Pharmacogenomic Study for Providing Personalized Strategy to the Treatment of Non-small Cell Lung Cancer (NSCLC) IIIB/IV
Randomized phase2 Study of IP vs. GP as the First-line Therapy Followed by Two Different Sequences as the 2nd or 3rd-line Therapy for Patients With Advanced NSCLC;
1 other identifier
interventional
289
1 country
1
Brief Summary
The primary objective of this randomized phase II study is to compare the Response Rate of each sequence of treatment approach in patients with advanced NSCLC. Additionally, development of gene expression profiles and genotypes that can predict response to commonly used chemotherapy may provide a unique opportunity to better utilize drugs shown to be effective in first- or second-line therapy. Here, the investigators will conduct a pharmacogenomic study to provide rational approach to the treatment of NSCLC by developing predictors of cisplatin (first-line agent) and pemetrexed or docetaxel (second-line agents) sensitivity and demonstrating the clinical value of identifying the most appropriate drug on the basis of sensitivity profile for the treatment regimen of each individual patient. Such an approach is likely to maximize response to chemotherapy and may change the current empirical paradigm of NSCLC therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 28, 2009
CompletedFirst Posted
Study publicly available on registry
October 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedApril 12, 2022
April 1, 2022
6.3 years
October 28, 2009
April 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response Rate
every 6 weeks
Secondary Outcomes (4)
Overall survival (OS)
every 8 weeks
Progression-free survival (PFS)
every 6 weeeks
adverse event
every 3 weeks
Pharmacogenomic study using tumor tissue and blood for providing rational strategy to the treatment of advanced NSCLC
2 times
Study Arms (2)
GP group
EXPERIMENTALGemcitabine (1250 mg/m2) IV on D 1, 8. Cisplatin (75 mg/m2) IV on D1 every 3 weeks.
IP group
EXPERIMENTALIrinotecan (65 mg/m2) IV on day1 , 8 Cisplatin (30 mg/m2) IV on day 1 , 8 every 3 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Histologic diagnosis of NSCLC, Stage IV or selected stage IIIB (malignant pleural or pericardial effusion or supraclavicular adenopathy) according to the American Joint Committee on Cancer (AJCC).
- Adequate tumor tissues for ERCC1 analysis.
- No prior chemotherapy.
- Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
- No other forms of cancer therapy, such as radiation, immunotherapy and major surgery for at least 3 weeks before the enrollment in study.
- Performance status of 0, 1, or 2 on the ECOG criteria.
- Measurable disease, according to the Response Evaluation Criteria in Solid Tumors(RECIST), the presence of at least one unidimensionally measurable lesion with longest diameter 10mm by spiral CT scan.
- Estimated life expectancy of at least 12 weeks.
- Patient compliance that allow adequate follow-up.
- Adequate hematologic and renal function.
- Informed consent from patient or patient's relative.
- Males or females at least 18 years of age.
- No pregnancy or breast feeding.
- Patients with brain metastasis are allowed unless there were clinically significant neurological symptoms or signs
You may not qualify if:
- MI within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia.
- Serious concomitant infection.
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, South Korea
Related Publications (1)
Han JY, Choi JJ, Kim JY, Han YL, Lee GK. PNA clamping-assisted fluorescence melting curve analysis for detecting EGFR and KRAS mutations in the circulating tumor DNA of patients with advanced non-small cell lung cancer. BMC Cancer. 2016 Aug 12;16:627. doi: 10.1186/s12885-016-2678-2.
PMID: 27519791DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
JI-YOUN HAN, M.D.
National Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head, Center for Lung Cancer
Study Record Dates
First Submitted
October 28, 2009
First Posted
October 29, 2009
Study Start
February 1, 2009
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
April 12, 2022
Record last verified: 2022-04