Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]
Lung Cancer
Unknown Primary
18 Years and older, Male and Female
2870-023 (primary)
NCI-2025-00211
2023-510128-66
2023-510128-66-00
jRCT2021240015
MK-2870-023
U1111-1301-2790
Summary
This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane
(paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance
sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous
non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance
sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan
maintenance with respect to overall survival (OS).
Objectives
All participants undergo an initial induction phase of four cycles, each cycle consisting
of pembrolizumab q3w + carboplatin q3w + paclitaxel q3w or nabpaclitaxel weekly.
Participants are then randomly assigned to pembrolizumab maintenance vs. pembrolizumab +
sac-TMT maintenance.
Eligibility
- Histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) [Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8]
- Measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the local site investigator/radiology
- Has life expectancy =3 months
- Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 assessed within 7 days prior to allocation
- Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Participants who are hepatitis B surface antigen (HBsAg)-positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to = Grade 1 or baseline (participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible)
- Has adequate organ function
- For Maintenance only (prior to randomization): is without disease progression of their NSCLC, as determined by BICR using RECIST 1.1 after completion of study-specified Induction with an evaluable scan at Week 12
- For Maintenance only (prior to randomization): has ECOG PS of 0 or 1 as assessed at the Prerandomization Visit
- For Maintenance only (prior to randomization): all AEs (with the exception of alopecia, Grade 2 fatigue, and Grade =2 endocrine-related AEs requiring treatment or hormone replacement) have recovered
Treatment Sites in Georgia
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