2025-523461-17-01招募中3 期
AN INTERVENTIONAL PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer Inc.
- 入组人数
- 387
- 试验地点
- 125
- 主要终点
- Overall survival
研究概览
简要总结
To demonstrate that PF-08634404 + chemotherapy (experimental arm) is superior to pembrolizumab + chemotherapy (control arm) in prolonging OS. To demonstrate that PF-08634404 + chemotherapy (experimental arm) is superior to pembrolizumab + chemotherapy (control arm) in prolonging PFS by BICR.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Have pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV)squamous or non-squamous NSCLC and not be a candidate for complete surgical resection and curative chemoradiation per the AJCC Staging Manual and the UICC Staging System (Eighth edition).
- •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
- •Measurable disease based on RECIST v1.1 per investigator.
- •ECOG PS score of 0 or 1
- •Expected survival ≥12 weeks
排除标准
- •Participants with known AGAs, including EGFR, ALK, ROS1, NTRK, BRAF, RET, and MET, for which there are approved first-line therapies per local SOC are ineligible. Documented negative results for EGFR, ALK, and ROS1 AGAs are required for participants with non-squamous histology.
- •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, HBV, or 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.
- •Previous systemic anti-tumor therapy including: -Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC. a) (Neo)adjuvant anti-PD-(L)1 is allowed if recurrence or progression occurred ≥9 months after the last dose. b) Other (neo)adjuvant or definitive therapy is allowed if recurrence or progression occurred ≥6 months after the last dose. -Previous treatment with immunotherapy. -Prior radiotherapy to the lung < 6 months of first dose of study intervention. -Palliative local therapy < 2 weeks before the first dose. -Non-specific immunomodulatory therapy < 2 weeks before the first dose. -Prior systemic anti-angiogenic therapy.
- •Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, adverse events from prior immunotherapy not improved to Grade 1 before screening, or required treatment with systemic immunosuppressive therapy.
- •Prior and concomitant therapy: -Therapeutic oral or parenteral anticoagulants or thrombolytic agents < 10 days to the first dose. -Chronic antiplatelet therapy <7 days to randomization. Live or attenuated live vaccine < 4 weeks to the first dose. -Current high-dose systemic corticosteroids. -Prohibited concomitant medication(s) < 21 days to the first dose.
- •Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.
- •Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and/or radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter < 1 cm are permitted.
- •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
- •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 ILD or pneumonitis -Known DLCO (adjusted for hemoglobin) <50% predicted. -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 and arterial/severe venous thromboembolic events.
研究组 & 干预措施
PACLITAXEL
Test
干预措施: PACLITAXEL (Drug)
PF-08634404
Test
干预措施: PF-08634404 (Drug)
SODIUM CHLORIDE
Placebo
干预措施: SODIUM CHLORIDE (Drug)
PEMBROLIZUMAB
Test
干预措施: PEMBROLIZUMAB (Drug)
PEMETREXED
Test
干预措施: PEMETREXED (Drug)
CARBOPLATIN
Test
干预措施: CARBOPLATIN (Drug)
PACLITAXEL ALBUMIN-BOUND
Test
干预措施: PACLITAXEL ALBUMIN-BOUND (Drug)
结局指标
主要结局
Overall survival
Overall survival
PFS using RECIST v1.1 as assessed by BICR
PFS using RECIST v1.1 as assessed by BICR
次要结局
- 1. Key - Confirmed ORR using RECIST v1.1 as assessed by BICR
- 2. PFS using RECIST v1.1 as assessed by investigator; Confirmed ORR using RECIST v1.1 as assessed by investigator; DoR using RECIST v1.1 as assessed by BICR; DoR using RECIST v1.1 as assessed by investigator
- 3. AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s); Laboratory test abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing.
- 4. Predose and postdose concentrations of PF-08634404.
- 5. Incidence of ADA against PF-08634404
- 6. Change from baseline in the global health status/QoL, and Physical function scores on the EORTC QLQ-C30; Change from baseline in dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13; Time to definitive deterioration in the global health status/QoL and physical function scores on the EORTC QLQ-C30; Time to definitive deterioration in dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13
研究者
Clinical Medical Lead
Scientific
Pfizer Inc.
研究点 (125)
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