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Phase 3 Completed N=1,253 Randomized Quadruple-blind Treatment

A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy

Source: ClinicalTrials.gov NCT01168973 ↗
Enrolled (actual)
1,253
Serious AEs
45.4%
Results posted
Dec 2014
Primary outcomePrimary: Overall Survival — 10.5; 9.1 months

Summary

The purpose of the study is to compare the survival of participants who receive chemotherapy and ramucirumab versus chemotherapy alone as second line treatment for NSCLC after prior first line platinum-based chemotherapy.

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Survival
10.5; 9.1
SECONDARY
Progression-Free Survival (PFS) Time
4.5; 3.0
SECONDARY
Percentage of Participants Achieving an Objective Response (Objective Response Rate)
22.9; 13.6
SECONDARY
Percentage of Participants Achieving Disease Control (Disease Control Rate)
64.0; 52.6
SECONDARY
Maximum Improvement on Lung Cancer Symptom Scale (LCSS)
-10.9; -11.0; -12.1; -12.0; -13.8; -14.3
SECONDARY
Change From Baseline to 30-Day Follow-Up Visit on European Quality of Life Questionnaire-5 Dimension (EQ-5D) Health State Scores
-0.140; -0.126; -5.9; -6.1
SECONDARY
Maximum and Minimum Serum Concentrations (Cmax and Cmin) of Ramucirumab
262; 28.3; 237; 38.4
SECONDARY
Number of Participants With Anti-Ramucirumab Antibodies
9; 16; 9; 16

Eligibility 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 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 milliliters per minute (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 10^3/microliters (µL), hemoglobin greater than or equal to 10.0 grams/deciliter (g/dL), and platelets greater than or equal to 100 x 10^3/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 milligrams (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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01168973). 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.

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