Actively Recruiting
Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
Led by Synthekine · Updated on 2026-03-18
364
Participants Needed
27
Research Sites
361 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase 1/2, multicenter, open-label study. The phase 1 portion is a dose escalation and expansion study of STK-012 as monotherapy and in combination therapy in patients with selected advanced solid tumors. The phase 2 portion is a randomized study of STK-012 in combination with standard of care (SoC) pembrolizumab, pemetrexed, and carboplatin versus SoC, in patients with first line, PD-L1 negative, non-squamous, non-small cell lung cancer.
CONDITIONS
Official Title
Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of non-small cell lung cancer (NSCLC)
- Stage IV or Stage IIIB/IIIC NSCLC and not a candidate for definitive treatment
- Non-squamous cell histology
- No prior systemic therapy for advanced/metastatic non-squamous NSCLC
- Tumor is PD-L1 negative (TPS <1%) by local testing
- No known actionable EGFR, ALK, ROS1, or other genomic aberrations with available standard first-line therapy
You will not qualify if you...
- Prior treatment with immune checkpoint inhibitors (anti-PD[L]1 and/or anti-CTLA-4)
- Tumor contains small cell, neuroendocrine, or sarcomatoid components
- Received radiotherapy within 7 days before the first dose of study treatment
- Known untreated central nervous system metastases
- History of carcinomatous meningitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
University of Arizona Cancer Center
Tucson, Arizona, United States, 85721
Actively Recruiting
2
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
Actively Recruiting
3
Providence Medical Foundation
Fullerton, California, United States, 92835
Actively Recruiting
4
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093-0698
Active, Not Recruiting
5
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
6
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States, 90404
Actively Recruiting
7
Yale New Haven Hospital, Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
8
Georgetown University
Washington D.C., District of Columbia, United States, 20057
Actively Recruiting
9
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
10
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
11
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
12
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
13
HealthPartners Cancer Center at Regions Hospital
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
14
Northwell Health
Lake Success, New York, United States, 11042
Actively Recruiting
15
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
16
Columbia University Irving Medical Center
New York, New York, United States, 10032
Active, Not Recruiting
17
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
18
Duke Cancer Center
Durham, North Carolina, United States, 27710
Actively Recruiting
19
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43210
Actively Recruiting
20
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Active, Not Recruiting
21
Baptist Memorial Hospital Cancer Center
Memphis, Tennessee, United States, 38120
Actively Recruiting
22
Sarah Cannon Research Institute - Nashville
Nashville, Tennessee, United States, 37203
Active, Not Recruiting
23
Renovatio Clinical
El Paso, Texas, United States, 79915
Withdrawn
24
Oncology Consultants
Houston, Texas, United States, 77303
Actively Recruiting
25
Renovatio Clinical
The Woodlands, Texas, United States, 77380
Withdrawn
26
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
27
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Actively Recruiting
Research Team
S
Synthekine STK-012-101 Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
9
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