Back to resultsChemotherapy and Erlotinib for Lung Cancer With Low Abundance Epidermal Growth Factor Receptor Mutation (INNOVATE)
Primary Purpose
Non-small-cell Lung Cancer
Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Intercalated combination of chemotherapy and erlotinib
Sponsored by
About this trial
This is an interventional treatment trial for Non-small-cell Lung Cancer focused on measuring non-small cell lung cancer, erlotinib, chemotherapy
Eligibility Criteria
Inclusion Criteria:Patients with histologically documented, locally advanced or recurrent (stage IIIb and not amenable to combined modality treatment) or metastatic (stage IV) non-small cell lung cancer.
Low abundant activating EGFR mutation: EGFR exon 19 deletion or exon 21 L858R, which are positive by real-time PCR methods and negative by standard sequencing methods.
Uncommon EGFR mutations are included excluding exon 20 mutations. ECOG performance status of ≤ 2. Patients can administer first line setting of platinum based chemotherapy. Patients must have measurable disease according to the RECIST (version 1.1) criteria.
- Life expectancy of at least 12 weeks.
- Age ≥ 18 years.
- Written (signed) informed Consent to participate in the study.
- Adequate organ function as defined by the following criteria:
Liver function: SGOT (AST) and SGPT (ALT) ≤ 2.5 X ULN in the absence of liver metastases or up to 5 X ULN in case of liver metastases. Total bilirubin ≤ 1.5ULN.
Bone marrow function: Granulocyte count ≥ 1,500/mm3 and platelet count ≥100,000/mm3 and hemoglobin ≥90g/dl.
Renal function: serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 ml/min. (based on modified Cockcroft-Gault formula).
- For all females of childbearing potential a negative serum/urine pregnancy test must be obtained within 48 hours before enrollment. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential.
Exclusion Criteria:Patients with prior chemotherapy or systemic anti-cancer therapy including target therapy targeting HER family members (such as erlotinib, gefitinib, cetuximab, trastuzumab, etc). Previous adjuvant or neo-adjuvant treatment for non-metastatic disease is permitted if completed ≥ 6 months before the enrollments.
- Patients with history of any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
- Patients who have brain metastasis or spinal cord compression. It is permitted if the patient has been treated with surgery and/or radiation with evidence of stable disease for at least 4 weeks.
- Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids.
- Nursing or lactating women.
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
- Unwilling to write informed consent to participate in the study.
- Patients who is unwilling to accept the follow-up.
Sites / Locations
- Guangdong General Hospital & Guangdong Academy of Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
chemotherapy and erlotinib
Arm Description
Intercalated combination of chemotherapy and erlotinib in 1st line setting for patients with advanced stage non-small-cell lung cancer with low abundant activating EGFR mutation
Outcomes
Primary Outcome Measures
Progression free survival defined by imagery methods
From start of anti-cancer therapy untill progression or death
Secondary Outcome Measures
Toxicities related to anti-cancer therapy
From start of anti-cancer therapy till progression of death
Full Information
NCT ID
NCT02095782
First Posted
March 19, 2014
Last Updated
March 2, 2017
Sponsor
Guangdong Association of Clinical Trials
1. Study Identification
Unique Protocol Identification Number
NCT02095782
Brief Title
Chemotherapy and Erlotinib for Lung Cancer With Low Abundance Epidermal Growth Factor Receptor Mutation
Acronym
INNOVATE
Official Title
Intercalated Combination of Chemotherapy and Erlotinib in 1st Line Setting for Patients Advanced Stage Non-small-cell Lung Cancer With Low Abundant Activating EGFR Mutation(INNOVATE)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Because of the very slow enrollment, this study was stopped.
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 20, 2017 (Actual)
Study Completion Date
January 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Association of Clinical Trials
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a single arm phase II clinical trial, which aims to evaluate the effectiveness of intercalated combination of doublet chemotherapy of paclitaxel plus carboplatin and erlotinib on patients with advanced stage non-small-cell lung cancer with low abundant activating EGFR mutation.
Detailed Description
Primary therapy stage:
Paclitaxel Patients receive six cycles of Paclitaxel (175 mg/m² on days 1 of a 4 week cycle, intravenously) plus carboplatin (AUC=5, intravenously on day 1 of a 4 week cycle, intravenously) with sequential erlotinib (150 mg/day) on days 8-21 of each cycle.
Maintenance therapy stage:
Patients, who complete 6 cycles of therapy without progression or intolerable toxicity, receive erlotinib (150 mg/day) as maintenance therapy until progression, intolerable toxicity or death.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small-cell Lung Cancer
Keywords
non-small cell lung cancer, erlotinib, chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
chemotherapy and erlotinib
Arm Type
Experimental
Arm Description
Intercalated combination of chemotherapy and erlotinib in 1st line setting for patients with advanced stage non-small-cell lung cancer with low abundant activating EGFR mutation
Intervention Type
Drug
Intervention Name(s)
Intercalated combination of chemotherapy and erlotinib
Other Intervention Name(s)
paclitaxel plus carboplatin and targeted therapy erlotinib
Intervention Description
Primary therapy stage:
Paclitaxel Patients receive six cycles of Paclitaxel (175 mg/m² on days 1 of a 4 week cycle, intravenously) plus carboplatin (AUC=5, intravenously on day 1 of a 4 week cycle, intravenously) with sequential erlotinib (150 mg/day) on days 8-21 of each cycle.
Maintenance therapy stage:
Patients, who complete 6 cycles of therapy without progression or intolerable toxicity, receive erlotinib (150 mg/day) as maintenance therapy until progression, intolerable toxicity or death.
Primary Outcome Measure Information:
Title
Progression free survival defined by imagery methods
Description
From start of anti-cancer therapy untill progression or death
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Toxicities related to anti-cancer therapy
Description
From start of anti-cancer therapy till progression of death
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Patients with histologically documented, locally advanced or recurrent (stage IIIb and not amenable to combined modality treatment) or metastatic (stage IV) non-small cell lung cancer.
Low abundant activating EGFR mutation: EGFR exon 19 deletion or exon 21 L858R, which are positive by real-time PCR methods and negative by standard sequencing methods.
Uncommon EGFR mutations are included excluding exon 20 mutations. ECOG performance status of ≤ 2. Patients can administer first line setting of platinum based chemotherapy. Patients must have measurable disease according to the RECIST (version 1.1) criteria.
Life expectancy of at least 12 weeks.
Age ≥ 18 years.
Written (signed) informed Consent to participate in the study.
Adequate organ function as defined by the following criteria:
Liver function: SGOT (AST) and SGPT (ALT) ≤ 2.5 X ULN in the absence of liver metastases or up to 5 X ULN in case of liver metastases. Total bilirubin ≤ 1.5ULN.
Bone marrow function: Granulocyte count ≥ 1,500/mm3 and platelet count ≥100,000/mm3 and hemoglobin ≥90g/dl.
Renal function: serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 ml/min. (based on modified Cockcroft-Gault formula).
For all females of childbearing potential a negative serum/urine pregnancy test must be obtained within 48 hours before enrollment. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential.
Exclusion Criteria:Patients with prior chemotherapy or systemic anti-cancer therapy including target therapy targeting HER family members (such as erlotinib, gefitinib, cetuximab, trastuzumab, etc). Previous adjuvant or neo-adjuvant treatment for non-metastatic disease is permitted if completed ≥ 6 months before the enrollments.
Patients with history of any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
Patients who have brain metastasis or spinal cord compression. It is permitted if the patient has been treated with surgery and/or radiation with evidence of stable disease for at least 4 weeks.
Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids.
Nursing or lactating women.
Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
Unwilling to write informed consent to participate in the study.
Patients who is unwilling to accept the follow-up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Long Wu
Organizational Affiliation
Guangdong General Hospital (GGH)& Guangdong Academy of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zhen Wang, PhD
Organizational Affiliation
Guangdong General Hospital & Guangdong Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong General Hospital & Guangdong Academy of Medical Sciences
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
Learn more about this trial
Chemotherapy and Erlotinib for Lung Cancer With Low Abundance Epidermal Growth Factor Receptor Mutation
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