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. | Recruiting |
| Warsaw, Poland, 02-781 | |
| Contact: ImClone | |
| United Kingdom | |
| 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. | Recruiting |
| Bangor, Gwynedo, United Kingdom, LL57 2PW | |
| Contact: ImClone | |
| 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. | Recruiting |
| Nottingham, Nottinghamshire, United Kingdom, NG5 1PB | |
| Contact: ImClone | |
Sponsors and Collaborators
ImClone LLC
Investigators
| Study Director: | 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) | ImClone LLC |
More Information
No publications provided
| Responsible Party: | ImClone LLC |
| ClinicalTrials.gov Identifier: | NCT01160744 History of Changes |
| Other Study ID Numbers: | 13916, I4T-IE-JVBL, CP12-0917, 2009-016784-11 |
| Study First Received: | July 8, 2010 |
| Last Updated: | May 15, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada United Kingdom: Medicines and Healthcare Products Regulatory Agency Belgium: Federal Agency for Medicinal Products and Health Products Poland: Ministry of Health Germany: Paul-Ehrlich-Institut |
Keywords provided by ImClone LLC:
|
Lung neoplasms Lung cancer Non-small Cell Lung Cancer pemetrexed |
ALIMTA® squamous nonsquamous |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Gemcitabine Pemetrexed |
Cisplatin Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 16, 2013