A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression
2015년 3월 24일 업데이트: Hoffmann-La Roche
A Multi-centre, Open-label, Phase IV, Interventional Study to Evaluate the Efficacy of Erlotinib (Tarceva®) Following 4 Cycles of Platinum-based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Experienced Disease Progression or Unacceptable Toxicity During Chemotherapy
This open-label, single-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer who have completed 4 cycles of standard platinum-based chemotherapy without progression.
Patients will receive Tarceva at a dose of 150 mg orally daily until disease progression or unacceptable toxicity occurs.
연구 개요
연구 유형
중재적
등록 (실제)
51
단계
- 4단계
연락처 및 위치
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연구 장소
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Bangalore, 인도, 560027
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Chennai, 인도, 600035
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Delhi, 인도, 110085
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Hyderabad, 인도, 500 034
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Jaipur, 인도, 302 017
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Kolkata, 인도, 700026
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Nasik, 인도, 422005
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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 ≥ 18 years of age.
- Histologically documented non-small cell lung cancer (NSCLC).
- Locally advanced or recurrent (Stage IIIB) or metastatic (Stage IV) disease.
- Completion of 4 cycles of an acceptable, standard, platinum-based chemotherapy doublet without progression.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patients of reproductive potential must agree to use effective contraception.
Exclusion Criteria:
- Prior exposure to agents directed at the human epidermal growth factor receptor (HER) axis (eg, gefitinib, cetuximab, trastuzumab).
- Prior treatment with any monoclonal antibody therapy.
- Any other malignancies within the previous 5 years, except for adequately treated carcinoma in situ of the cervix or squamous cell skin cancer.
- Clinically significant cardiovascular, hepatic, renal, or metabolic disease or active infection
- Pre-existing interstitial lung disease.
- Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
- Pregnant or lactating women.
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: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Erlotinib
Participants received erlotinib 150 mg orally once a day for 48 weeks.
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Erlotinib was supplied as tablets.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants With Progression-free Survival at Week 52
기간: From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months).
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A participant had progression-free survival if they did not have disease progression and were alive.
Tumor assessments were done by magnetic resonance imaging according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions.
All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline.
Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically).
A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
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From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Progression-free Survival (PFS)
기간: From the date of enrolment until the end of the study (up to 2 years, 6 months).
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PFS was defined as the time from the date of enrolment to the date of disease progression (PD) or death, whichever occurred first.
Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.
PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions (TL), taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-TLs.
All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as TLs at Baseline.
TLs should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically).
A sum of the longest diameter for all TLs will be calculated and reported as the Baseline sum longest diameter.
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From the date of enrolment until the end of the study (up to 2 years, 6 months).
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Overall Survival
기간: From the date of enrolment until the end of the study (up to 2 years, 6 months).
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Overall survival was defined as the time from the date of enrolment to the date of death from any cause.
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From the date of enrolment until the end of the study (up to 2 years, 6 months).
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Percentage of Participants With a Complete Response (CR) or a Partial Response (PR)
기간: From the date of enrolment until the end of the study (up to 2 years, 6 months).
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A CR was defined as the disappearance of all target lesions.
A PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter.
All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline.
All other lesions (or sites of disease) should be identified as non-target lesions.
Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically).
A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.
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From the date of enrolment until the end of the study (up to 2 years, 6 months).
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Percentage of Participants With Disease Control
기간: From the date of enrolment until the end of the study (up to 2 years, 6 months).
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A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1.
A CR was defined as the disappearance of all target lesions (TL).
A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD).
SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started.
For non-TLs, SD was defined as the persistence of 1 or more lesions.
PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs.
A SLD for all TLs will be calculated and reported as the Baseline SLD.
Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.
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From the date of enrolment until the end of the study (up to 2 years, 6 months).
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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
2011년 3월 1일
기본 완료 (실제)
2013년 9월 1일
연구 완료 (실제)
2013년 9월 1일
연구 등록 날짜
최초 제출
2010년 10월 28일
QC 기준을 충족하는 최초 제출
2010년 10월 28일
처음 게시됨 (추정)
2010년 10월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 3월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 3월 24일
마지막으로 확인됨
2015년 3월 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. .