Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer

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Status and phase

Enrolling

Phase 2

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: Nelmastobart and Docetaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT07306624

STCUBE-004

Details and patient eligibility

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

Full description

This is a singble arm, open label, phase 2 study to evaluate safety and preliminary efficacy for Nelmastobart 800mg and docetaxel 75mg/m2 combination regimen for both AGA negative and positive NSCLC patients who have failed at least 1 line of treatment including platinum based chemotherapy.

Enrollment

62 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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).