Phase 2
Completed N=41
A Study of Ramucirumab (IMC-1121B) With Paclitaxel and Carboplatin in Non-small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00735696 ↗Enrolled (actual)
41
Serious AEs
47.5%
Results posted
Dec 2014
Primary outcomePrimary: Percentage of Participants Who Are Progression-free (PFS) at 6 Months — 59.0 percentage of participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Are Progression-free (PFS) at 6 Months |
59.0 | — |
| SECONDARY Summary of Participants Reporting Adverse Events |
34; 8; 15; 13; 24; 0 | — |
| SECONDARY Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate ([ORR]) |
55.0 | — |
| SECONDARY Duration of Response |
5.54 | — |
| SECONDARY Overall Survival (OS) at 1 Year |
74.6 | — |
| SECONDARY Progression-free Survival (PFS) |
7.85 | — |
| SECONDARY Overall Survival (OS) |
16.85 | — |
| SECONDARY Serum Anti-Ramucirumab Antibody Assessment |
1 | — |
| SECONDARY Maximum Concentration of Ramucirumab (Cmax) |
372 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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
- Peripheral neuropathy ≥ Grade 2 (National Cancer Institute Common Toxicity Criteria for Adverse Events, Version 3.0 [NCI-CTCAE v 3.0])
- If female, is pregnant or lactating
- Radiographic evidence of intratumor cavitation
- Grade 3-4 gastrointestinal bleeding within 3 months prior to study entry
Data sourced from ClinicalTrials.gov (NCT00735696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.