Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer

Official title

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

Overview

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

Detailed 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 platinum based chemotherapy.

Interventions

• Drug Nelmastobart and Docetaxel
  Nelmastobart 800mg and Docetaxel 75mg/m2

Primary outcome measures

• Progression free survival by central reviewer [Time frame: up to 3 years]

Secondary outcome measures (9)

• Overall survival [Time frame: up to 3 years]
• Progression Free Survival assessed by Investigator [Time frame: Up to 3 years]
• Objective response rate, ORR [Time frame: Up to 3 years]
• Disease control rate, DCR [Time frame: Up to 3 years]
• Duration of Response [Time frame: Up to 3 years]
• Progression free survival rate [Time frame: 6 month]
• Cmax [Time frame: 3 weeks]
• Area under concentration-time curve [Time frame: 15 weeks]
• Adverse event [Time frame: time from the date of the first dose of study drug until 30 days after last dose]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

South Korea · 5 centers

• The Catholic University of Korea St. Vincent's Hospital — Gyeonggi-do
• Kangbuk Samsung Hospital — Seoul
• Korea University Anam Hospital — Seoul
• Samsung Medical Center — Seoul
• Seoul National University Bundang Hospital — Seoul

Identifiers

NCT: NCT07306624 · STCUBE-004

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗