Clinical Trials List
2024-08-01 - 2029-09-06
Phase III
Not yet recruiting1
Recruiting5
ICD-10C34.90
Malignant neoplasm of unspecified part of unspecified bronchus or lung
ICD-10C34.91
Malignant neoplasm of unspecified part of right bronchus or lung
ICD-10C34.92
Malignant neoplasm of unspecified part of left bronchus or lung
ICD-10C7A.090
Malignant carcinoid tumor of the bronchus and lung
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
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)
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Trial Applicant
GlaxoSmithKline
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Sponsor
GSK Research & Development Limited
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Chia-I Shen NA
- 蕭慈慧 NA
- YEN-HAN TSENG NA
- Yung-Hung Luo NA
- 江起路 NA
- 趙恒勝 NA
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ying-Ming Tsai Tsai 無
- KUAN-LI WU 無
- 郭家佑 無
- 莊政皓 無
- Inn-Wen Chong 無
- 李玫萱 無
- Chih-Jen Yang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳尚俊 NA
- 黃俊凱 NA
- 廖斌志 NA
- CHAO-CHI HO CHAO-CHI HO NA
- YEN-TING LIN NA
- 許嘉林 NA
- 楊景堯 NA
- 錢穎群 NA
- Jih-Hsiang Lee NA
- 徐偉勛 NA
- James Chih-Hsin Yang NA
- 蔡子修 NA
- Chong-Jen Yu NA
- Chia-Chi Lin NA
- 陳冠宇 NA
- 廖唯昱 NA
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 枋岳甫 NA
- Ping-Chih Hsu NA
- Chih-Liang Wang NA
- 邱立忠 NA
- Chih-Hung Chen NA
- 謝任富 NA
- 林定佑 NA
- Chih-Hsi Kuo NA
- Chien-Ying Liu NA
- 吳教恩 NA
- 柯皓文 NA
- 黃宗楨 NA
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
injection
injection
Active Ingredient
GSK4428859A
Pembrolizumab
Dosage Form
270
270
Dosage
20 mg/mL
100mg/4mL
Endpoints
a. Locally advanced, unresectable NSCLC (not eligible for curative surgery and/or
definitive radiotherapy with or without chemotherapy), or
b. Metastatic NSCLC.
NOTE: Squamous or nonsquamous histology is permitted. Mixed tumors will be
categorized by the predominant cell type; if small cell or neuroendocrine elements
are present, the participant is ineligible.
4. Has not received prior systemic therapy for their locally advanced or metastatic
NSCLC.
NOTE: Completion of treatment with cytotoxic chemotherapy and/or radiation as
part of neoadjuvant/adjuvant therapy is allowed if therapy was completed at least
6 months prior to the diagnosis of locally advanced or metastatic disease. Prior
treatment with neoadjuvant/adjuvant immunotherapy for resectable disease is
permitted if at least 12 months have passed since the last dose of immunotherapy
prior to the diagnosis of locally advanced or metastatic disease and no permanent
discontinuation of prior immunotherapy treatment due to toxicity.
5. Provides a tumor tissue sample obtained at the time of or after the initial diagnosis of
locally advanced or metastatic NSCLC. Although a fresh tumor tissue sample
obtained during screening is preferred, an archival tumor specimen (collected within
2 years prior to screening*) is acceptable. Tumor tissue must be from a site not
previously irradiated. Biopsies obtained prior to the administration of any systemic
therapy administered for the treatment of a participant’s tumor (such as
neoadjuvant/adjuvant therapy) are not acceptable. Needle or excisional biopsies or
resected tissue is required. Cytological specimens such as fine needle aspirates, bone
marrow samples, or cell blocks are not acceptable, nor are bone specimens.
*NOTE: If multiple specimens are available, the most recent archival tumor
specimen should be submitted.
Inclution Criteria
date of randomization to the date of first documented PD or
death due to any cause, whichever comes first
• OS, defined as the time from the date of randomization to the
date of death due to any cause
Exclusion Criteria
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.
b. 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. Participants with nonsquamous histology and
unknown or indeterminate ALK status are excluded.
c. Any other known genomic aberrations or oncogenic driver mutations for which
an approved targeted therapy is available for first-line treatment of locally
advanced or metastatic NSCLC
The Estimated Number of Participants
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Taiwan
20 participants
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Global
1000 participants
