計劃書編號A8501002
試驗已結束
2005-12-01 - 2008-06-01
Phase III
終止收納5
ICD-10C34.90
未明示側性支氣管或肺惡性腫瘤
ICD-10C34.91
右側支氣管或肺惡性腫瘤
ICD-10C34.92
左側支氣管或肺惡性腫瘤
ICD-10C7A.090
支氣管及肺惡性類癌
ICD-10Z51.12
來院接受抗腫瘤免疫療法
ICD-9162.9
支氣管及肺惡性腫瘤
多國多中心、隨機、開放性第三期臨床試驗：gemcitabine/cisplatin合併PF-3512676與單獨使用gemcitabine/cisplatin作為晚期非小細胞肺癌患者一線治療的療效比較
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試驗委託 / 贊助單位名稱
輝瑞大藥廠股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 終止收納
實際收案人數
0 終止收納
實際收案人數
0 終止收納
適應症
非小細胞肺癌(NSCLC)
試驗目的
此為一多國、隨機、開放標籤、第3階段臨床試驗:用於評估PF-3512676合併Gemcitabine/Cisplatin相較於單獨使用Gemcitabine/ Cisplatin化療，用於第一線治療晚期非小細胞肺癌病患的療效和安全性。
藥品名稱
注射劑
主成份
PF-3512676
劑型
270
劑量
15 mg/mL
評估指標
- Overall survival defined as the time from randomization to the date of death due to any cause.
主要納入條件
1. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
Cytologic specimens for diagnosis or for cell type classification must have been obtained from bronchial brushings or washings or from needle aspiration of a defined lesion. Sputum cytology alone will not be acceptable for diagnosis or for cell type classification.
2. Advanced NSCLC with documented AJCC Stage IIIB (with pleural effusion) or Stage IV disease.
3. Measurable disease defined by at least one lesion that can be accurately measured in at least one dimension as >=20 mm with conventional techniques or >=10 mm with spiral CT scan within 28 days prior to the planned start of study treatment (RECIST criteria). Note: Prior radiation to the only site of measurable disease will deem the patient ineligible unless progression is documented at the site after completion of radiation.
4. No prior systemic treatment for NSCLC with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs.
5. Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to enrollment and all acute toxicities have resolved to baseline or to CTC Grade 1 (NCI CTCAE v3.0)
6. Males or females aged >=18 years
7. ECOG performance status (PS) 0 or 1
8. Adequate organ function as determine by the following criteria:
- Absolute neutrophil count (ANC) >=1.5 x 10 000 000 000/L.
- Platelet count >=100 x 10 000 000 000/L
- Calculated creatinine clearance >= 50 mL/min or measured creatinine clearance >=60 mL/min
- AST (SGOT) and ALT (SGPT) =<3 x ULN (AST and ALT =<5 x ULN is acceptable, in the presence of liver metastatses)
- Total bilirubin =<1.5 x ULN
9. Female patients or their partners must be surgically sterile or be postmenopausal, or must agree to use effective contraception while receiving study treatment and for at least 3 months thereafter. All female patients with reproductive potential must have a negative pregnancy test (serum/urine) within the 72 hours prior to starting treatment. Male patients or their partners must be surgically sterile or must agree to use effective contraception while receiving study treatment and for at least 3 months thereafter. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
10. Written, voluntary informed consent provided
Cytologic specimens for diagnosis or for cell type classification must have been obtained from bronchial brushings or washings or from needle aspiration of a defined lesion. Sputum cytology alone will not be acceptable for diagnosis or for cell type classification.
2. Advanced NSCLC with documented AJCC Stage IIIB (with pleural effusion) or Stage IV disease.
3. Measurable disease defined by at least one lesion that can be accurately measured in at least one dimension as >=20 mm with conventional techniques or >=10 mm with spiral CT scan within 28 days prior to the planned start of study treatment (RECIST criteria). Note: Prior radiation to the only site of measurable disease will deem the patient ineligible unless progression is documented at the site after completion of radiation.
4. No prior systemic treatment for NSCLC with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs.
5. Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to enrollment and all acute toxicities have resolved to baseline or to CTC Grade 1 (NCI CTCAE v3.0)
6. Males or females aged >=18 years
7. ECOG performance status (PS) 0 or 1
8. Adequate organ function as determine by the following criteria:
- Absolute neutrophil count (ANC) >=1.5 x 10 000 000 000/L.
- Platelet count >=100 x 10 000 000 000/L
- Calculated creatinine clearance >= 50 mL/min or measured creatinine clearance >=60 mL/min
- AST (SGOT) and ALT (SGPT) =<3 x ULN (AST and ALT =<5 x ULN is acceptable, in the presence of liver metastatses)
- Total bilirubin =<1.5 x ULN
9. Female patients or their partners must be surgically sterile or be postmenopausal, or must agree to use effective contraception while receiving study treatment and for at least 3 months thereafter. All female patients with reproductive potential must have a negative pregnancy test (serum/urine) within the 72 hours prior to starting treatment. Male patients or their partners must be surgically sterile or must agree to use effective contraception while receiving study treatment and for at least 3 months thereafter. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
10. Written, voluntary informed consent provided
主要排除條件
1. Any histological/cytological evidence of small cell or carcinoid lung cancer.
2. Known central nervous system (CNS) metastasis.
CNS imaging is not required at baseline for patients who have no symptoms suggestive of CNS metastases
3. Any acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with study participation or study drug administration or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study. This includes:
- Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus, erythematosis, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, autoimmune thrombocytopenia, or glomerulonephritis.
- History of allogeneic transplant
- Untreated or uncontrolled superior vena cava syndrome
- Untreated or uncontrolled hypercalcemia
- Requirement for chronic treatment with therapeutic doses of systemic corticosteroids. Use of steroid inhalers, or oral “physiologic replacement” doses of corticosteroids is permitted. Physiological replacement doses will be defined as =<37.5 mg/day of cortisone, =<7.5 mg/day of prednisolone or =<1.0 mg/day of dexamethasone. Patients on other replacement regimens must be discussed with the sponsor.
- Uncontrolled hypertension, unstable angina, myocardial infarction or symptomatic congestive heart failure within the past 12 months or serious uncontrolled cardiac arrhythmia.
- Active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HBC) and human immunodeficiency virus (HIV). Serological testing will not be required at baseline for patients who have no symptoms suggestive of infection.
- Pre-existing peripheral neuropathy >= CTC Grade 2.
- Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent or compliance with the requirements of the protocol.
4. History of any active malignancy (other than NSCLC) during the last 3 years except non melanoma skin cancer, in situ cervical cancer, or cured, early prostate cancer in a patient with PSA level < ULN.
5. Known or suspected hypersensitivity to any of the study drugs (gemcitabin, cisplatin or PF-3512676), study drug classes (pyrimidine analogs, platinum, oligodeoxynucleotide ODN) or excipients in the formulation of study drugs.
6. Female patients who are pregnant or nursing.
7. Inability or lack of willingness to comply with scheduled visits, therapy plans or laboratory tests.
8. Current enrollment in another therapeutic clinical trial.
9. Use of any investigational agent in the past 4 weeks.
2. Known central nervous system (CNS) metastasis.
CNS imaging is not required at baseline for patients who have no symptoms suggestive of CNS metastases
3. Any acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with study participation or study drug administration or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study. This includes:
- Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus, erythematosis, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, autoimmune thrombocytopenia, or glomerulonephritis.
- History of allogeneic transplant
- Untreated or uncontrolled superior vena cava syndrome
- Untreated or uncontrolled hypercalcemia
- Requirement for chronic treatment with therapeutic doses of systemic corticosteroids. Use of steroid inhalers, or oral “physiologic replacement” doses of corticosteroids is permitted. Physiological replacement doses will be defined as =<37.5 mg/day of cortisone, =<7.5 mg/day of prednisolone or =<1.0 mg/day of dexamethasone. Patients on other replacement regimens must be discussed with the sponsor.
- Uncontrolled hypertension, unstable angina, myocardial infarction or symptomatic congestive heart failure within the past 12 months or serious uncontrolled cardiac arrhythmia.
- Active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HBC) and human immunodeficiency virus (HIV). Serological testing will not be required at baseline for patients who have no symptoms suggestive of infection.
- Pre-existing peripheral neuropathy >= CTC Grade 2.
- Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent or compliance with the requirements of the protocol.
4. History of any active malignancy (other than NSCLC) during the last 3 years except non melanoma skin cancer, in situ cervical cancer, or cured, early prostate cancer in a patient with PSA level < ULN.
5. Known or suspected hypersensitivity to any of the study drugs (gemcitabin, cisplatin or PF-3512676), study drug classes (pyrimidine analogs, platinum, oligodeoxynucleotide ODN) or excipients in the formulation of study drugs.
6. Female patients who are pregnant or nursing.
7. Inability or lack of willingness to comply with scheduled visits, therapy plans or laboratory tests.
8. Current enrollment in another therapeutic clinical trial.
9. Use of any investigational agent in the past 4 weeks.
試驗計畫預計收納受試者人數
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台灣人數
40 人
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全球人數
800 人
