癌研連線CancerLink
招募中 NCT07489066

Symbiotic-Lung-10 ：在早期或局部晚期NSCLC中单独或联合使用PF-08634404的研究

非小细胞肺癌食管癌Phase III 期II 期III 期IV 期EGFRALKPD-L1

进行这项研究是为了更多地了解一种名为PF-08634404的新药。 研究团队希望了解单独给予或与化疗一起给予时，其效果如何。 本研究适用于患有早期或局部晚期非小细胞肺癌（ NSCLC ）的成年人，这些癌症可能可通过手术切除，也可能不可通过手术切除。 本研究正在寻找符合以下条件的参与者： *年满18岁 *具备以下任一条件： *早期或局部晚期（ II期或IIIA/B期） NS

适应症：Carcinoma、Non-Small-Cell Lung、Lung Cancer (NSCLC)、Lung Neoplasms、Carcinoma, Non-Small-Cell Lung (NSCLC)、Lung Disease、Non-Small Cell Lung Cancer、Non-small Cell Lung Cancer, Non-squamous、Non-small Cell Lung Cancer, Squamous

入组条件

纳入标准

  • 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.

排除标准

  • 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.

入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。