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Non-Small Cell Lung Carcinoma (NSCLC)Phase 3NCT07362459

A Study to Evaluate the Safety and Tolerability of SCTB14 as First-Line Therapy in Non-Small Cell Lung Cancer.

A Phase 3 study testing SCTB14 and Pembrolizumab in people with Non-Small Cell Lung Carcinoma (NSCLC), run by Sinocelltech Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This Phase III, randomized, double-blind study compares the efficacy and safety of SCTB14 versus pembrolizumab as first-line treatment in patients with driver gene-negative, TPS ≥10% locally advanced or metastatic non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Carcinoma (NSCLC)
What is being tested?
SCTB14 and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 participants
Where
1 siteChina
Study dates
30 Dec 2025to Sep 2029
Phase
Phase 3
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 written informed consent form prior to screening.
  • Age ≥ 18 years, both male and female.
  • ECOG Performance Status score of 0 to 1.
  • An expected survival of ≥ 3 months.
  • Histologically or cytologically confirmed, unresectable locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) that is not amenable to curative surgery or radical concurrent/sequential chemoradiotherapy.
  • For subjects with non-squamous cell carcinoma, as well as non-smoking subjects with squamous cell carcinoma containing mixed adenocarcinoma components, confirmation of the absence of EGFR sensitizing mutations or ALK gene rearrangements from tumor tissue is required prior to enrollment.
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  • Subjects must provide a histology sample suitable for PD-L1 testing, with a Tumor Proportion Score (TPS) ≥ 10%.
  • No prior systemic anti-tumor therapy for the studied disease.
  • At least one measurable non-CNS lesion according to RECIST v1.1 criteria.
  • Adequate function of major organs.

Who cannot join

  • Known actionable driver gene mutations such as ROS1 fusion, BRAF V600E mutation, NTRK fusion, MET exon 14 skipping mutation, and RET fusion mutation.
  • Received non-specific immunomodulatory therapy or immunosuppressive drugs within 2 weeks before the first dose; received traditional Chinese medicine with antineoplastic indications within 1 week before the first dose.
  • Prior thoracic radiotherapy; or local anti-tumor therapy within 2 weeks before first dosing.
  • Prior treatment with antitumor immunotherapy, antiangiogenic therapy, or other small molecule tyrosine kinase inhibitor (TKI)-based antitumor drugs.
  • subjects with metastasis or compression involving the brainstem, meninges, or spinal cord, or those with active CNS metastases or multiple brain metastases.
  • Imaging demonstrates tumor invasion of major blood vessels, significant necrosis or cavitation within the primary tumor lesions, or the presence of lymphangitic carcinomatosis.
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  • Imaging demonstrates tumor invasion or compression of adjacent vital organs or carries a risk of developing an esophagotracheal fistula or esophagopleural fistula.
  • History of hypertensive crisis or hypertensive encephalopathy, or the presence of uncontrolled hypertension despite medication, or poorly controlled diabetes despite pharmacotherapy.
  • A history of arterial thrombosis, deep vein thrombosis, cerebral infarction, transient ischemic attack, or significant vascular disease within 6 months prior to enrollment.
  • A history of myocardial infarction, unstable angina, cardiac insufficiency with New York Heart Association (NYHA) class ≥ III, or severe arrhythmia uncontrolled by medication within 6 months prior to enrollment.
  • The presence of any active autoimmune disease or a history of autoimmune disease with an anticipated recurrence.
  • A history of esophageal/gastric varices, severe ulcer, abdominal fistula, intra-abdominal abscess, gastrointestinal perforation and/or fistula, acute gastrointestinal bleeding, intestinal obstruction, or extensive intestinal resection within 6 months prior to the first dose.
  • A history of bleeding tendency, high bleeding risk, or coagulation dysfunction,.
  • The presence of other malignant tumors.
  • Toxicities from prior neoadjuvant/adjuvant therapy, surgery, radiotherapy, or other previous antitumor treatments have not recovered to Grade 0-1.
  • Receipt of a live or attenuated vaccine within 4 weeks prior to the first dose, or a plan to receive a live or attenuated vaccine during the study period; however, the use of inactivated vaccines is permitted.
  • Presence of any of the following infectious conditions: a) severe infection within 4 weeks prior to the first dose; b) active infection within 2 weeks prior to enrollment; c) active tuberculosis; d) positive HIV antibody; e) active hepatitis B or C; f) known active syphilis.
  • Major surgery planned or anticipated during the study period, or unhealed tissue present before enrollment..
  • Presence of symptomatic or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage.
  • A history of non-infectious pneumonia requiring treatment or the presence of interstitial lung disease
  • A history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Known hypersensitivity to any component of the investigational drug or a documented history of severe hypersensitivity reactions to any other monoclonal antibody.
  • Current participation in another clinical trial, with the exception of observational (non-interventional) studies or the follow-up phase of an interventional trial.
  • Pregnancy or lactation in female subjects.
  • A known history of alcohol or drug addiction, psychiatric disorders, or drug abuse in the subject.
  • Tumor-induced conditions or symptoms associated with a high medical risk.
  • Any other condition deemed by the investigator to be 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, 1 recruiting

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

    Yuehua Su, 86-15652740762, yuehua_su@sinocelltech.com

    Recruiting

Other trials in China

About this study

Official title: A Phase III, Randomized, Double-blind, Multicenter Clinical Study to Evaluate the Efficacy and Safety of SCTB14 Versus Pembrolizumab as First-Line Therapy in Patients With Driver Gene-Negative, TPS ≥10% Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This Phase III, randomized, double-blind study compares the efficacy and safety of SCTB14 versus pembrolizumab as first-line treatment in patients with driver gene-negative, TPS ≥10% locally advanced or metastatic non-small cell lung cancer (NSCLC). The primary objective is to assess superiority of SCTB14 over pembrolizumab in prolonging progression-free survival. Safety will be closely monitored.

Being tested
SCTB14, Pembrolizumab
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.

  • SCTB14Drug

    SCTB14 is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle.

  • PembrolizumabDrug

    Pembrolizumab is administered at a fixed dose of 200 mg by intravenous infusion on Day 1 of each 3-week cycle.

Study groups in NCT07362459
Study groupRoleWhat they receive
SCTB14Experimentalintravenous infusion on Day 1 of each 3-week cycle
Receives: Drug: SCTB14
PembrolizumabActive comparator200mg, intravenous infusion on Day 1 of each 3-week cycle
Receives: Drug: Pembrolizumab

What is being measured

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

  1. Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review

    Time from randomization to first documented progression or death (whichever occurs first).

    Measured: Up to approximately 1.5 years

Secondary outcomes (14)

  1. overall survival

    The time from the date of randomization to the date of death from any cause.

    Measured: Up to approximately 5 years

  2. Progression-Free Survival (PFS) as Assessed by Investigator

    Time from randomization to first documented progression or death (whichever occurs first).

    Measured: Up to approximately 1.5 years

  3. Confirmed Objective Response Rate (ORR) Assessed by Blinded Independent Central Review

    The proportion of subjects with a best overall confirmed response of Complete Response (CR) or Partial Response (PR)

    Measured: Up to approximately 1.5 years

  4. Disease Control Rate (DCR) Assessed by Blinded Independent Central Review

    The proportion of patients with a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD).

    Measured: Up to approximately 1.5 years

  5. Duration of Response （DOR）Assessed by Blinded Independent Central Review

    The time from the first documented objective response (Complete Response [CR] or Partial Response [PR]) to the first documented disease progression or death from any cause, whichever occurs first.

    Measured: Up to approximately 1.5 years

  6. Time to Response (TTR)

    Time from the date of randomization to the first documented objective response (Complete Response [CR] or Partial Response [PR]

    Measured: Up to approximately 1.5 years

  7. Treatment-Emergent Adverse Event（TEAE）

    Any adverse event that occurs or worsens in severity after the initiation of study drug administration

    Measured: The first dose of study drug until 30 days (±7 days) after the last dose

  8. Serious adverse events (SAEs)

    An adverse medical event occurring after a subject receives the investigational drug that results in any of the following outcomes: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

    Measured: From the first dose of study druguntil 60 days after the last dose.

  9. immune-related adverse events (irAEs)

    All grades of adverse drug reactions (ADRs) that occur after a subject receives the investigational drug and are assessed as having a causal relationship to an immune-mediated mechanism.

    Measured: From the first dose of study druguntil 60 days after the last dose

  10. PD-L1 expression

    The correlationship between PD-L1 expression and anti-tumor activity.

    Measured: Up to approximately 1.5 years.

  11. Quality of Life Questionnaire

    Change in Health-Related Quality of Life EORTC QLQ-C30

    Measured: Up to approximately 1.5 years.

  12. Quality of Life Questionnaire

    Change in Health-Related Quality of Life QLQ-LC13

    Measured: Up to approximately 1.5 years

  13. Anti-drug antibodies (ADA)

    Number and percentage of subjects with anti-drug antibodies (ADA) to SCTB14

    Measured: Up to approximately 1.5 years

  14. Pharmacokinetic (PK)

    Serum concentration of SCTB14 at different time points

    Measured: Up to approximately 1.5 years.

Timeline

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

  1. First posted23 Jan 2026
  2. Study start30 Dec 2025
  3. Primary completionJul 2027 (estimated)
  4. Study completionSep 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
246 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07362459
Sponsor's protocol ID
SCTB14-A301
Status last verified
Jan 2026
First submitted
9 Jan 2026
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SCTB14 and Pembrolizumab in people with Non-Small Cell Lung Carcinoma (NSCLC), 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 10 inclusion and 27 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 23 Jan 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (time frame: Up to approximately 1.5 years). 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 NCT07362459.

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 23 Jan 2026.

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