Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer

A Multicenter, Phase 2 Clinical Trial Based on an Adaptive Design to Evaluate the Safety and Efficacy of Nelmastobart in Combination With Docetaxel in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer Who Are Resistant or Intolerant to Platinum-based Chemotherapy and/or Immunotherapy

A Multicenter, Phase 2 Clinical Trial Based on an Adaptive Design to Evaluate the Safety and Efficacy of Nelmastobart in Combination with Docetaxel in Patients with Advanced/Metastatic Non-Small Cell Lung Cancer Who Are Resistant or Intolerant to Platinum-based Chemotherapy and/or Immunotherapy

Study Overview

• Status: Recruiting
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Nelmastobart and Docetaxel

Detailed Description

This is a singble arm, open label, phase 2 study to evaluate safety and preliminary efficacy for Nelmastobart 800mg and docetaxel 75mg/m2 combination regimen for both AGA negative and positive NSCLC patients who have failed at least 1 line of treatment including platinum based chemotherapy.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Heeyeon Jung; Phone Number: 82-2-551-3370; Email: junghy@stcube.com

Study Locations

• South Korea
  • Gyeonggi-do, South Korea
    • Not yet recruiting
    • The Catholic University of Korea St. Vincent's Hospital
    • Principal Investigator: Byoung-Yong Shim, M.D, Ph.D
  • Seoul, South Korea
    • Recruiting
    • Samsung Medical Center
    • Principal Investigator: Sehoon Lee, M.D, Ph.D
  • Seoul, South Korea
    • Recruiting
    • Kangbuk Samsung Hospital
    • Principal Investigator: Yun-Gyoo Lee, M.D, Ph.D
  • Seoul, South Korea
    • Not yet recruiting
    • Korea University Anam Hospital
    • Principal Investigator: Yoonji Choi, M.D, Ph.D
  • Seoul, South Korea
    • Not yet recruiting
    • Seoul National University Bundang Hospital
    • Principal Investigator: Yu-Jeong Kim, M.D, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically or cytologically confirmed stage IIIb, IIIc, or IV 4 recurrent non-squamous NSCLC
• BTN1A1 TPS score ≥50
• Subjects with positive AGA must have progressed after At least 1 platinum-based chemotherapy and/or immunotherapy AND at least 1 locally approved targeted therapy appropriate to the AGA
• Subjects with negative AGA must have progressed after prior PD1/ (PDL therapy and/or platinum-based chemotherapy
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0- 1.
• Adequate organ function as described in the protocol
• Adequate cardiac function as described in the protocol
• For female or male patients with reproductive potential: Agree to use contraception throughout the study and at least 5 months after the last dose.
• Life expectancy of at least 3 months
• Has agreed to provide archival tissue

Exclusion Criteria:

• Known hypersensitivity to the active ingredients or excipients of the study drug.
• History of using Docetaxel for palliative therapy.
• Prior treatment with Cytotoxic chemotherapy or oral targeted therapy within 14 days.
• Investigational drugs within 5 half-lives.
• Monoclonal antibodies or ADCs within 4 weeks.
• Use or expected use of strong CYP3A4 inhibitors (e.g., ketoconazole) within 14 days prior to the first dose.
• Uncontrolled severe infection requiring IV treatment, or suspected infectious complications/fever.
• Requirement for continuous high-dose steroids (>10 mg/day prednisone equivalent) or immunosuppressants within 7 days (excluding Docetaxel premedication; intermittent/replacement therapies allowed).
• Pregnant or breastfeeding women.
• History of autoimmune disease requiring systemic treatment within the last 2 years
• Known active symptomatic or radiologically unstable CNS lesions
• History of stroke, unstable angina, MI, or NYHA Class III-IV symptoms within 6 months, or current Class II.
• Systolic BP 160 mmHg or Diastolic BP 100 mmHg, or hypertensive encephalopathy.
• History of ILD, organizing/drug-induced pneumonia, or active pneumonia on screening (mild asymptomatic fibrosis requires consultation).
• Recipients of allogeneic stem cell or solid organ transplants.
• Vaccination with live or attenuated live vaccines within 30 days.
• Maligancies other than NSCLC
• Failure to recover from prior anti-cancer therapy side effects to CTCAE Grade 1
• Wide-field bone marrow radiation (>30%) within 4 weeks, or limited palliative radiation within 2 weeks.
• Major surgery within 4 weeks or incomplete recovery from surgical side effects.
• Evidence of active HBV, HCV, or HIV infection (carriers with negative viral loads/RNA may be eligible).
• Clinically unstable pleural or peritoneal effusion (stable cases after intervention are allowed).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nelmastobart 800mg+Docetaxel 75mg/m2; Nelmastobart 800mg+Docetaxel 75mg/m2 fixed	Drug: Nelmastobart and Docetaxel; Nelmastobart 800mg and Docetaxel 75mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival by central reviewer	Time from first dose until the date of objective disease progression or death assessed by central reviewer	up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum plasma concentration	3 weeks
Overall survival	Time from first dose of study drug until the date of death	up to 3 years
Progression Free Survival assessed by Investigator	Time from first dose until the date of objective disease progression or death	Up to 3 years
Disease control rate, DCR	Proportion of subjects with confirmed CR, PR, and SD assessed by investigator and central reviewer based on RECIST v1.1	Up to 3 years
Progression free survival rate	the proportion of patients without documented progression and alive 6 months after the first dose of study drug	6 month
Area under concentration-time curve	Area under the concentration-time curve during steady state	15 weeks
Adverse event	Incidence and severity of AE determined according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version [v] 5.0	time from the date of the first dose of study drug until 30 days after last dose
Objective response rate, ORR	Proportional of subjects with confirmed PR/CR, assessed by investigator and central reviewer	Up to 3 years
Duration of Response	Time from the date of first objective response (CR or PR) after investigational drug administration to the first documented disease progression (PD) or death from any cause, with documentation of disease progression status and cause of death, assessed by investigator and central reviewer based on RECIST v1.1	Up to 3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life measured by EQ-5D-5L	Change from Baseline in Patient Reported Outcome EQ-5D-5L at Treatment Cycle 2 and beyond	until the end of treatment (Up to 3 years)

Collaborators and Investigators

• Sponsor: STCube, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): January 10, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: December 14, 2025
• First Submitted That Met QC Criteria: December 14, 2025
• First Posted (Estimated): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: nsclc; BTN1A1; immune check point inhibitor
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Docetaxel
• Other Study ID Numbers: STCUBE-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No