Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer

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 Criteria:

* 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 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).

Conditions3

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