A Phase 3 study of belrestotug plus dostarlimab compared with placebo plus pembrolizumab in previously untreated PD-L1 high NSCLC

JRCT ID: jRCT2051240051

Registered date:04/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Non-small-cell lung cancer
• Date of first enrollment: 03/06/2024
• Target sample size: 1000
• Countries of recruitment: Spain,Japan,United State,Japan,Poland,Japan,France,Japan,Brazil,Japan,Germany,Japan,Korea,Japan,Italy,Japan,China,Japan,Argentina,Japan,Sweden,Japan,Belgium,Japan,Finland,Japan,Netherlands,Japan,Canada,Japan,Hong Kong,Japan,Thailand,Japan,Hungary,Japan,Taiwan,Japan,Mexico,Japan,Czechia,Japan,Portugal,Japan,Philippines,Japan,Turkey,Japan,Greece,Japan,Serbia,Japan,Panama,Japan,Singapore,Japan,United Kingdom,Japan,India,Japan
• Study type: Interventional

Intervention(s)

Dostarlimab
Belrestotug
Pembrolizumab
Placebo (normal saline)

Outcome(s)

Primary Outcome

-PFS by BICR
-OS

Secondary Outcome

-ORR
-MRR
-PFS by investigator assessment
-DOR
-TFST
-Safety
-Immunogenicity

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Ishibashi Hideyasu