Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
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 or STK11 mutated, non-squamous, non-small cell lung cancer.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 2 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jul 21, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Synthekine
- Interventions being studied
- Drug: STK-012; Drug: pembrolizumab KEYTRUDA®; Drug: pemetrexed; Drug: carboplatin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Selected 1. Phase 1: Selected advanced solid tumors 2. Phase 2:
- Diagnosis of non-small cell lung cancer (NSCLC).
- Stage IV or Stage IIIB/IIIC and not a candidate for definitive treatment.
- Non-squamous (NSQ) cell histology.
- No prior systemic therapy for advanced/metastatic NSQ NSCLC.
- Must have a tumor that meets at least one of the following criteria on local testing:
- PD-L1 negative (TPS \<1%), OR;
- STK11 mutated on tumor tissue or ctDNA
- No known actionable EGFR, ALK, ROS1, or other actionable genomic aberrations for which there is a local standard of care available as front line therapy. Selected
- 2\. Phase 2:
- Prior immune checkpoint inhibitor (anti-PD\[L\]1 and/or anti-CTLA-4) treatment
- Rare tumor subtypes (mucinous histology or tumors with small cell, neuroendocrine, or sarcomatoid components).
- Received radiotherapy ≤ 7 days of the first dose of study treatment.
- Known active central nervous system metastases
- Any history of carcinomatous meningitis
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Arizona Cancer CenterTucson, Arizona
- Beverly Hills Cancer CenterBeverly Hills, California
- Providence Medical FoundationFullerton, California
- UC San Diego Moores Cancer CenterLa Jolla, California
- Cedars SinaiLos Angeles, California
- Hoag Memorial Hospital PresbyterianNewport Beach, California
- UCLA Hematology/Oncology - Santa MonicaSanta Monica, California
- Yale New Haven Hospital, Yale Cancer CenterNew Haven, Connecticut
- Georgetown UniversityWashington D.C., District of Columbia
- Winship Cancer Institute, Emory UniversityAtlanta, Georgia
- University of ChicagoChicago, Illinois
- University of MarylandBaltimore, Maryland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 21, 2026. Always confirm current availability with the study team.