臨床研究等提出・公開システム

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) (GALAXIES LUNG-301
)

A Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC)
(GALAXIES LUNG-301)

Ishibashi Hideyasu

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

jp.gskjrct@gsk.com

Ishibashi Hideyasu

GlaxoSmithKline K.K.

Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan

+81-120-561-007

jp.gskjrct@gsk.com

Not Recruiting

June. 03, 2024

Interventional

randomized controlled trial

double blind

active control

parallel assignment

treatment purpose

1.Has a histologically or cytologically confirmed diagnosis of 1 of the following:
a. Locally advanced, unresectable NSCLC (not eligible for curative surgery
and/or definitive radiotherapy with or without chemotherapy), or
b. Metastatic NSCLC.
2.Has not received prior systemic therapy for their locally advanced or metastatic
NSCLC.
3.Provides a tumor tissue sample obtained at the time of or after the initial diagnosis of
locally advanced or metastatic NSCLC.
4.Has measurable disease (at least 1 target lesion) based on RECIST 1.1, as determined
by the investigator.
5.Has a PD-L1-high (TC>-50%) tumor as determined by the assay at a central laboratory.
6.Has adequate organ function.

1.Has NSCLC with a tumor that harbors any of the following molecular alterations:
a.EGFR mutations that are sensitive to available targeted inhibitor therapy.
b.ALK translocations that are sensitive to available targeted inhibitor therapy.
c.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.
2.Has had major surgery within 4 weeks of the first dose of study intervention or has received lung radiation therapy of >30Gy within 6months of the first dose of study intervention.
3.Has received prior therapy with any immune checkpoint inhibitors, including antibodies or drugs targeting PD-(L)1, CTLA-4, TIGIT, or other checkpoint pathways.
4.Has never smoked, defined as smoking <100 tobacco cigarettes in a lifetime
5.Has an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years.
6.Has known symptomatic, untreated, or actively progressing brain metastases and/or leptomeningeal disease.
7.Has autoimmune disease or syndrome (current or history thereof) that required systemic treatment within the past 2 years.
8.Has symptomatic ascites or pleural effusion or pericardial effusion.

Both

Non-small-cell lung cancer

Dostarlimab
Belrestotug
Pembrolizumab
Placebo (normal saline)

-Incidence of TEAEs and SAEs
-Incidence of TEAEs/SAEs leading to dose withdrawals or treatment discontinuations

+81-72-445-1000

Mar. 19, 2024

No

Spain/United States/Poland/France/Brazil/Germany/Korea/Italy/China/Argentina/Sweden/Belgium/Finland/Netherlands/Canada/Hong Kong/Thailand/Hungary/Taiwan/Mexico/Czechia/Portugal/Philippines/Turkey/Greece/Serbia/Panama/Singapore/United Kingdom/India