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
STCube, Inc.
62 participants
Jan 10, 2026
INTERVENTIONAL
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
Eligibility
Inclusion Criteria10
- 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 Criteria22
- 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).
Interventions
Nelmastobart 800mg and Docetaxel 75mg/m2
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT07306624