Nelmastobart plus docetaxel for advanced non-small cell lung cancer

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

This trial tests nelmastobart combined with docetaxel in people with advanced non-small cell lung cancer who are resistant or intolerant to platinum chemotherapy or immunotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: STCube, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, prednisone
• Locations: 5 sites (Gyeonggi-do and 4 other locations)
• Trial ID: NCT07306624 on ClinicalTrials.gov

What this trial studies

This is an open-label, single-arm Phase 2 trial with an adaptive design testing nelmastobart (800 mg) plus docetaxel (75 mg/m2) in patients with advanced or metastatic non-squamous NSCLC who have failed prior platinum-based chemotherapy and/or immunotherapy. Enrollment includes cohorts defined by AGA biomarker status, with protocol-specified BTN1A1 thresholds, and requires ECOG 0–1 and adequate organ and cardiac function. The trial's primary focus is safety and preliminary efficacy, using response rates and progression-free survival as key outcomes and applying interim adaptive rules to guide enrollment. Archival tumor tissue is required for biomarker testing and patients are followed for adverse events and tumor response per protocol.

Who should consider this trial

Good fit: Adults with advanced or metastatic non-squamous NSCLC who have ECOG 0–1, adequate organ and cardiac function, archival tumor tissue, and progression after at least one line of platinum-based chemotherapy and/or immunotherapy (meeting the trial's BTN1A1/AGA biomarker criteria) are the intended candidates.

Not a fit: Patients with squamous histology, poor performance status (ECOG ≥2), significant organ or cardiac dysfunction, known hypersensitivity to the study drugs, or who do not meet the biomarker or prior-treatment requirements are unlikely to benefit.

Why it matters

Potential benefit: If successful, the combination could offer a new second-line option that prolongs disease control for patients whose cancer no longer responds to standard platinum chemotherapy or immunotherapy.

How similar studies have performed: Combining novel targeted or immune-modulating agents with docetaxel has shown activity in relapsed NSCLC in other trials, but nelmastobart itself is a novel agent with limited prior clinical data.

Eligibility criteria

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).

Where this trial is running

Gyeonggi-do and 4 other locations

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

Study contacts

• Study coordinator: Heeyeon Jung

Conditions Non Small Cell Lung Cancer; BTN1A1; nsclc; immune check point inhibitor