Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer

Prior treatment

• 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.
• Requirement for continuous high-dose steroids (\>10 mg/day prednisone equivalent) or immunosuppressants within 7 days (excluding Docetaxel premedication; intermittent/replacement therapies allowed).
• Vaccination with live or attenuated live vaccines within 30 days.
• 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.

Other illness

• Known hypersensitivity to the active ingredients or excipients of the study drug.
• History of using Docetaxel for palliative therapy.
• Uncontrolled severe infection requiring IV treatment, or suspected infectious complications/fever.
• History of autoimmune disease requiring systemic treatment within the last 2 years
• History of stroke, unstable angina, MI, or NYHA Class III-IV symptoms within 6 months, or current Class II.
• History of ILD, organizing/drug-induced pneumonia, or active pneumonia on screening (mild asymptomatic fibrosis requires consultation).
• Evidence of active HBV, HCV, or HIV infection (carriers with negative viral loads/RNA may be eligible).

Other

• Pregnant or breastfeeding women.
• Known active symptomatic or radiologically unstable CNS lesions
• Systolic BP 160 mmHg or Diastolic BP 100 mmHg, or hypertensive encephalopathy.
• Recipients of allogeneic stem cell or solid organ transplants.
• Maligancies other than NSCLC
• Clinically unstable pleural or peritoneal effusion (stable cases after intervention are allowed).

• 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