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

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).