A randomized, multicenter, double-blind, Phase 3 study to investigate the safety and efficacy of belrestotug in combination with dostarlimab compared with placebo in combination with pembrolizumab in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1 selected non small cell lung cancer (GALAXIES LUNG 301)
概览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 13
- 主要终点
- Progression-free survival per RECIST 1.1 by Blinded independent central review
概览
简要总结
Purpose
The purpose of this Phase 3 study is to evaluate the efficacy, safety, PK, and pharmacodynamics of dostarlimab plus belrestotug compared with pembrolizumab plus placebo in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1-high NSCLC.
Hypothesis
This Phase 3 study design is based on the hypothesis that a combination of the anti-PD-1 mAb dostarlimab with the anti-TIGIT mAb belrestotug compared with standard of care (pembrolizumab) will lead to a meaningful improvement in PFS and OS for participants with previously untreated, unresectable, locally advanced or metastatic NSCLC with a high PD-L1 expression (TC ≥50%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply 2)Is capable of giving signed informed consent having age atleast 18 or the legal age of consent in the jurisdiction in which the study is taking place 3)ALocally advanced, unresectable NSCLC (not eligible for curative surgery and/or definitive radiotherapy with or without chemotherapy), or Metastatic NSCLC.
- •Has not received prior systemic therapy.
- •Has a PD-L1-high (TC 50%) tumor as determined by the VENTANA PD-L1(SP263) CDx Assay at a central laboratory.
- •Has an ECOG PS score of 0 or 1 and adequate organ function.
- •If of childbearing potential, female participants must be willing to use contraception.
- •Contraceptive use by female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •A female participant is eligible to participate if she is not pregnant or breastfeeding.
排除标准
- •Participants are excluded from the study if any of the following criteria apply-
- •Has NSCLC with a tumor that harbors any of the following molecular alterations: a.
- •EGFR mutations that are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19, exon 20 insertion mutation, and exon 21 [L858R] substitution mutation).
- •All participants with nonsquamous histology must have been tested for EGFR mutation status using a tissue-based test; use of an approved test is strongly encouraged.
- •Participants with squamous histology do not need to be tested for EGFR mutation status.
- •Participants with nonsquamous histology and unknown or indeterminate EGFR status are excluded.
- •ALK translocations that are sensitive to available targeted inhibitor therapy.
- •All participants with nonsquamous histology must have been tested for ALK fusion mutation status using a tissue-based test; use of an approved test is strongly encouraged.
- •Participants with squamous histology do not need to be tested for ALK fusion mutation status.
- •Any other known genomic aberrations or oncogenic driver mutations for which a locally approved targeted therapy is available for first-line treatment of locally advanced or metastatic NSCLC.
结局指标
主要结局
Progression-free survival per RECIST 1.1 by Blinded independent central review
时间窗: Time point - defined as the time from the date of randomization to the date of first documented Progressive disease or death | due to any cause, whichever comes first
Overall survival
时间窗: Time point - defined as the time from the date of randomization to the date of first documented Progressive disease or death | due to any cause, whichever comes first
次要结局
- To Evaluate Efficacy-(Objective response rate - defined as the percentage of participants with a confirmed Complete response or confirmed Partial Response per RECIST 1.1 by investigator assessment)
- To Evaluate Efficacy-(• Molecular response rate, defined as the percentage of participants with a molecular response)
- To Evaluate Efficacy-(Duration of response per RECIST 1.1 by investigator assessment,)
- To Evaluate Efficacy-(Time to first subsequent therapy)
- To Evaluate Safety(• Incidence of Treatment-emergent adverse events, Serious Adverse Events, & Adverse Events of Special Interest)
研究者
Dr Yogesh Mane
GSK Pharma India Private Limited