A GLOBAL PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 550
- 试验地点
- 83
- 主要终点
- Phase 2: Confirmed Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] based on the investigator's assessment
研究概览
简要总结
This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to adults with extensive-stage small cell lung cancer (ES-SCLC), a fast-growing type of lung cancer that has spread widely in the body.
To join the study, participants must meet the following conditions:
- Be 18 years or older.
- Have extensive-stage small cell lung cancer confirmed by lab tests.
- Have not received chemotherapy or radiation for this type of lung cancer.
- Be in good physical condition and have healthy organs based on medical tests.
The study has two parts:
- In the first part, researchers will check how safe the study medicine is and how well people tolerate it when given with chemotherapy.
- In the second part, they will compare study medicine plus chemotherapy to another approved treatment (atezolizumab plus chemotherapy) to see which works better.
Participants will receive the treatment through IV infusions (medicine given directly into a vein). The treatment will be given in repeated time periods called cycles. Some participants will continue receiving the study medicine alone after the initial treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Phase 2 is open-label, whereas Phase 3 is double-blind, randomized design.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
- •Participants have not received systemic therapy (chemotherapy, radiotherapy, chemoradiation) for ES-SCLC.
- •Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
- •Have at least one measurable lesion as the targeted lesion based on RECIST V1.
- •Eastern Cooperative Oncology Group performance status of 0 or
- •Adequate organ function
排除标准
- •known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression
- •Leptomeningeal disease
- •Clinically significant risk of hemorrhage or fistula
- •history of another malignancy within 3 years
- •active autoimmune diseases requiring systemic treatment within the past 2 years
研究组 & 干预措施
Phase 2 Single arm
Participants will receive PF-08634404 in combination with chemotherapy
干预措施: PF-08634404 (Drug)
Phase 2 Single arm
Participants will receive PF-08634404 in combination with chemotherapy
干预措施: Chemotherapy (Drug)
Phase 3 Experimental Arm
Participants will receive PF-08634404 in combination with chemotherapy
干预措施: PF-08634404 (Drug)
Phase 3 Experimental Arm
Participants will receive PF-08634404 in combination with chemotherapy
干预措施: Chemotherapy (Drug)
Phase3 Control Arm
Participants will receive atezolizumab in combination with chemotherapy
干预措施: Chemotherapy (Drug)
Phase3 Control Arm
Participants will receive atezolizumab in combination with chemotherapy
干预措施: Atezolizumab (Biological)
结局指标
主要结局
Phase 2: Confirmed Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] based on the investigator's assessment
时间窗: Up to approximately 2 years after completion of study treatment of last study participant
Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) is observed as best overall response. ORR using RECIST v1.1 as assessed by investigator.
Phase 2: Number of participants with treatment-emergent adverse events
时间窗: Up to 90 days after the last dose of treatment
Adverse Events (AEs) as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Phase 3: Overall Survival (OS)
时间窗: Up to approximately 2 years after completion of study treatment of last study participant
OS is defined as the time from the date of randomization to the date of death due to any cause. OS is secondary outcome measure in Phase 2 portion of the study.
次要结局
- Duration of Response (DOR) as assessed by Investigator based on RECIST v1.1(Up to approximately 2 years after completion of study treatment of last study participant)
- Phase 3: PFS using RECIST v1.1 as assessed by blinded independent central review (BICR)(Up to approximately 2 years after completion of study treatment of last study participant)
- Progression Free Survival (PFS) as assessed by investigator based on RECIST v1.1(Up to approximately 2 years after completion of study treatment of last study participant)
- Number of participants with Laboratory abnormalities(Up to 90 days after the last dose of treatment)
- Phase 2: Number of Participants who Experience a Dose-Limiting Toxicity (DLT)(Up to 90 days after the last dose of treatment)
- Pharmacokinetics: Serum concentrations of PF-08634404(Up to 37 days after the last dose of treatment)
- Incidence of antidrug antibody against PF-08634404(Up to 37 days after the last dose of treatment)
- Phase 2: Overall Survival(Up to approximately 2 years after completion of study treatment of last study participant)
- Phase 3: Confirmed ORR using RECIST v1.1 as assessed by BICR(Up to approximately 2 years after completion of study treatment of last study participant)
- Phase 3: DOR using RECIST v1.1 as assessed by BICR(Up to approximately 2 years after completion of study treatment of last study participant)
- Phase 3: Mean scores and Change from baseline in the global health status/quality of life (QoL), function, and symptom scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)(Up to approximately 2 years after completion of study treatment of last study participant)
- Phase 3: Mean scores and Change from Baseline on the EORTC Quality of Life Cancer Questionnaire - Lung Cancer 13 (EORTC QLQ-LC13)(Up to approximately 2 years after completion of study treatment of last study participant)
- Phase 3: Time to definitive deterioration (TTdD) in the global health status/QoL, function, and symptom scores on the EORTC QLQ-C30(Up to approximately 2 years after completion of study treatment of last study participant)
- Phase 3: TTdD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13(Up to approximately 2 years after completion of study treatment of last study participant)