Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer

NCT07306624 | Recruiting Phase 2

• 1 other identifier: STCUBE-004
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Non Small Cell Lung Cancer

Keywords

BTN1A1; nsclc; immune check point inhibitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Overall survival

  up to 3 years

• Progression Free Survival assessed by Investigator

  Up to 3 years

• Objective response rate, ORR

  Up to 3 years

• Disease control rate, DCR

  Up to 3 years

• Duration of Response

  Up to 3 years

Other Outcomes (1)

• Quality of life measured by EQ-5D-5L

  until the end of treatment (Up to 3 years)

Study Arms (1)

Nelmastobart 800mg+Docetaxel 75mg/m2

EXPERIMENTAL

Nelmastobart 800mg+Docetaxel 75mg/m2 fixed

Drug: Nelmastobart and Docetaxel

Interventions

Nelmastobart and Docetaxel DRUG

Nelmastobart 800mg and Docetaxel 75mg/m2

Nelmastobart 800mg+Docetaxel 75mg/m2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• STCube, Inc.: lead

Study Sites (5)

The Catholic University of Korea St. Vincent's Hospital

Gyeonggi-do, South Korea

NOT YET RECRUITING

Kangbuk Samsung Hospital

Seoul, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, South Korea

NOT YET RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seoul, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Heeyeon Jung

CONTACT

82-2-551-3370; junghy@stcube.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 29, 2025
• Study Start: January 10, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)