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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01160744
First received: July 8, 2010
Last updated: May 1, 2014
Last verified: May 2014
  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:


Further study details as provided by Eli Lilly and Company:

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
Primary Completion Date: January 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:
  • ramucirumab
  • LY3009806
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:
  • ramucirumab
  • LY3009806
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160744

  Show 53 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
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 1, 2014
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 Eli Lilly and Company:
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
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014