A Study of Chemotherapy and Ramucirumab vs. Chemotherapy Alone in Second Line Non-small Cell Lung Cancer Participants Who Received Prior First Line Platinum Based Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
ImClone LLC
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01168973
First received: July 16, 2010
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

The purpose of the study is to compare survival of participants who receive chemotherapy and ramucirumab vs. chemotherapy alone as second line treatment for non-small cell lung cancer after prior first line platinum based chemotherapy


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: Docetaxel
Biological: Ramucirumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression After One Prior Platinum-Based Therapy

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Baseline to date of death from any cause ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival time [ Time Frame: Baseline to measured progressive disease or date of death from any cause ] [ Designated as safety issue: No ]
  • Proportion of participants achieving an objective response (objective response rate) [ Time Frame: Baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Proportion of participants achieving disease control (Disease Control Rate) [ Time Frame: Baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Maximum Improvement on Lung Cancer Sympton Scale [ Time Frame: Baseline through 30 day follow up visit ] [ Designated as safety issue: Yes ]
  • Change from baseline up to 30 day follow up visit on EuroQol score [ Time Frame: Baseline, 30 day follow up visit ] [ Designated as safety issue: No ]
  • Cmax and Cmin of Ramucirumab [ Time Frame: Baseline, prior to infusion of Cycle 3 and 5, and 30 days following last infusion ] [ Designated as safety issue: No ]
  • Incidence of anti Ramucirumab antibodies [ Time Frame: Baseline, prior to infusion of Cycle 3 and 5, and 30 days following last infusion ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1242
Study Start Date: December 2010
Estimated Study Completion Date: April 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docetaxel + Ramucirumab Drug: Docetaxel
75mg/m2 (60mg/m2 for the countries of Korea and Taiwan only with protocol amendment dated 22May2012) administered intravenously on day 1 of 21 day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met
Biological: Ramucirumab
10mg/kg administered intravenously on day 1 of 21 day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met
Other Names:
  • Ramucirumab
  • IMC 1121B
  • LY3009806
Placebo Comparator: Docetaxel + Placebo Drug: Docetaxel
75mg/m2 (60mg/m2 for the countries of Korea and Taiwan only with protocol amendment dated 22May2012) administered intravenously on day 1 of 21 day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met
Drug: Placebo
Administered intravenously on day 1 of 21 day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Disease progression during or after one prior first-line platinum-based chemotherapy with or without maintenance therapy
  • Prior bevacizumab as first-line and/or maintenance therapy is allowed
  • Signed informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Histologically or cytologically confirmed non small cell lung cancer (NSCLC)
  • Stage IV NSCLC disease
  • Participants have measurable or nonmeasurable disease
  • Adequate organ function, defined as:

    • Total bilirubin less than or equal to Upper Limit of Normal (ULN),
    • Aspartate Aminotransferase (AST) and Alanine Aminotransaminase (ALT) less than or equal to 2.5 x ULN, or less than or equal to 5 x ULN if the transferase elevation is due to liver metastases,
    • Serum creatinine less than or equal to 1.5 x ULN or calculated creatinine clearance greater than or equal to 50 ml/min (per the Cockcroft-Gault formula or equivalent and/or 24-hour urine collection),
    • Absolute Neutrophil Count (ANC) greater than or equal to 1.5 x 103/microliters (µL), hemoglobin greater than or equal to 10.0 grams/deciliter (g/dl), and platelets greater than or equal to 100 x 103/µL,
    • Adequate coagulation function as defined by International Normalized Ratio (INR) less than or equal to 1.5, or prothrombin time and partial thromboplastin time less than or equal to 1.5 x ULN.
    • The participant does not have cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis.
  • Urinary protein is less than or equal to 1+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria greater than or equal to 2+, a 24-hour urine must be collected and must demonstrate less than 1000 mg of protein
  • Participants of reproductive potential (both sexes) must agree to use reliable method of birth control (hormonal or barrier methods) during the study period and at least 12 weeks after the last dose of study therapy
  • Life expectancy of greater than or equal to 3 months
  • Prior radiation therapy is allowed if: In the case of chest radiotherapy at least 28 days have elapsed from the completion of radiation treatment prior to randomization; In the case of focal or palliative radiation treatment at least 7 days have elapsed from last radiation treatment prior to randomization (and provided that 25% or less of total bone marrow had been irradiated); In the case of Central Nervous System (CNS) radiation at least 14 days have elapsed from the completion of radiation treatment prior to randomization

Exclusion Criteria:

  • Disease progression on more than 1 prior chemotherapy regimens
  • Participants whose only prior treatment was a tyrosine kinase inhibitor
  • The participant's tumor wholly or partially contains small cell lung cancer
  • Major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization. Postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months
  • Concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, chemoembolization, or targeted therapy
  • Last dose of bevacizumab must be at least 28 days from time of randomization
  • Last dose of cytotoxic chemotherapy must be at least 14 days from time of randomization
  • The participant has untreated CNS metastases. Participants with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation ending at least 2 weeks prior to randomization, or after surgical resection performed at least 28 days prior to randomization. No evidence of Grade greater than or equal to 1 CNS hemorrhage based on pretreatment Magnetic Resonance Imaging (MRI) or intravenous (IV) contrast CT scan
  • Radiologically documented evidence of major blood vessel invasion or encasement by cancer
  • Radiographic evidence of intratumor cavitation
  • History of uncontrolled hereditary or acquired thrombotic disorder
  • Chronic therapy with nonsteroidal anti-inflammatory drug (NSAIDs) or other antiplatelet agents; Aspirin use at doses up to 325 mg/day is permitted
  • History of gross hemoptysis (defined as bright red blood or greater than or equal to 1/2 teaspoon) within 2 months prior to randomization
  • Clinically relevant congestive heart failure (New York Heart Association [NYHA II-IV]) or symptomatic or poorly controlled cardiac arrhythmia
  • Any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization
  • Uncontrolled arterial hypertension greater than or equal to 150 / greater than or equal to 90 mm Hg despite standard medical management
  • Serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
  • Significant bleeding disorders, vasculitis, or Grade 3/4 gastrointestinal bleeding within 3 months prior to randomization
  • Gastrointestinal (GI) perforation and/or fistulae within 6 months prior to randomization
  • Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection Crohn's disease, ulcerative colitis, or chronic diarrhea
  • Peripheral neuropathy greater than or equal to Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 4.02)
  • Serious illness or medical condition(s) including, but not limited to: Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness; Active or uncontrolled clinically serious infection; Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration
  • Known allergy or hypersensitivity reaction to any of the treatment components
  • The participant is pregnant or breastfeeding
  • Current or recent (within 28 days prior to randomization) treatment with an investigational drug or device that has not received regulatory approval for any indication at the time of randomization, or participation in another interventional clinical trial
  • Prior therapy with docetaxel
  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: NCT01168973

  Show 231 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
ImClone LLC
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01168973     History of Changes
Other Study ID Numbers: 13852, I4T-MC-JVBA, 2010-021297-11, CP12-1027, CTRI/2011/08/001942
Study First Received: July 16, 2010
Last Updated: May 1, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Austria: Federal Office for Safety in Health Care
Canada: Health Canada
France: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
India: Drugs Controller General of India
Israel: Ministry of Health
Italy: Ethics Committee
Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Mexico: Secretaria de Salud
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: The Central Register of Clinical Trials
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
Taiwan: Department of Health
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
second line
non small cell lung cancer
NSCLC
phase 3
ramucirumab
lung cancer
docetaxel
taxotere

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014