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Pharmacogenomic Study for Providing Personalized Strategy to the Treatment of Non-small Cell Lung Cancer (NSCLC) IIIB/IV

Primary Purpose

Non Small Cell Lung Cancer

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring NON-SMALL CELL LUNG CANCER, excision repair cross-complementing 1, Gemcitabine and cisplatin, Irinotecan and cisplatin, advanced NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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).

Sites / Locations

National Cancer Center, Korea

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

GP group

IP group

Arm Description

Gemcitabine (1250 mg/m2) IV on D 1, 8. Cisplatin (75 mg/m2) IV on D1 every 3 weeks.

Irinotecan (65 mg/m2) IV on day1 , 8 Cisplatin (30 mg/m2) IV on day 1 , 8 every 3 weeks

Outcomes

Primary Outcome Measures

Response Rate

Secondary Outcome Measures

Overall survival (OS)

from the first day of treatment to death

Progression-free survival (PFS)

as the period between the day of the treatment and the date of progression or death

adverse event

from C1D1 to 30 days after the last dose administration

Pharmacogenomic study using tumor tissue and blood for providing rational strategy to the treatment of advanced NSCLC

at baseline and time to disease progression

Full Information

NCT ID

NCT01003964

First Posted

October 28, 2009

Last Updated

April 4, 2022

Sponsor

National Cancer Center, Korea

1. Study Identification

Unique Protocol Identification Number

NCT01003964

Brief Title

Pharmacogenomic Study for Providing Personalized Strategy to the Treatment of Non-small Cell Lung Cancer (NSCLC) IIIB/IV

Official Title

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;

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Cancer Center, Korea

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Cisplatin-based chemotherapy is currently considered to be the standard treatment in advanced non-small cell lung cancer (NSCLC). However, overall response is only 30-40%, suggesting that a majority of the patients do not respond to platinum. Subsequently, those patients who experience treatment failure with platinum-based therapy typically received pemetrexed or docetaxel as second-line treatment, with response rate of approximately 7% to 10%. 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, we 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.

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, excision repair cross-complementing 1, Gemcitabine and cisplatin, Irinotecan and cisplatin, advanced NSCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

289 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GP group

Arm Type

Experimental

Arm Description

Gemcitabine (1250 mg/m2) IV on D 1, 8. Cisplatin (75 mg/m2) IV on D1 every 3 weeks.

Arm Title

IP group

Arm Type

Experimental

Arm Description

Irinotecan (65 mg/m2) IV on day1 , 8 Cisplatin (30 mg/m2) IV on day 1 , 8 every 3 weeks

Intervention Type

Drug

Intervention Name(s)

Other Intervention Name(s)

Irrinotecan, Cisplatin

Intervention Description

Irinotecan (65 mg/m2) IV on day1 , 8 Cisplatin (30 mg/m2) IV on day 1 , 8 every 3 weeks

Intervention Type

Drug

Intervention Name(s)

Other Intervention Name(s)

Gemcitabine, Cisplatin

Intervention Description

Gemcitabine (1250 mg/m2) IV on D 1, 8. Cisplatin (75 mg/m2) IV on D1 every 3 weeks.

Primary Outcome Measure Information:

Title

Response Rate

Time Frame

every 6 weeks

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

from the first day of treatment to death

Time Frame

every 8 weeks

Title

Progression-free survival (PFS)

Description

as the period between the day of the treatment and the date of progression or death

Time Frame

every 6 weeeks

Title

adverse event

Description

from C1D1 to 30 days after the last dose administration

Time Frame

every 3 weeks

Title

Pharmacogenomic study using tumor tissue and blood for providing rational strategy to the treatment of advanced NSCLC

Description

at baseline and time to disease progression

Time Frame

2 times

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JI-YOUN HAN, M.D.

Organizational Affiliation

National Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Center, Korea

City

Goyang-si

State/Province

Gyeonggi-do

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

27519791

Citation

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. Erratum In: BMC Cancer. 2016 Oct 17;16(1):803.

Results Reference

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Pharmacogenomic Study for Providing Personalized Strategy to the Treatment of Non-small Cell Lung Cancer (NSCLC) IIIB/IV

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