Nelmastobart plus docetaxel for advanced non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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).

Where it's running

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

Study contacts

• Study coordinator: Heeyeon Jung
• Email: junghy@stcube.com
• Phone: 82-2-551-3370

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.