A Study of Tarceva (Erlotinib) to Compare Two Different Doses in in Currently Smoking Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (CURRENTS)
2015년 7월 23일 업데이트: Hoffmann-La Roche
A Prospective, Double-blind Randomized Phase III Study of 300 mg Versus 150 mg Erlotinib in Current Smokers With Locally Advanced or Metastatic NSCLC in Second-line Setting After Failure on Chemotherapy (CURRENTS)
This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib [Tarceva] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy.
Patients must be current smokers and not intending to stop smoking during the study.
Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses.
Treatment will continue until disease progression.
연구 개요
연구 유형
중재적
등록 (실제)
315
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Amsterdam, 네덜란드, 1007 MB
-
Breda, 네덜란드, 4818 CK
-
Nieuwegein, 네덜란드, 3435 CM
-
Zwolle, 네덜란드, 8011 JW
-
-
-
-
-
Hillerod, 덴마크, 3400
-
København, 덴마크, 2100
-
Naestved, 덴마크, 4700
-
Roskilde, 덴마크, 4000
-
-
-
-
-
Berlin, 독일, 13125
-
Berlin, 독일, 14165
-
Essen, 독일, 45122
-
Gauting, 독일, 82131
-
Grosshansdorf, 독일, 22927
-
Hannover, 독일, 30625
-
Hannover, 독일, 30659
-
Immenhausen, 독일, 34376
-
Lostau, 독일, 39291
-
München, 독일, 81925
-
Nürnberg, 독일, 90419
-
Rheine, 독일, 48431
-
Villingen-Schwenningen, 독일, 78052
-
Wuerselen, 독일, 52146
-
Wuppertal, 독일, 42283
-
-
-
-
-
Baden, 스위스, 5404
-
Basel, 스위스, 4031
-
Bern, 스위스, 3011
-
Fribourg, 스위스, 1708
-
-
-
-
-
Barcelona, 스페인, 08035
-
Barcelona, 스페인, 08041
-
Madrid, 스페인, 28040
-
Madrid, 스페인, 28041
-
Malaga, 스페인, 29010
-
Sevilla, 스페인, 41013
-
Valencia, 스페인, 46009
-
-
Barcelona
-
Sabadell, Barcelona, Barcelona, 스페인, 08208
-
-
-
-
-
Cairo, 이집트, 11796
-
Cairo, 이집트
-
-
-
-
-
Beijing, 중국, 100071
-
Changchun, 중국, 130012
-
Chengdu, 중국, 610041
-
Fuzhou, 중국, 350014
-
Guangzhou, 중국, 510030
-
Nanjing, 중국, 210009
-
Nanning, 중국, 530021
-
Shanghai, 중국, 200433
-
Shanghai, 중국, 200030
-
Shenyang, 중국, 110001
-
Tianjin, 중국, 300060
-
Wuhan, 중국, 430030
-
-
-
-
-
Ankara, 칠면조, 06200
-
Ankara, 칠면조, 06000
-
Eskisehir, 칠면조, 26480
-
Gaziantep, 칠면조, 27310
-
Izmir, 칠면조, 35340
-
Izmir, 칠면조, 35110
-
Konya, 칠면조, 42050
-
-
-
-
-
Caen, 프랑스, 14076
-
Limoges, 프랑스, 87042
-
Marseille, 프랑스, 13915
-
Paris, 프랑스, 75014
-
Paris, 프랑스, 75908
-
Paris, 프랑스, 75674
-
Pontoise, 프랑스, 95300
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Adult patients aged ≥18 years
- inoperable, locally advanced (stage IIIB/IV) with supraclavicular lymph node metastases or malignant pleural or pericardial effusion) or metastatic (stage IV) non-small cell lung cancer (NSCLC)
- Disease must be characterized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Patients have received one prior platinum-based chemotherapy regimen for advanced NSCLC, but must have recovered from any treatment-related toxicity
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy ≥12 weeks
- Current cigarette smoker (having smoked >100 cigarettes in entire lifetime and currently smoking on average ≥1 cigarette per day), not intending to stop during the study
Exclusion Criteria:
- Prior antibody or small molecule therapy against Epidermal growth factor receptor (EGFR)
- Radiotherapy within 28 days prior to enrollment
- Received more than one line of chemotherapy for locally advanced/metastatic NSCLC (first-line maintenance chemotherapy after first-line platinum-based chemotherapy is allowed)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Erlotinib 150 mg
Erlotinib 150 mg single daily oral dose until disease progression.
|
Single daily oral dose
다른 이름들:
|
|
실험적: Erlotinib 300 mg
Erlotinib 300 mg single daily oral dose until disease progression.
|
Single daily oral dose
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression-Free Survival (PFS)
기간: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months)
|
PFS is defined as the time from randomization to the date of first occurrence of disease progression or death.
For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions.
For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
|
Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months)
|
|
Progression-Free Survival (PFS) at the End of Study
기간: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
|
PFS is defined as the time from randomization to the date of first occurrence of disease progression or death.
For target lesions, Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions.
For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
|
Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Survival (OS)
기간: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
|
OS defined as the time from randomization to the date of death due to any cause.
|
Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
|
|
Overall Response Rate (ORR)
기간: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
|
Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
A participant was defined as a responder if they sustained a complete response (CR) or partial response (PR) for at least 4 weeks during randomized treatment (confirmed response).
Patients with no tumor assessment after the start of study treatment were to be considered as non-responders.
The percentage of participants in each best response category is presented.
|
Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
|
|
Disease Control Rate (DCR)
기간: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
|
Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans.
Disease control rates were measured according to RECIST version 1.1 criteria.
A participant was defined as having controlled disease if they sustained a Complete Response (CR) or Partial Response (PR) for at least 4 weeks during randomized treatment (confirmed response), or Stable Disease (SD) for at least 6 weeks.
Patients with no tumor assessment after the start of study treatment were considered as having uncontrolled disease.
The percentage of participants with Disease Control is presented.
|
Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
|
|
Time to Progression (TTP)
기간: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
|
Tumor response was assessed by the investigator using computer tomography (CT) or magnetic resonance imaging (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Time to progression (TTP) in weeks was defined as the time from randomization to the date of disease progression.
Participants without event were censored at the date of the last tumor assessment when the patient was known to be progression free.
|
Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 months)
|
|
Number of Participants With Adverse Events (AEs) at the End of the Study
기간: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
|
An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Adverse Events in the following categories are presented: Adverse Events, Serious Adverse Events, AEs leading to withdrawal from treatment and AEs leading to death. |
Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
|
|
Overall Survival (OS) at the End of Study
기간: Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
|
OS defined as the time from randomization to the date of death due to any cause.
|
Randomization to End of Study: 14 October 2010 - 7 February 2014 (Up to 39.8 months)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 10월 1일
기본 완료 (실제)
2013년 10월 1일
연구 완료 (실제)
2014년 2월 1일
연구 등록 날짜
최초 제출
2010년 8월 16일
QC 기준을 충족하는 최초 제출
2010년 8월 16일
처음 게시됨 (추정)
2010년 8월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 8월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 7월 23일
마지막으로 확인됨
2015년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .