A Study of Ramucirumab (IMC-1121B) With Paclitaxel and Carboplatin in Non-small Cell Lung Cancer

NCT00735696 | Completed Phase 2 Results DMC

• 4 other identifiers: 139142007-006715-22CP12-0708I4T-IE-JVBJ
• Study Type: interventional
• Target: 41
• Locations: 2 countries
• Sites: 9

Brief Summary

The purpose of this study is to evaluate the progression-free survival (PFS) rate at 6 months of ramucirumab administered in combination with paclitaxel and carboplatin as first-line therapy for Stage IIIB or IV non-small cell lung cancer

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer; Lung; NSCLC

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Are Progression-free (PFS) at 6 Months

  Data presented are the percentage of participants without disease progression or death at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive disease was defined as having at least a 20% increase in sum of longest diameter of target lesions or the appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.

  6 months

Secondary Outcomes (8)

• Summary of Participants Reporting Adverse Events

  Baseline up to 32.5 months

• Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate ([ORR])

  First dose to measured progressive disease or death due to any cause up to 32.5 months

• Duration of Response

  First dose up to 32.5 months

• Overall Survival (OS) at 1 Year

  First dose to 1 year

• Progression-free Survival (PFS)

  First dose to measured progressive disease or death due to any cause, up to 32.5 months

Study Arms (1)

ramucirumab + paclitaxel + carboplatin

EXPERIMENTAL

Participants will receive ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants will continue to receive ramucirumab monotherapy every 3 weeks, provided there is ongoing evidence of benefit upon review every 6 weeks.

Biological: Ramucirumab; Drug: Paclitaxel; Drug: Carboplatin

Interventions

Ramucirumab BIOLOGICAL

10 milligrams per kilogram (mg/kg), intravenous (IV) infusion, on Day 1 of each 21-day cycle.

Also known as: IMC-1121B, LY3009806

ramucirumab + paclitaxel + carboplatin

Paclitaxel DRUG

200 milligrams per meter squared (mg/m\^2), administered intravenously (IV) following the ramucirumab infusion, on day 1 of each 21-day cycle, for up to six cycles.

ramucirumab + paclitaxel + carboplatin

Carboplatin DRUG

Administered after paclitaxel, as an intravenous infusion (IV), over 30 minutes on day 1 of each 21-day cycle, for up to six cycles. The dose to be administered is calculated based on the participant's actual body weight at time of treatment and the area under the curve (AUC) dosing. The target AUC for carboplatin treatment is AUC=6.

ramucirumab + paclitaxel + carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed NSCLC
• Advanced NSCLC
• Measurable disease (as defined by Response Evaluation Criteria in Solid Tumors \[RECIST 1.0\])
• Eastern Cooperative Oncology Group (ECOG) Performance Status is ≤ 1
• Age ≥ 18 years
• Adequate hematologic function = an absolute neutrophil count (ANC) ≥ 1500/μL, hemoglobin ≥ 9 g/dL, and a platelet count ≥ 100,000/microliter (μL)
• Adequate hepatic function = a total bilirubin ≤ 1.5 mg/dL transaminases and alkaline phosphatase ≤ 5 x the upper limit of normal (ULN)
• Adequate renal function serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance (CrCl) \> 60 mL/minute, and urine dipstick for protein \< 1+ (ie, either 0 or trace)
• Adequate coagulation function, INR ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5 seconds above ULN
• Adequate contraception
• Signed informed consent

You may not qualify if:

• Untreated CNS metastases
• Prior bevacizumab therapy
• Radiologically documented evidence of major blood vessel invasion or encasement by cancer
• Prior systemic chemotherapy for Stage IIIB/IV NSCLC
• Prior systemic chemotherapy or radiation therapy for Stage I-IIIA NSCLC \< 1 year prior
• Any concurrent malignancy other than basal cell skin cancer, or carcinoma in situ of the cervix
• Concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or targeted therapy
• Ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Uncontrolled thrombotic or hemorrhagic disorders
• Poorly-controlled hypertension
• Chronic daily treatment with aspirin (\> 325 mg/day) or other known inhibitors of platelet function
• History of gross hemoptysis (defined as bright red blood or ≥ 1/2 teaspoon)
• Serious non-healing wound, ulcer, or bone fracture
• Undergone major surgery or subcutaneous venous access device placement. Post-operative bleeding complications or wound complications from a surgical procedures performed in the last 2 months
• Elective or a planned major surgery to be performed during the course of the trial

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (9)

ImClone Investigational Site

Beverly Hills, California, 90211, United States

Location

ImClone Investigational Site

San Francisco, California, 94143, United States

Location

ImClone Investigational Site

Aurora, Colorado, 80045, United States

Location

ImClone Investigational Site

New York, New York, 10016, United States

Location

ImClone Investigational Site

The Bronx, New York, 10467, United States

Location

ImClone Investigational Site

San Antonio, Texas, 78229, United States

Location

ImClone Investigational Site

Seattle, Washington, 98104, United States

Location

ImClone Investigational Site

Cambridge, United Kingdom

Location

ImClone Investigational Site

London, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Ramucirumab; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2008
• First Posted: August 15, 2008
• Study Start: January 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: January 1, 2012
• Last Updated: December 29, 2014
• Results First Posted: December 29, 2014

Record last verified: 2014-12

Locations

US (7); GB (2)