NCT07306624 Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer
| NCT ID | NCT07306624 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | STCube, Inc. |
| Condition | Non Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2026-01-10 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 62 participants in total. It began in 2026-01-10 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07306624 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07306624 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07306624 currently recruiting?
Yes, NCT07306624 is actively recruiting participants. Contact the research team at junghy@stcube.com for enrollment information.
Where is the NCT07306624 trial being conducted?
This trial is being conducted at Gyeonggi-do, South Korea, Seoul, South Korea, Seoul, South Korea, Seoul, South Korea and 1 additional location.
Who is sponsoring the NCT07306624 clinical trial?
NCT07306624 is sponsored by STCube, Inc.. The trial plans to enroll 62 participants.
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