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Clinical Trials List

Protocol NumberC6461004

NCT Number(ClinicalTrials.gov Identfier)NCT07226999

Active

2026-03-30 - 2032-08-31

Phase II

Not yet recruiting3

Recruiting2

A GLOBAL PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER

Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/09/10

Investigators and Locations

Principal Investigator JIN-YUAN SHIH Division of Hematology & Oncology

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chao-Hua Chiu Division of Thoracic Medicine

Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Gee-chen Chang Division of Thoracic Medicine

Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yung-Hung Luo Division of Thoracic Medicine

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Small Cell Lung Cancer (SCLC)

Objectives

本試驗的第 2 期部分旨在評估 PF-08634404 加上化療的安全性、耐受性和初步療效，接著第 3 期部分將評估 PF-08634404 加上化療相較於 atezolizumab 加上化療用於 ES-SCLC 參與者在第一線情境下的療效。

Test Drug

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Active Ingredient

PF-08634404
CARBOPLATIN
ETOPOSIDE

Dosage Form

27C
27C
27C

Dosage

200mg/10mL/vial
450mg/45mL/Vial
100mg/5mL/Vial

Endpoints

Phase 2
• 試驗主持人根據 RECIST v1.1 評估確認的 ORR
• AE 按類型、頻率、嚴重程度 (按 NCI CTCAE 第 5.0 版分級)、時間點、嚴重性、與試驗介入治療的關係分類。
Phase 3
• OS

Inclution Criteria

Inclusion Criteria:

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 V1.1.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Adequate organ function

Exclusion Criteria

Exclusion Criteria:

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

The Estimated Number of Participants

Taiwan

36 participants
Global

540 participants