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Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Nelmastobart in Combination With Docetaxel in 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

NCT07306624•STCube, Inc.

View on ClinicalTrials.gov

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

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 treatment including platinum based chemotherapy.

Eligibility

Age

19 - No limit years

Sex

ALL

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
+12 more criteria

Locations (5)

The Catholic University of Korea St. Vincent's Hospital

Gyeonggi-do, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Korea University Anam Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Bundang Hospital

Seoul, South Korea

Key Dates

Start Date

January 10, 2026

Primary Completion Date

August 31, 2027

Completion Date

August 31, 2027

Last Updated

January 15, 2026

Enrollment

ESTIMATED participants

Conditions

Non Small Cell Lung Cancer

Interventions

Nelmastobart and Docetaxel

DRUG

Contacts

Heeyeon Jung

CONTACT

82-2-551-3370 junghy@stcube.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

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