STCube Submits Phase 2 IND for Non-Small Cell Lung Cancer Clinical Trial

STCube, which is developing the BTN1A1 immune checkpoint inhibitor "Nelmastobart," is set to make a full-scale entry into the non-small cell lung cancer (NSCLC) treatment market. NSCLC, along with colorectal cancer, is a representative cancer type with high BTN1A1 expression and a significant unmet need for immuno-oncology therapies.

On August 25, STCube announced that it has submitted a Phase 2 clinical trial protocol (IND) to the Ministry of Food and Drug Safety to evaluate the safety and efficacy of Nelmastobart in combination with docetaxel in patients with advanced or metastatic NSCLC.

The company voluntarily withdrew its previously approved Phase 1b/2 clinical trial plans for relapsed or refractory extensive-stage small cell lung cancer, which had been authorized by both the U.S. Food and Drug Administration (FDA) and the Korean Ministry of Food and Drug Safety. STCube decided to focus on indications for NSCLC and colorectal cancer, where biomarker-driven clinical design can be more effectively implemented and verification as a novel immuno-oncology target can be smoothly pursued.

The NSCLC clinical trial targets patients who have received first-line targeted therapy or platinum-based chemotherapy and immunotherapy, but require second-line or later treatments. The trial will enroll patients with BTN1A1-positive expression (tumor proportion score [TPS] ≥ 50%). A total of 62 patients will be recruited across seven hospitals in Korea, including Samsung Medical Center.

The primary efficacy endpoint is progression-free survival (PFS), while secondary endpoints include overall survival (OS), objective response rate (ORR), disease control rate (DCR), and duration of response (DOR). The company also plans to conduct exploratory analyses of efficacy based on patient characteristics such as BTN1A1 expression levels and the presence of genomic mutations.

NSCLC accounts for approximately 85% of all lung cancers. Various targeted therapies are recommended depending on genetic mutations. For patients without major genetic mutations, the standard of care is determined by the level of PD-L1 expression, with either immune checkpoint inhibitor monotherapy or combination with cytotoxic chemotherapy. Typically, immunotherapy accounts for 60% of treatments, targeted therapy for 30%, and chemotherapy for 10%.

According to STCube, the BTN1A1 expression rate in NSCLC is 84% in squamous cell carcinoma and 45% in adenocarcinoma, based on patients with TPS of 50% or higher. This makes NSCLC a cancer type where patient selection and efficacy validation for biomarker-driven trials are relatively straightforward.

Jung Hyunjin, CEO of STCube, stated, "Our clinical strategy is to select a group of patients with a high likelihood of response, based on the clear biomarker criterion of BTN1A1 expression, even among those who have failed standard treatments. From patient selection to combination regimen design, the trial is structured from the outset with global clinical development and technology transfer potential in mind."

He added, "A biomarker-driven clinical strategy is one of the most important factors evaluated by global pharmaceutical companies during technology transfer negotiations, and it will serve as a catalyst to substantially enhance partnership opportunities and bargaining power. Taking into account the market potential, clinical efficiency, and competitive landscape of Nelmastobart, we have decided to shift the indication to NSCLC."

This content was produced with the assistance of AI translation services.