Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer

July 14, 2026 updated by: STCube, Inc.

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

Intervention / Treatment

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 platinum based chemotherapy.

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Gyeonggi-do, South Korea
        • 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
        • Seoul National University Bundang Hospital
        • Principal Investigator:
          • Yu-Jeong Kim, M.D, Ph.D
      • Seoul, South Korea
        • Recruiting
        • Korea University Anam Hospital
        • Principal Investigator:
          • Yoonji Choi, M.D, Ph.D
      • Seoul, South Korea
        • Recruiting
        • Kangbuk Samsung Hospital
        • Principal Investigator:
          • Yun-Gyoo Lee, M.D, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 recurrent 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 at least 1platinum-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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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 Frame: up to 3 years
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
Time Frame: 3 weeks
Maximum plasma concentration
3 weeks
Overall survival
Time Frame: up to 3 years
Time from first dose of study drug until the date of death
up to 3 years
Progression Free Survival assessed by Investigator
Time Frame: Up to 3 years
Time from first dose until the date of objective disease progression or death
Up to 3 years
Disease control rate, DCR
Time Frame: Up to 3 years
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
Time Frame: 6 month
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
Time Frame: 15 weeks
Area under the concentration-time curve during steady state
15 weeks
Adverse event
Time Frame: time from the date of the first dose of study drug until 30 days after last dose
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
Time Frame: Up to 3 years
Proportional of subjects with confirmed PR/CR, assessed by investigator and central reviewer
Up to 3 years
Duration of Response
Time Frame: Up to 3 years
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
Time Frame: until the end of treatment (Up to 3 years)
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

This is where you will find people and organizations involved with this study.

Sponsor

STCube, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

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 (Actual)

December 29, 2025

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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