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临床试验/NCT03718117
NCT03718117已完成不适用

CHARACTERISTICS OF ADULT PATIENTS TREATED WITH CRIZOTINIB FOR ADVANCED NON-SMALL-CELL LUNG CANCER (NSCLC) WITH ALK GENE REARRANGEMENT OR ROS1 GENE REARRANGEMENT IN GENERAL HOSPITALS.

Pfizer26 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2017年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Pfizer
入组人数
71
试验地点
26
主要终点
Age: Line of Treatment

研究概览

简要总结

Descriptive Observational Study.

Characteristics Of ALK-positive and ROS1-positive Adults Patients Non-Small Cell Lung Cancer (NSCLC) Treated With Crizotinib Within General Hospitals

详细描述

Describe the characteristics of patients treated with crizotinib Describe efficacy, safety, observance and QoL.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Age: Line of Treatment

时间窗: Baseline

Body Weight: Line of Treatment and Gene Rearrangement

时间窗: Baseline

Body weight in kilograms (kg) measured at baseline were reported.

Body Mass Index (BMI): Line of Treatment and Gene Rearrangement

时间窗: Baseline

BMI was obtained by dividing body weight in kilograms (kg) by height in meters square (m\^2).

Gender: Line of Treatment

时间窗: Baseline

Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement

时间窗: Baseline

Number of participants were classified according to smoking status as non-smoker, ex-smoker (did not smoke in at least 1 year prior to baseline) and current-smoker.

Number of Pack Years: Line of Treatment and Gene Rearrangement

时间窗: Baseline

The number of pack-years was calculated at baseline for ex-smokers and current smokers by multiplying the number of packs they consumed per day and the number of years that the participant had smoked this quantity of packs. Combined data is reported for ex-smokers and current smokers.

Duration of Smoking and Duration of Quitting Smoke: Line of Treatment and Gene Rearrangement

时间窗: Baseline

Duration of smoking: a) for ex-smokers, duration of smoking (years) was calculated by subtracting start year with year of smoking stop, b) for current smokers, duration of smoking (years) was calculated by subtracting start year with year of Inclusion visit date. Combined data of duration of smoking is reported for ex-smokers and current smokers. Duration of quitting smoke (years) for ex-smokers was calculated by subtracting year of smoking stop with year of inclusion visit date.

Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Assessment: Line of Treatment and Gene Rearrangement

时间窗: Baseline

Number of participants were categorized as yes or no, according to have undergone assessment with ECOG performance status. ECOG performance status was used to measure quality of life of oncology participants with scores running from 0 (no severity) to 5 (maximum severity); where 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity, ambulatory, able to carry out light or sedentary work; 2= ambulatory, capable of all self-care, unable to carry out any work activity, up greater than (\>) 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed or chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead.

Number of Participants Categorized According to ECOG Performance Status Scores: Line of Treatment and Gene Rearrangement

时间窗: Baseline

ECOG performance status was used to measure quality of life of oncology patients with scores running from 0 (no severity) to 5 (maximum severity); where 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity, ambulatory, able to carry out light or sedentary work; 2= ambulatory, capable of all self-care, unable to carry out any work activity, up \>50% of waking hours; 3= capable of only limited self-care, confined to bed or chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead. Participants were categorized according to ECOG performance status scores of 0-1 and \>=2.

Time Since Diagnosis of NSCLC: Treatment and Gene Rearrangement

时间窗: Baseline

Time since diagnosis of NSCLC (months) was calculated as: inclusion visit date minus date of the biopsy that enabled making the diagnosis divided by 365.35/12. If the day of the diagnosis was missing, it was replaced by the 15th of the month for calculation.

Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement

时间窗: Baseline

Participants were categorized according to type of tumor's histology as adenocarcinoma, carcinoma indifferencier and other.

Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement

时间窗: Baseline

Participants were categorized according to tumor stage as IIIA/B or IVA/B classified as per Tumor Node Metastasis (TNM), 8th edition. TNM: based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant (other parts of body) metastasis. Stages included: stage 0 (no evidence of cancer cells), stage l (T1N0M0), stage IIA (T0N1M0, T1N1M0, T2N0M0), stage IIB (T2N1M0, T3N0M0), stage IIIA (T0N2M0, T1N2M0, T2N3M0, T3N1 or N2M0), stage IIIb (T4 any NM0, any TN3M0), stage IIIC (any TN3M0), stage IV (any T any NM1), where T0= early form of tumor, T1=\<2 centimeter (cm), T2 =2-5 cm, T3=\>2 cm, T4=large sized, N0= not spread to LN, N1= spread to 1 to 3, N2= spread to 4 to 9, N3= spread \>10 axillary LN, M0= no metastasis, M1= metastasis. Tumor stage categories with at least 1 participant in any reporting arm are reported.

Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement

时间窗: Baseline

Participants were categorized according to location of tumor: upper right lobe, upper left lobe, middle right lobe, lower right lobe, and lower left lobe.

Number of Participants Categorized According to Presence of Metastases: Line of Treatment and Gene Rearrangement

时间窗: Baseline

Participants were categorized according to presence of metastases as Yes or No.

Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement

时间窗: Baseline

Participants were categorized according to number of metastatic sites.

Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement

时间窗: Baseline

Participants were categorized according to the location of metastases. Participant could have more than 1 location of metastases.

Time Since the First Strategy Start to Crizotinib Initiation: Line of Treatment and Gene Rearrangement

时间窗: Baseline

Time since the first strategy start to crizotinib initiation (months) was calculated as: crizotinib initiation date minus start date of the first strategy divided by 365.35/12. If the start date was missing, it was replaced by the 15th of the month for calculation.

Number of Participants Categorized as "Yes" or "No" for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement

时间窗: Baseline

Number of participants were categorized according to the different lines of chemotherapy.

Number of Cycles for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement

时间窗: Baseline

In this outcome measure, median of number of cycles for different lines of chemotherapy were reported.

Duration of Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement

时间窗: Baseline

In this outcome measure, median duration of different lines of chemotherapy was reported. Duration of chemotherapy (months) was calculated as = End date of the last cycle minus start date of the first cycle plus 1 divided by 365.25/12. If the day of the date was missing, it was replaced by the 15th of the month. If the month of the date was missing, the duration was considered as missing.

Number of Participants Categorized as "Yes" or "No" for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement

时间窗: Baseline

In this outcome measure, participants were categorized according to the previous treatments received. Participant could have received more than 1 type of previous therapies.

Dose of Previous Brain Irradiation and Radiotherapies: Line of Treatment and Gene Rearrangement

时间窗: Baseline

In this outcome measure, median of dose of brain irradiation and radiotherapies were reported.

Duration of Previous Brain Irradiation Therapy and Radiotherapies: Line of Treatment and Gene Rearrangement

时间窗: Baseline

In this outcome measure, duration of previous brain irradiation therapy and radiotherapies was reported.

次要结局

  • Number of Participants Categorized According to Diagnostic Method to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement(Baseline)
  • Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement(Baseline)
  • Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement(Baseline)
  • Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement(Baseline)
  • Duration Between Sending and Receipt of ALK and ROS1 Results: Line of Treatment and Gene Rearrangement(Baseline)
  • Number of Participants Among Whom Search for Other Biological Markers Was Carried Out: Line of Treatment and Gene Rearrangement(Baseline)
  • Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18(Month 3, 6, 9, 12, 15 and 18)
  • Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18(Month 3, 6, 9, 12, 15 and 18)
  • Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18(Month 3, 6, 9, 12, 15 and 18)
  • Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18(Month 3, 6, 9, 12, 15 and 18)
  • Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18(Month 3, 6, 9, 12, 15 and 18)
  • Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18(Month 3, 6, 9, 12, 15 and 18)
  • Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18(Month 3, 6, 9, 12, 15 and 18)
  • Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18(Month 3, 6, 9, 12, 15 and 18)
  • Treatment Duration Until Progression With Brain Metastases(Baseline)
  • Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18(Month 3, 6, 9, 12, 15 and 18)
  • Objective Response Rate (ORR)(Maximum up to 18 months)
  • Disease Control Rate (DCR) at Month 12 and 18(Month 12, 18)
  • European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18(Baseline, Month 3, 6, 9, 12, 15, 18)
  • Time to Median Progression Free Survival (Months) With Its 95%CI(18 months)
  • 18-Month Overall Survival (OS) Rate (95%CI)(18 months)
  • Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18(Month 3, 6, 9, 12, 15 and 18)
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to maximum of 18 months)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (26)

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