Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: STK-012, pembrolizumab KEYTRUDA®, pemetrexed, carboplatin.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumor, Non Small Cell Lung Cancer, Untreated Advanced NSCLC, 1st Line NSCLC. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Georgia, Ireland, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1/2 Study to Evaluate STK-012 as a Single Agent and in Combination Therapy in Subjects With Front-line Advanced NSCLC and Other Selected Indications
Overview
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.
Detailed description
Phase 1: The phase 1a portion is a dose escalation study to evaluate STK-012 as monotherapy and in combination therapy in patients with selected solid tumors. The phase 1b portion is a dose expansion study to evaluate STK-012 as monotherapy and in combination therapy at the candidate recommended phase 2 dose (RP2D) in selected solid tumor types.
Phase 2: The phase 2 portion is a randomized, open label study to evaluate STK-012 at two dose levels 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. Subjects in the randomized Phase 2 portion (Part G) will be randomized 1:1:1 and stratified by tumor PD-L1 expression and STK11 mutation status.
Interventions
- Drug STK-012
Engineered Interleukin-2 (IL-2) selective for antigen activated T cells - Drug pembrolizumab KEYTRUDA®
anti-PD-1 monoclonal antibody - Drug pemetrexed
chemotherapy - Drug carboplatin
chemotherapy
Primary outcome measures
- Phase 1a: Treatment emergent adverse events (TEAEs) [Time frame: From 1st dose of study treatment through 90 days after last dose]
- Phase 1a: Serious adverse events (SAEs) [Time frame: From 1st dose of study treatment through 90 days after last dose]
- Phase 1a: Dose limiting toxicities (DLTs) [Time frame: Cycle 1, Days 1 through 21]
- Phase 1a: Deaths [Time frame: From 1st dose of study treatment until death, up to 4 years]
- Phase 1b: TEAEs at the RP2D [Time frame: From 1st dose of study treatment through 90 days after last dose]
- Phase 1b: SAEs at the RP2D [Time frame: From 1st dose of study treatment through 90 days after last dose]
- Phase 1b: Deaths at the RP2D [Time frame: From 1st dose of study treatment until death, up to 4 years]
- Phase 2: Overall response rate (ORR) in Arm A versus Arm C [Time frame: From randomization until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years]
Secondary outcome measures (12)
- Phase 1: ORR [Time frame: From enrollment until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years]
- Phase 1: Progression free survival (PFS) [Time frame: From enrollment until first documentation of disease progression per investigator assessment or death due to any cause, whichever occurs first, up to 4 years]
- Phase 1: Overall survival (OS) [Time frame: From enrollment until death due to any cause, up to 4 years]
- Phase 1/2: STK-012 ADAs [Time frame: From screening through 30 days after last dose of STK-012]
- Phase 1/2: AUC of STK-012 [Time frame: From screening through 30 days after last dose of STK-012]
- Phase 1/2: Cmax of STK-012 [Time frame: From screening through 30 days after last dose of STK-012]
- Phase 1/2: Tmax of STK-012 [Time frame: From screening through 30 days after last dose of STK-012]
- Phase 1/2: Half life of STK-012 [Time frame: From screening through 30 days after last dose of STK-012]
- Phase 2: PFS in Arm A versus Arm C [Time frame: From randomization until first documentation of disease progression per BICR or death due to any cause, whichever occurs first, up to 4 years]
- Phase 2: ORR in Arm B versus Arm C [Time frame: From randomization until disease progression or death, or the last evaluable assessment in the absence of progression, up to 4 years]
- Phase 2: PFS in Arm B versus Arm C [Time frame: From randomization until first documentation of disease progression per BICR or death due to any cause, whichever occurs first, up to 4 years]
- Phase 2: OS in Arm A versus C [Time frame: From randomization until death due to any cause, up to 4 years]
Eligibility criteria
Selected Inclusion Criteria:
- Phase 1: Selected advanced solid tumors
- 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 Exclusion Criteria:
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 33 centers
- University of Arizona Cancer Center — Tucson
- Beverly Hills Cancer Center — Beverly Hills
- Providence Medical Foundation — Fullerton
- UC San Diego Moores Cancer Center — La Jolla
- Cedars Sinai — Los Angeles
- Hoag Memorial Hospital Presbyterian — Newport Beach
- UCLA Hematology/Oncology - Santa Monica — Santa Monica
- Yale New Haven Hospital, Yale Cancer Center — New Haven
- … and 25 more centers
Spain · 6 centers
- Hospital Quirón Barcelona — Barcelona
- START Rioja — Logroño
- MD Anderson — Madrid
- Hospital Universitario Ramon y Cajal — Madrid
- Hospital Regional de Málaga — Málaga
- Clinica Universidad de Navarra - Pamplona — Pamplona
Georgia · 4 centers
- LTD High Technology Hospital Medcenter — Batumi
- Caraps Medline, Ltd (JSC VIAN) — Tbilisi
- Institute of Clinical Oncology (ICO) — Tbilisi
- Israel Georgian Medical Research Clinic Healthycore — Tbilisi
Ireland · 4 centers
- START Dublin — Dublin
- St. James Hospital — Dublin
- Beaumont Hospital — Dublin
- University Hospital Galway — Galway
Identifiers
NCT: NCT05098132 · STK-012-101 · 2025-522632-14-00 · KEYNOTE-G63 · MK-3475-G63