Clinical Trials List
Protocol NumberC6461010
NCT Number(ClinicalTrials.gov Identfier)NCT07489066
Not yet recruiting
2026-06-01 - 2029-12-31
Phase II
Not yet recruiting1
AN INTERVENTIONAL, OPEN-LABEL, PHASE 2 STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY OR IN COMBINATION IN ADULT PARTICIPANTS WITH EARLY-STAGE RESECTABLE OR LOCALLY ADVANCED UNRESECTABLE NON-SMALL CELL LUNG CANCER
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/09/08
Investigators and Locations
Co-Principal Investigator
- Hsao-Hsun Hsu 無
- 陳冠宇 無
- 張立群 無
- 黃信端 無
- 黃得瑞 無
- JIN-SHING CHEN 無
- Mong-Wei Lin 無
- Chong-Jen Yu 無
- 黃俊凱 無
- 廖斌志 無
- 徐偉勛 無
- 錢穎群 無
- SHUENN-WEN KUO 無
- 于鎧綸 無
- Jih-Hsiang Lee 無
- James Chih-Hsin Yang 無
- 許嘉林 無
- YEN-TING LIN 無
- 蔡子修 無
- 楊景堯 無
- 廖唯昱 無
- Chia-Chi Lin 無
- 吳尚俊 無
Principal Investigator
Chao-Hua Chiu
Co-Principal Investigator
- Yu-Chung Wu 無
- Mei-Chuan Chen 無
- 高冠鈞 無
- Kai-Ling Lee 無
Co-Principal Investigator
- 趙恒勝 無
- 廖映庭 無
- Chi-Lu Chiang 無
- Hsu-ching Huang 無
- Chia-I Shen 無
- 蕭慈慧 無
Principal Investigator
Chun-Hui Lee
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Non-Small-Cell Lung
Objectives
本試驗將評估 PF-08634404 合併鉑類化療用於可切除之 NSCLC 的術前輔助 (A 部分)，以及 PF-08634404 作為單一藥物治療作為術後輔助治療 (B 部分) 的安全性和療效。此外，本試驗也將評估 PF-08634404 單一藥物治療作為 LA 不可切除之 NSCLC 化學放射治療後鞏固治療的安全性及療效 (C 部分)。
Test Drug
注射劑
注射劑
注射劑
注射劑
注射劑
注射劑
注射劑
Active Ingredient
PF-08634404
CARBOPLATIN
PACLITAXEL
Pemetrexed
CARBOPLATIN
PACLITAXEL
Pemetrexed
Dosage Form
270
270
270
270
270
270
270
Dosage
200 mg/10 mL
450 mg/45 mL
300 mg/50 mL
500 mg/20 mL
450 mg/45 mL
300 mg/50 mL
500 mg/20 mL
Endpoints
A.
•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。
•接受手術的參與者比例
•術後出現傷口併發症的參與者比例
•pCR 率係根據 IASLC 指南，經中央病理審查評估
B.
•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。
C.
•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。
•接受手術的參與者比例
•術後出現傷口併發症的參與者比例
•pCR 率係根據 IASLC 指南，經中央病理審查評估
B.
•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。
C.
•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:
18 years of age or older at screening.
Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy
PD-L1 status available based on local testing results
Adequate organ function
Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1
Part A only: Participants must have newly diagnosed, previously untreated, pathologically confirmed early-stage or LA (Stage II or IIIA/B), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) with disease that is considered resectable, as assessed by a multidisciplinary evaluation, which must include a thoracic surgeon who performs lung cancer surgery as a prominent part of his/her practice. The participant must be a candidate for neoadjuvant therapy followed by complete surgical resection.
Part B only: Participants must have pathologically confirmed early-stage or LA (Stage II or IIIA/B), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have undergone complete surgical resection. The participant must be considered a candidate for adjuvant therapy and must not have achieved pCR with SOC neoadjuvant chemo-immunotherapy.
Part C only: Participants must have pathologically confirmed LA, unresectable (Stage III) squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have received ≥ 60 Gy of radiation and ≥ 2 cycles of definitive, platinum-based concurrent chemotherapy and achieved SD or better per RECIST 1.1.
18 years of age or older at screening.
Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy
PD-L1 status available based on local testing results
Adequate organ function
Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1
Part A only: Participants must have newly diagnosed, previously untreated, pathologically confirmed early-stage or LA (Stage II or IIIA/B), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) with disease that is considered resectable, as assessed by a multidisciplinary evaluation, which must include a thoracic surgeon who performs lung cancer surgery as a prominent part of his/her practice. The participant must be a candidate for neoadjuvant therapy followed by complete surgical resection.
Part B only: Participants must have pathologically confirmed early-stage or LA (Stage II or IIIA/B), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have undergone complete surgical resection. The participant must be considered a candidate for adjuvant therapy and must not have achieved pCR with SOC neoadjuvant chemo-immunotherapy.
Part C only: Participants must have pathologically confirmed LA, unresectable (Stage III) squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have received ≥ 60 Gy of radiation and ≥ 2 cycles of definitive, platinum-based concurrent chemotherapy and achieved SD or better per RECIST 1.1.
Exclusion Criteria
Exclusion Criteria:
Participants with known EGFR and ALK AGAs; documented negative results for EGFR and ALK AGAs are required for participants with non-squamous histology.
Participants with CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.
Participants with clinically significant risk of hemorrhage or fistula are excluded.
Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.
Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.
History of allogeneic organ / hematopoietic stem cell transplantation.
Participants with any of the following respiratory conditions:
Evidence of noninfectious or drug-induced interstitial lung disease (ILD) or pneumonitis
Grade ≥3 pulmonary disease unrelated to underlying malignancy
History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial/severe venous thromboembolic events.
Major surgery < 4 weeks or minor surgery < 3 days prior to first dose of study intervention.
History of severe bleeding tendency or coagulation dysfunction
History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.
Participants with acute, chronic or symptomatic infections including participants positive for active HIV, hepatitis B virus (HBV), or Hepatitis C virus (HCV).
Participants with history of immunodeficiency
Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.
Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.
Participants with known EGFR and ALK AGAs; documented negative results for EGFR and ALK AGAs are required for participants with non-squamous histology.
Participants with CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.
Participants with clinically significant risk of hemorrhage or fistula are excluded.
Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.
Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.
History of allogeneic organ / hematopoietic stem cell transplantation.
Participants with any of the following respiratory conditions:
Evidence of noninfectious or drug-induced interstitial lung disease (ILD) or pneumonitis
Grade ≥3 pulmonary disease unrelated to underlying malignancy
History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial/severe venous thromboembolic events.
Major surgery < 4 weeks or minor surgery < 3 days prior to first dose of study intervention.
History of severe bleeding tendency or coagulation dysfunction
History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.
Participants with acute, chronic or symptomatic infections including participants positive for active HIV, hepatitis B virus (HBV), or Hepatitis C virus (HCV).
Participants with history of immunodeficiency
Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.
Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.
The Estimated Number of Participants
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Taiwan
25 participants
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Global
120 participants
