Non Small Cell Lung CancerPhase 2NCT07306624
Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer
A Phase 2 study testing Nelmastobart and Docetaxel in people with Non Small Cell Lung Cancer, run by STCube, Inc. at 5 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Nelmastobart and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 10 Jan 2026to 31 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
South Korea5 sites, 5 recruiting
- Recruiting
The Catholic University of Korea St. Vincent's Hospital
Gyeonggi-do
Byoung-Yong Shim, M.D, Ph.D
- Recruiting
Kangbuk Samsung Hospital
Seoul
Yun-Gyoo Lee, M.D, Ph.D
- Recruiting
Korea University Anam Hospital
Seoul
Yoonji Choi, M.D, Ph.D
- Recruiting
Samsung Medical Center
Seoul
Sehoon Lee, M.D, Ph.D
- Recruiting
Seoul National University Bundang Hospital
Seoul
Yu-Jeong Kim, M.D, Ph.D
About this study
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
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
Read the 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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Nelmastobart and Docetaxel
- Keywords
- BTN1A1, nsclc, immune check point inhibitor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nelmastobart and DocetaxelDrug
Nelmastobart 800mg and Docetaxel 75mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Nelmastobart 800mg+Docetaxel 75mg/m2 | Experimental | Nelmastobart 800mg+Docetaxel 75mg/m2 fixed Receives: Drug: Nelmastobart and Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival by central reviewer
Time from first dose until the date of objective disease progression or death assessed by central reviewer
Measured: up to 3 years
Secondary outcomes (9)
Overall survival
Time from first dose of study drug until the date of death
Measured: up to 3 years
Progression Free Survival assessed by Investigator
Time from first dose until the date of objective disease progression or death
Measured: Up to 3 years
Objective response rate, ORR
Proportional of subjects with confirmed PR/CR, assessed by investigator and central reviewer
Measured: Up to 3 years
Disease control rate, DCR
Proportion of subjects with confirmed CR, PR, and SD assessed by investigator and central reviewer based on RECIST v1.1
Measured: Up to 3 years
Duration of Response
Time from the date of first objective response (CR or PR) after investigational drug administration to the first documented disease progression (PD) or death from any cause, with documentation of disease progression status and cause of death, assessed by investigator and central reviewer based on RECIST v1.1
Measured: Up to 3 years
Progression free survival rate
the proportion of patients without documented progression and alive 6 months after the first dose of study drug
Measured: 6 month
Cmax
Maximum plasma concentration
Measured: 3 weeks
Area under concentration-time curve
Area under the concentration-time curve during steady state
Measured: 15 weeks
Adverse event
Incidence and severity of AE determined according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version [v] 5.0
Measured: time from the date of the first dose of study drug until 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start10 Jan 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- STCube, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306624
- Sponsor's protocol ID
- STCUBE-004
- Status last verified
- Jul 2026
- First submitted
- 14 Dec 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07306624
- Acronym / sponsor ID
- STCUBE-004
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- BTN1A1, nsclc, immune check point inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- STCube, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nelmastobart 800mg+Docetaxel 75mg/m2 | Experimental | Drug: Nelmastobart and DocetaxelNelmastobart 800mg+Docetaxel 75mg/m2 fixed |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nelmastobart and DocetaxelNelmastobart 800mg and Docetaxel 75mg/m2 | Drug | Nelmastobart 800mg+Docetaxel 75mg/m2 |
Primary outcome
Progression free survival by central reviewer
Time frame: up to 3 years
Time from first dose until the date of objective disease progression or death assessed by central reviewer
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nelmastobart and Docetaxel in people with Non Small Cell Lung Cancer, run by STCube, Inc. at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heeyeon Jung (82-2-551-3370, junghy@stcube.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival by central reviewer (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.