A Randomized Multicenter Phase III Study of Taxane/Carboplatin/Cetuximab Versus Taxane/Carboplatin as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 755
- 试验地点
- 1
- 主要终点
- Median Number of Months of Progression-free Survival (PFS)
研究概览
简要总结
The primary purpose of this clinical research study is to learn if patients treated with the combination of Taxane/Carboplatin plus Cetuximab (C/T/C) have a longer progression-free survival than patients treated with Taxane/Carboplatin (T/C) alone. The safety of this treatment will also be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy.
- •Tumor/disease lesions that can be measured bidimensionally.
- •Must be able to carry-out work of light or sedentary nature (e.g. light house work, office work).
- •Adequate recovery from recent surgery or radiation therapy.
- •Must be at least 4 weeks from last major surgery or prior treatment with an investigational agent. At least 12 weeks from any radiation therapy to chest.
- •Accessible for treatment, follow-up and required visits at a participating center(s).
排除标准
- •Prior chemotherapy or adjuvant chemotherapy for the treatment of lung cancer.
- •Prior treatment with cetuximab or other epidermal growth factor (EGFR)-targeted therapy.
- •Prior severe infusion reaction to antibody therapy.
- •Concurrent malignancy (previous malignancy without evidence of disease for 5 years will be allowed to enter trial).
- •Concurrent chemotherapy or therapy with another investigational agent not indicated in the protocol.
- •Serious uncontrolled medical disorders that would impair the ability to receive therapy.
- •History of myocardial infarction within prior 3 months, uncontrolled angina, uncontrolled arrhythmia, or uncontrolled congestive heart failure.
- •Symptomatic or uncontrolled metastases in the central nervous system. Subjects receiving a glucocorticoid for central nervous system (CNS) metastases are not eligible, but those receiving an anticonvulsant are eligible.
- •Peripheral neuropathy >= grade 2 (Common Toxicity Criteria Adverse Event [CTCAE] Version 3.0).
- •Inadequate hematologic and/or liver and/or kidney function.
- •Sexually active and fertile individuals or partners of these individuals who are unwilling or unable to use an acceptable method of birth control for entire trial and up to 4 weeks after the study.
- •Women who are pregnant or breastfeeding.
- •Women with a positive pregnancy test on enrollment prior to study drug administration.
- •Altered mental status or psychiatric condition that prohibits understanding or rendering of consent.
研究组 & 干预措施
Cetuximab+Taxane+Carboplatin (C/T/C)
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 intravenous (IV) infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
干预措施: Paclitaxel (Taxane) (Drug)
Cetuximab+Taxane+Carboplatin (C/T/C)
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 intravenous (IV) infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
干预措施: Docetaxel (Taxane) (Drug)
Cetuximab+Taxane+Carboplatin (C/T/C)
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 intravenous (IV) infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
干预措施: Carboplatin (Drug)
Cetuximab+Taxane+Carboplatin (C/T/C)
Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 intravenous (IV) infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
干预措施: Cetuximab (Drug)
Taxane+Carboplatin (T/C)
A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
干预措施: Paclitaxel (Taxane) (Drug)
Taxane+Carboplatin (T/C)
A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
干预措施: Docetaxel (Taxane) (Drug)
Taxane+Carboplatin (T/C)
A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Median Number of Months of Progression-free Survival (PFS)
时间窗: From randomization to evidence of disease progression/death or date of last tumor assessment (up to 26 months).
Interval between randomization date \& earliest date of disease progression/death due to any cause, assessed by the Independent Radiology Review Committee (IRRC) using modified World Health Organization (WHO) criteria to define progressive disease (PD): \>=25% increase in sum of products of diameters (SOPD) of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion. If no progression/death, date of last tumor assessment used. For participants who had no on-study tumor assessments \& were still alive, date of randomization used.
次要结局
- Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD)(From randomization to end of study drug therapy (up to 174 weeks).)
- Median Number of Months of Survival(From randomization to death or date of last contact (up to 41 months).)
- Number of Participants Experiencing Other Significant AEs: Infusion Reaction(From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).)
- Number of Participants Who Exprienced the Most Frequent Grade 3-4 Hematology Abnormalities Occurring in >=5% Participants(From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).)
- Number of Participants With Complete Response (CR) or Partial Response (PR)(From randomization to end of study drug therapy (up to 174 weeks).)
- Median Number of Months Until Symptomatic Progression (Worsening of Symptoms)(From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).)
- Number of Participants Who Died, or Experienced Other Serious Adverse Events (SAEs) and Adverse Events (AEs)(From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).)
- Median Number of Months of Response(Time from first occurrence of CR or PR (whichever was recorded first) to the date of PD, death or date of last tumor assessment (up to 19 months).)
- Number of Participants Who Experienced the Most Frequent Grade 3-4 Serum Chemistry Abnormalities Occurring in >=5% Participants(From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).)
- Median Number of Months to Response(Time from first dose of study therapy to the date of PR or CR, whichever occurred first (up to 13 months).)
- Number of Participants Who Had Unscheduled Visits to Physicians, Clinics, Hospitals and Other Unscheduled Major Medicinal Procedures(Day 1 of each cycle of treatment, at the end of study therapy evaluation and at the first follow-up visit (6 weeks after the end of study therapy evaluation).)
- Number of Participants Experiencing AEs Leading to Study Drug Discontinuation(From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).)
- Number of Participants With Improvement of Symptoms(From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).)
- Number of Participants Experiencing Other Significant AEs: Acneform Rash(From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).)
- Number of Participants Experiencing Other Significant AEs: Cardiac AEs(From start of study drug therapy up to 30 days after the last dose (up to 178 weeks).)