Actively Recruiting
Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer
Led by STCube, Inc. · Updated on 2026-01-15
62
Participants Needed
5
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed stage IIIb, IIIc, or IV recurrent non-squamous NSCLC
- BTN1A1 TPS score 50
- Patients with positive AGA progressed after at least 1 platinum-based chemotherapy and/or immunotherapy and at least 1 locally approved targeted therapy suitable for AGA
- Patients with negative AGA progressed after prior PD1/PDL therapy and/or platinum-based chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Adequate organ function as described in the protocol
- Adequate cardiac function as described in the protocol
- Agree to use contraception throughout the study and for at least 5 months after last dose if of reproductive potential
- Life expectancy of at least 3 months
- Agreed to provide archival tissue
You will not qualify if you...
- Known allergy to study drug ingredients or excipients
- Previous use of Docetaxel for palliative therapy
- Cytotoxic chemotherapy or oral targeted therapy within 14 days before study
- Investigational drugs within 5 half-lives
- Monoclonal antibodies or ADCs within 4 weeks
- Use or expected use of strong CYP3A4 inhibitors within 14 days before first dose
- Uncontrolled severe infection requiring IV treatment or suspected infection/fever
- Need for continuous high-dose steroids (>10 mg/day prednisone equivalent) or immunosuppressants within 7 days (excluding Docetaxel premedication; intermittent allowed)
- Pregnant or breastfeeding
- Autoimmune disease needing systemic treatment within last 2 years
- Active or unstable CNS lesions
- Stroke, unstable angina, MI, or severe heart symptoms within 6 months
- High blood pressure above specified limits or hypertensive encephalopathy
- History of interstitial lung disease or active pneumonia at screening
- Prior allogeneic stem cell or organ transplant
- Live or attenuated live vaccine within 30 days
- Other cancers besides NSCLC
- Not recovered from prior cancer therapy side effects to Grade 1 or better
- 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 surgery
- Active hepatitis B, C, or HIV infection (carriers with negative viral load may be eligible)
- Clinically unstable pleural or peritoneal effusion (stable after intervention allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
The Catholic University of Korea St. Vincent's Hospital
Gyeonggi-do, South Korea
Not Yet Recruiting
2
Kangbuk Samsung Hospital
Seoul, South Korea
Actively Recruiting
3
Korea University Anam Hospital
Seoul, South Korea
Not Yet Recruiting
4
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
5
Seoul National University Bundang Hospital
Seoul, South Korea
Not Yet Recruiting
Research Team
H
Heeyeon Jung
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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