Clinical Trials List
Protocol NumberC6461014
NCT Number(ClinicalTrials.gov Identfier)NCT07476287
Not yet recruiting
2026-03-16 - 2031-11-30
Phase II
Recruiting4
A PHASE 2 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY UNTREATED TRANSFORMED SMALL CELL LUNG CANCER
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/09/10
Investigators and Locations
Co-Principal Investigator
- CHAO-CHI HO CHAO-CHI HO 無
- 廖斌志 無
- James Chih-Hsin Yang 無
- 廖唯昱 無
- 錢穎群 無
- 蔡子修 無
- 徐偉勛 無
- Jih-Hsiang Lee 無
- 許嘉林 無
- 陳冠宇 無
- 于鎧綸 無
- 楊景堯 無
- 黃俊凱 無
- 黃信端 無
- YEN-TING LIN 無
- Chia-Chi Lin 無
- 黃得瑞 無
- Chong-Jen Yu 無
- 吳尚俊 無
- 張立群 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- James Chih-Hsin Yang 無
- JIN-YUAN SHIH 無
- 吳尚俊 無
- 黃得瑞 無
- YEN-TING LIN 無
- 廖斌志 無
- Chia-Chi Lin 無
- 林宗哲 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chia-I Shen 無
- Hsu-ching Huang 無
- 廖映庭 無
- 趙恒勝 無
- 蕭慈慧 無
- Yung-Hung Luo 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chien-Chung Lin
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Small Cell Lung Cancer
Objectives
本試驗旨在針對第一線情境的 T-SCLC 參與者，評估 PF-08634404 併用 carboplatin 和 etoposide 4 個週期，然後進行 PF-08634404 單一療法的安全性、耐受性、藥物動力學 (PK) 和抗腫瘤活性。
Test Drug
注射劑
注射劑
注射劑
注射劑
注射劑
Active Ingredient
PF-08634404
CARBOPLATIN
ETOPOSIDE
CARBOPLATIN
ETOPOSIDE
Dosage Form
270
270
270
270
270
Dosage
200mg/10mL
450mg/45mL
100mg/5mL
450mg/45mL
100mg/5mL
Endpoints
•試驗主持人根據 RECIST v1.1 評估確認的 ORR
•AE 依類型、頻率、嚴重程度 (依 NCI CTCAE 第 5.0 版分級)、時間點、嚴重性和試驗介入治療的關係描述特性。
•AE 依類型、頻率、嚴重程度 (依 NCI CTCAE 第 5.0 版分級)、時間點、嚴重性和試驗介入治療的關係描述特性。
Inclution Criteria
Inclusion Criteria:
Male or female participants aged ≥18 years at the time of informed consent.
Histologically or cytologically confirmed T-SCLC. Participant must have had a prior diagnosis of NSCLC with EGFR mutation which transformed to SCLC following the treatment with TKI(s).
Participants have not received systemic therapy for T-SCLC.
Have at least one measurable lesion as the target lesion based on RECIST v1.1.
Have sufficient tumor tissue from the diagnosis of transformed SCLC available.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Have a minimum life expectancy of >12 weeks.
Clinical laboratory values at screening within acceptable limits, as defined in the protocol, including: 1) Hematology, 2) Liver function and 3) Renal function.
Male or female participants aged ≥18 years at the time of informed consent.
Histologically or cytologically confirmed T-SCLC. Participant must have had a prior diagnosis of NSCLC with EGFR mutation which transformed to SCLC following the treatment with TKI(s).
Participants have not received systemic therapy for T-SCLC.
Have at least one measurable lesion as the target lesion based on RECIST v1.1.
Have sufficient tumor tissue from the diagnosis of transformed SCLC available.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Have a minimum life expectancy of >12 weeks.
Clinical laboratory values at screening within acceptable limits, as defined in the protocol, including: 1) Hematology, 2) Liver function and 3) Renal function.
Exclusion Criteria
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Active or untreated CNS disease, including brain, brainstem, spinal cord, or meningeal metastases. Participants with definitively treated, clinically stable brain metastases may be eligible per protocol criteria. Participants with untreated asymptomatic brain metastases of longest diameter <1 cm are permitted if all of the following criteria are met: absence of neurological symptoms, no need for corticosteroids, and brain metastasis has no evidence of edema or hemorrhagic features.
Leptomeningeal disease
Clinically significant risk of hemorrhage or fistula, including tumor necrosis/cavitation, invasion or compression of major blood vessels, airways, or critical organs, or risk of tracheoesophageal or pleuroesophageal fistula
History of another malignancy (other than NSCLC) within 3 years prior to first dose, except for malignancies with negligible risk of metastasis or death (eg, adequately treated carcinoma in situ, nonmelanoma skin cancer)
Unresolved toxicity from prior anti-tumor therapy that has not recovered to Grade ≤1 per NCI CTCAE v5.0 (except alopecia or irreversible toxicities deemed stable)
History of allogeneic organ or hematopoietic stem cell transplantation
Active autoimmune disease requiring systemic treatment within the past 2 years (Stable replacement therapy and selected low-risk autoimmune conditions are permitted per protocol)
Interstitial lung disease (ILD), pneumonitis, or significant pulmonary disease, including:
Prior or current non-infectious pneumonitis requiring systemic therapy
DLCO <50% predicted
Severe asthma, COPD, pulmonary embolism, or autoimmune lung involvement
Uncontrolled or clinically significant cardiovascular, cerebrovascular, metabolic, hepatic, or renal disease within 6 months prior to first dose
Baseline QTcF >480 msec
Major surgery or severe trauma within 4 weeks prior to first dose, or planned major surgery during the study
Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage
History of significant bleeding disorders or recent major bleeding events
Clinically significant gastrointestinal conditions, including recent perforation, fistula, obstruction, or active bleeding
Active, uncontrolled, or symptomatic infection, including:
Active TB
Active hepatitis B or C
Uncontrolled HIV infection
History of immunodeficiency
Severe hypersensitivity or allergic reactions to study intervention components or monoclonal antibodies
Psychiatric illness or medical condition, including recent suicidal ideation or behavior, that may increase risk or interfere with study participation
Prior anti-angiogenic therapy or other prohibited anti-tumor or immunomodulatory therapies per protocol-specified washout periods
Use of prohibited concomitant medications, including high-dose systemic corticosteroids, certain anticoagulants, or live vaccines within protocol-specified timeframes
Recent participation in another investigational study (within 30 days or 5 half-lives, whichever is longer)
Pregnant or breastfeeding participants, or unwillingness to comply with contraception requirements
Participants are excluded from the study if any of the following criteria apply:
Active or untreated CNS disease, including brain, brainstem, spinal cord, or meningeal metastases. Participants with definitively treated, clinically stable brain metastases may be eligible per protocol criteria. Participants with untreated asymptomatic brain metastases of longest diameter <1 cm are permitted if all of the following criteria are met: absence of neurological symptoms, no need for corticosteroids, and brain metastasis has no evidence of edema or hemorrhagic features.
Leptomeningeal disease
Clinically significant risk of hemorrhage or fistula, including tumor necrosis/cavitation, invasion or compression of major blood vessels, airways, or critical organs, or risk of tracheoesophageal or pleuroesophageal fistula
History of another malignancy (other than NSCLC) within 3 years prior to first dose, except for malignancies with negligible risk of metastasis or death (eg, adequately treated carcinoma in situ, nonmelanoma skin cancer)
Unresolved toxicity from prior anti-tumor therapy that has not recovered to Grade ≤1 per NCI CTCAE v5.0 (except alopecia or irreversible toxicities deemed stable)
History of allogeneic organ or hematopoietic stem cell transplantation
Active autoimmune disease requiring systemic treatment within the past 2 years (Stable replacement therapy and selected low-risk autoimmune conditions are permitted per protocol)
Interstitial lung disease (ILD), pneumonitis, or significant pulmonary disease, including:
Prior or current non-infectious pneumonitis requiring systemic therapy
DLCO <50% predicted
Severe asthma, COPD, pulmonary embolism, or autoimmune lung involvement
Uncontrolled or clinically significant cardiovascular, cerebrovascular, metabolic, hepatic, or renal disease within 6 months prior to first dose
Baseline QTcF >480 msec
Major surgery or severe trauma within 4 weeks prior to first dose, or planned major surgery during the study
Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage
History of significant bleeding disorders or recent major bleeding events
Clinically significant gastrointestinal conditions, including recent perforation, fistula, obstruction, or active bleeding
Active, uncontrolled, or symptomatic infection, including:
Active TB
Active hepatitis B or C
Uncontrolled HIV infection
History of immunodeficiency
Severe hypersensitivity or allergic reactions to study intervention components or monoclonal antibodies
Psychiatric illness or medical condition, including recent suicidal ideation or behavior, that may increase risk or interfere with study participation
Prior anti-angiogenic therapy or other prohibited anti-tumor or immunomodulatory therapies per protocol-specified washout periods
Use of prohibited concomitant medications, including high-dose systemic corticosteroids, certain anticoagulants, or live vaccines within protocol-specified timeframes
Recent participation in another investigational study (within 30 days or 5 half-lives, whichever is longer)
Pregnant or breastfeeding participants, or unwillingness to comply with contraception requirements
The Estimated Number of Participants
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Taiwan
12 participants
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Global
40 participants
