Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)
Lung Cancer
Unknown Primary
18 Years and older, Male and Female
2870-004 (primary)
NCI-2024-06516
2023-503539-16
2023-503539-16-00
jRCT2031240108
U1111-1287-4913
Summary
The purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapy
(docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung
cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as
EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene
rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14
skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20
S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypotheses are that
sacituzumab tirumotecan is: (1) superior to chemotherapy with respect to progression-free
survival (PFS) per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations; and (2)
superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR
mutations.
Eligibility
- Histologically- or cytologically-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations.
- Documentation of locally assessed radiological disease progression while on or after last treatment based on Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1.
- Participants with genome mutations must have received 1 or 2 prior lines of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), including a third generation TKI for participants with a T790M mutation; and 1 platinum-based therapy after progression on or after EGFR TKI.
- Measurable disease per RECIST 1.1 as assessed by the local site investigator.
- Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
- Participants who have AEs due to previous anticancer therapies must have recovered to Grade =1 or baseline.
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
- Have an ECOG performance status of 0 or 1 within 3 days before randomization.
Treatment Sites in Georgia
340 Kennestone Hospital Blvd.
Suite 100
Marietta, GA 3060
Study Coordinator:
Kristine Parker
470-267-1480
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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