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| Overall Recruitment Status: Active, not yet recruiting |
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| Official Title |
| 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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| Region |
Sponsors |
| Hawaii |
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| Acronym |
NCT No. |
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NCT06472076 |
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| Study Type |
Phase |
| Clinical Trial |
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| Purpose |
| The goal of this clinical trial is to evaluate the efficacy and safety profile of dostarlimab in combination with belrestotug when compared with pembrolizumab and placebo in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1 high NSCLC. Researchers will compare belrestotug plus dostarlimab with pembrolizumab plus placebo to see if there is meaningful improvement in progression free survival (PFS) and overall survival (OS).
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| Detailed Description |
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- Has a histologically or cytologically confirmed diagnosis of locally 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 for their locally advanced or metastatic NSCLC.
Provides a fresh tumor tissue sample obtained at the time of or after the initial diagnosis of locally advanced or metastatic NSCLC.
Has a PD-L1-high (Tumor cells [TC] =50%) tumor
Has measurable disease (at least 1 target lesion) based on RECIST 1.1
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- Has NSCLC with a tumor that harbors any of the following molecular alterations:
1. Epidermal growth factor receptor (EGFR) mutations that are sensitive to available targeted inhibitor therapy
2. Anaplastic lymphoma kinase (ALK) translocations that are sensitive to available targeted inhibitor therapy
3. 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.
Has had surgery within 4 weeks of the first dose of study intervention and has not recovered from AEs (i.e., has any ongoing surgery-related events = Grade 1)/complications
related to surgery or has received lung radiation therapy of >30 gray (Gy) within 6 months
Has received prior therapy with any immune checkpoint inhibitors, including antibodies or drugs targeting PD-(L)1, Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), T cell immunoglobulin and ITIM domain (TIGIT), or other checkpoint pathways.
Has never smoked, defined as smoking <100 tobacco cigarettes in a lifetime.
Has an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years, with the exception of those with a negligible risk of metastasis or death and/or treated with expected curative outcome.
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