- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02066038
Intermittent and Maintenance of Erlotinib in Combination With Pemetrexed/Carboplatin in Ⅲb/IV Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
A Multi-center, Open-labeled Phase 2 Study of First Line Intermittent and Maintenance of Erlotinib in Combination With Pemetrexed/Carboplatin in ⅢB/IV Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
EGFR-tyrosine kinase inhibitor(TKI)- ie, erlotinib, gefitinib, has been recommended as the first option for EGFR-mutated IIIb/IV NSCLC by serial trials as it prolonged patients' progression-free survival. The OPTIMAl trial indicated that those who received TKI and chemotherapy during the whole treatment window survived longest. Unfortunately, previous studies(INTACT, TRIBUTE et al) that concurrently combined TKI and cytotoxic regimens failed to improve survival in unselected patients. To avoid the potential synergistic antagonism, the FAST-ACT II trial committed a sequential strategy and find a superiority in the combination arm upon chemotherapy even in EGFR-mutated group. However, pharmaceutically, the continuous administration of an EGFR-TKI before subsequent chemotherapy in FAST-ACT II could obviate the effects of cytotoxic agents due to the erlotinib-induced G1 arrest.
On the basis of these and other studies, the investigators hypothesized that a better sequential combination strategy of EGFR-TKI and chemotherapy (adding a EGFR-TKI wash-out window before chemotherapy) would be more efficacious than chemotherapy alone. In this study, the investigators investigate the efficacy(PFS:progression free survival), safety, and adverse-event profile of chemotherapy plus intermittent and maintenance of erlotinib, when these drugs were used as first-line treatment in who had non-squamous lung carcinoma with EGFR gene mutation in China.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients between 18 and 75 years of age.
- Present with histologically proven or cytological diagnosis of non-Squamous NSCLC Stage IIIB or IV as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer, that is not amenable to curative therapy,such as surgery or radiotherapy and so on.
- No prior systemic chemotherapy or targeted therapy for lung cancer before screening.
- Confirmed activating mutation of EGFR-ie, an exon 19 deletion or an exon 21 L858R point mutation.
- Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1.
- Adequate organ function.
- Prior radiation therapy allowed to <25% of the bone marrow . Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 4 weeks before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.
- Signed informed consent document on file.
- Estimated life expectancy of ≥12 weeks.
- Patient compliance and geographic proximity that allow adequate follow up.
Exclusion Criteria:
- Known severe hypersensitivity to erlotinib.
- Patients with uncontrolled brain metastasis.
- Pleural effusion or pericardiac effusion that cannot be controlled by drainage or other procedures.
- Inability to comply with protocol or study procedures.
- A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
- A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Interstitial pneumonia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Pemetrexed 500mg/m2+Carboplatin area under curve(AUC)=5, every 3 weeks, maximum 4 cycles, Erlotinib 150mg/d every cycle d2-15, and Erlotinib 150mg/d from the last cycle until disease progression
|
150mg po on days 2-15 of each 3 week cycle for 4 cycles and 150mg po per day after 4 cycles until disease progression
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Evaluation Criteria in Solid Tumors(RECIST) 1.1
Time Frame: eight weeks
|
Patients were imaged with computed tomography (CT) scan
|
eight weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hao Long, Prof, Sun Yat-sen University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
Other Study ID Numbers
- 2013-FXY-025
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lung, Carcinoma
-
National Cancer Institute (NCI)CompletedLung Adenocarcinoma | Recurrent Non-Small Cell Lung Carcinoma | Adenosquamous Lung Carcinoma | Bronchioloalveolar Carcinoma | Large Cell Lung Carcinoma | Squamous Cell Lung CarcinomaUnited States
-
Ohio State University Comprehensive Cancer CenterNational Institute on Aging (NIA)RecruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Extensive Stage Lung Small Cell Carcinoma | Unresectable Lung Non-Small Cell Carcinoma | Advanced Lung Non-Small Cell Carcinoma | Advanced... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedCarcinoma, Non-Small Cell Lung | Carcinoma, Small-Cell LungUnited States
-
Ohio State University Comprehensive Cancer CenterNational Institute on Aging (NIA)CompletedStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Advanced Lung Carcinoma | Stage IV Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Extensive Stage Lung Small Cell Carcinoma | Unresectable Lung Non-Small Cell Carcinoma | Unresectable Lung CarcinomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI); Society of Thoracic RadiologyActive, not recruitingStage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
Xcovery Holding Company, LLCNot yet recruitingNon-small Cell Lung Carcinoma
-
European Lung Cancer Working PartyCompletedNon Small Cell Lung CarcinomaBelgium
-
Maastricht Radiation OncologyCompletedNon-Small-Cell Lung CarcinomaNetherlands
-
University of LouisvilleJames Graham Brown Cancer CenterCompletedCarcinoma, Non-Small Cell Lung | Carcinoma, Small Cell LungUnited States
-
Pathway GenomicsTerminatedLung Neoplasms | Lung Cancer | Adenocarcinoma of the Lung | Cancer of the Lung | Small Cell Carcinoma of the Lung | Non Small Cell Carcinoma of the LungUnited States
Clinical Trials on Erlotinib
-
National Cancer Institute (NCI)University of Chicago; City of Hope Medical Center; University of Southern California and other collaboratorsCompleted
-
PfizerCompletedCarcinoma, Non-Small-Cell LungUnited States
-
Fox Chase Cancer CenterMillennium Pharmaceuticals, Inc.TerminatedNon-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer RecurrentUnited States
-
AVEO Pharmaceuticals, Inc.Biodesix, Inc.TerminatedNon-small Cell Lung CancerKorea, Republic of, United States, Australia, Taiwan, Singapore, Hong Kong, Italy
-
M.D. Anderson Cancer CenterCompletedAdvanced CancersUnited States
-
Kyowa Kirin Co., Ltd.TerminatedNon-small-cell Lung CancerJapan
-
Merck Sharp & Dohme LLCCompleted
-
University of ChicagoNational Cancer Institute (NCI)CompletedMalignant Peritoneal MesotheliomaUnited States
-
Grupo de Investigación Clínica en Oncología RadioterapiaCompletedSquamous Cell Carcinoma of the Head and NeckSpain
-
New Mexico Cancer Care AllianceCompletedAdvanced Solid Tumor MalignanciesUnited States