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NSCLC (Advanced Non-small Cell Lung Cancer)Phase 2NCT07609251

A Clinical Study of SCTB41 Combined With Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer（Phase II Study Ongoing）

A Phase 2 study testing SCTB41 and docetaxel in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Sinocelltech Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate the safety and efficacy of SCTB41 combined with docetaxel in patients with previously treated non-small cell lung cancer. The Phase II part of this study is an open-label, multicenter clinical trial. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SCTB41 and docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
May 2026to Jul 2029
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily sign the informed consent form (ICF);
  • ECOG 0-1;
  • Survival duration more than 3 months;
  • Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) that is not amenable to complete surgical resection and cannot receive curative concurrent/sequential chemoradiotherapy;
  • Without AGA: Have experienced disease progression during or after prior treatment with PD-(L)1 inhibitors and chemotherapy.With AGA: Must have received adequate targeted therapy; EGFR-positive patients must have received prior treatment with PD-(L)1/VEGF bispecific antibody and/or TROP-2 ADC;
  • At least one measurable non-brain lesion according to RECIST v1.1;
  • Adequate major organ function.

Who cannot join

  • Histologically or cytologically confirmed presence of small cell carcinoma components;
  • Prior treatment with docetaxel;
  • Symptomatic central nervous system (CNS) metastases;
  • Received the last dose of prior systemic anti-tumor therapy within 4 weeks before the first dose of study drug;
  • Imaging findings at screening show tumor invasion into major blood vessels or surrounding vital organs, or the presence of a risk of esophagotracheal or esophagopleural fistula, which the investigator assesses as unsuitable for enrollment;
  • History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension despite medical therapy;
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  • Presence of any active autoimmune disease or history of autoimmune disease with anticipated risk of relapse;
  • Bleeding tendency, high risk of bleeding, or coagulation disorders;
  • Diagnosis of another malignancy;
  • Severe infection, active infection, active tuberculosis, positive HIV antibody, active hepatitis B or hepatitis C, or known active syphilis prior to the first dose;
  • Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
  • History of non-infectious pneumonitis that required systemic corticosteroid therapy, or current presence of interstitial lung disease;
  • Prior history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • Known hypersensitivity to any component of the study drug; known hypersensitivity to taxanes; or history of severe hypersensitivity reaction to any other monoclonal antibody;
  • Pregnant or breastfeeding women;
  • Any other condition that the investigator considers inappropriate for enrollment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, Hubei, 430030

    Zhe Huang, +86-010-58628288, zhe_huang@sinocelltech.com

Other trials in China

About this study

Official title: A Phase II/III Study of SCTB41 Plus Docetaxel vs Placebo Plus Docetaxel in Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This study aims to evaluate the safety and efficacy of SCTB41 combined with docetaxel in patients with previously treated non-small cell lung cancer. The Phase II part of this study is an open-label, multicenter clinical trial.

Being tested
SCTB41, docetaxel
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.

  • SCTB41Drug

    SCTB41 is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle

  • docetaxelDrug

    docetaxel is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle

Study groups in NCT07609251
Study groupRoleWhat they receive
SCTB41+docetaxelExperimentalNot described
Receives: Drug: SCTB41; Drug: docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of adverse events (AEs)

    To investigate the safety characteristics.

    Measured: 24 months

Secondary outcomes (4)

  1. Objective response rate (ORR)

    The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.

    Measured: Up to 2 years

  2. Disease control rate (DCR)

    The DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST Version 1.1.

    Measured: Up to 2 years

  3. Progression-free survival (PFS)

    The PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first.

    Measured: Up to 2 years

  4. Overall survival (OS)

    Overall survival is defined as the time from the start of treatment until death due to any cause.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2026
  2. Study startMay 2026 (estimated)
  3. Primary completionOct 2028 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

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
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07609251
Sponsor's protocol ID
SCTB41-A302
Status last verified
May 2026
First submitted
14 May 2026
Last updated
27 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SCTB41 and docetaxel in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by Sinocelltech Ltd. at 1 site in China.

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 7 inclusion and 16 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: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of adverse events (AEs) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07609251.

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 27 May 2026.

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