Pharmacogenomic Study for Providing Personalized Strategy to the Treatment of Non-small Cell Lung Cancer (NSCLC) IIIB/IV
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ClinicalTrials.gov Identifier: NCT01003964 |
Recruitment Status :
Completed
First Posted : October 29, 2009
Last Update Posted : April 12, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Small Cell Lung Cancer | Drug: IP Drug: GP | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 289 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | February 2009 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | June 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: GP group
Gemcitabine (1250 mg/m2) IV on D 1, 8. Cisplatin (75 mg/m2) IV on D1 every 3 weeks.
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Drug: GP
Gemcitabine (1250 mg/m2) IV on D 1, 8. Cisplatin (75 mg/m2) IV on D1 every 3 weeks.
Other Name: Gemcitabine, Cisplatin |
Experimental: IP group
Irinotecan (65 mg/m2) IV on day1 , 8 Cisplatin (30 mg/m2) IV on day 1 , 8 every 3 weeks
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Drug: IP
Irinotecan (65 mg/m2) IV on day1 , 8 Cisplatin (30 mg/m2) IV on day 1 , 8 every 3 weeks
Other Name: Irrinotecan, Cisplatin |
- Response Rate [ Time Frame: every 6 weeks ]
- Overall survival (OS) [ Time Frame: every 8 weeks ]from the first day of treatment to death
- Progression-free survival (PFS) [ Time Frame: every 6 weeeks ]as the period between the day of the treatment and the date of progression or death
- adverse event [ Time Frame: every 3 weeks ]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 [ Time Frame: 2 times ]at baseline and time to disease progression

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003964
Korea, Republic of | |
National Cancer Center, Korea | |
Goyang-si, Gyeonggi-do, Korea, Republic of |
Principal Investigator: | JI-YOUN HAN, M.D. | National Cancer Center |
Responsible Party: | Ji-youn Han, Head, Center for Lung Cancer, National Cancer Center, Korea |
ClinicalTrials.gov Identifier: | NCT01003964 |
Other Study ID Numbers: |
NCCCTS-08-371 |
First Posted: | October 29, 2009 Key Record Dates |
Last Update Posted: | April 12, 2022 |
Last Verified: | April 2022 |
NON-SMALL CELL LUNG CANCER excision repair cross-complementing 1 Gemcitabine and cisplatin Irinotecan and cisplatin advanced NSCLC |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Gemcitabine |
Cisplatin Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |