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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Small Cell Lung Carcinoma (NSCLC)
• Intervention / Treatment: Drug: SCTB14; Drug: Pembrolizumab

• Study Type: Interventional
• Enrollment (Estimated): 246
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Yuehua Su; Phone Number: 86-15652740762; Email: yuehua_su@sinocelltech.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Voluntarily sign the written informed consent form prior to screening.
2. Age ≥ 18 years, both male and female.
3. ECOG Performance Status score of 0 to 1.
4. An expected survival of ≥ 3 months.
5. 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.
6. 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.
7. Subjects must provide a histology sample suitable for PD-L1 testing, with a Tumor Proportion Score (TPS) ≥ 10%.
8. No prior systemic anti-tumor therapy for the studied disease.
9. At least one measurable non-CNS lesion according to RECIST v1.1 criteria.
10. Adequate function of major organs.

Exclusion Criteria:

1. Known actionable driver gene mutations such as ROS1 fusion, BRAF V600E mutation, NTRK fusion, MET exon 14 skipping mutation, and RET fusion mutation.
2. 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.
3. Prior thoracic radiotherapy; or local anti-tumor therapy within 2 weeks before first dosing.
4. Prior treatment with antitumor immunotherapy, antiangiogenic therapy, or other small molecule tyrosine kinase inhibitor (TKI)-based antitumor drugs.
5. subjects with metastasis or compression involving the brainstem, meninges, or spinal cord, or those with active CNS metastases or multiple brain metastases.
6. Imaging demonstrates tumor invasion of major blood vessels, significant necrosis or cavitation within the primary tumor lesions, or the presence of lymphangitic carcinomatosis.
7. Imaging demonstrates tumor invasion or compression of adjacent vital organs or carries a risk of developing an esophagotracheal fistula or esophagopleural fistula.
8. History of hypertensive crisis or hypertensive encephalopathy, or the presence of uncontrolled hypertension despite medication, or poorly controlled diabetes despite pharmacotherapy.
9. A history of arterial thrombosis, deep vein thrombosis, cerebral infarction, transient ischemic attack, or significant vascular disease within 6 months prior to enrollment.
10. 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.
11. The presence of any active autoimmune disease or a history of autoimmune disease with an anticipated recurrence.
12. 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.
13. A history of bleeding tendency, high bleeding risk, or coagulation dysfunction,.
14. The presence of other malignant tumors.
15. Toxicities from prior neoadjuvant/adjuvant therapy, surgery, radiotherapy, or other previous antitumor treatments have not recovered to Grade 0-1.
16. 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.
17. 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.
18. Major surgery planned or anticipated during the study period, or unhealed tissue present before enrollment..
19. Presence of symptomatic or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage.
20. A history of non-infectious pneumonia requiring treatment or the presence of interstitial lung disease
21. A history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
22. Known hypersensitivity to any component of the investigational drug or a documented history of severe hypersensitivity reactions to any other monoclonal antibody.
23. Current participation in another clinical trial, with the exception of observational (non-interventional) studies or the follow-up phase of an interventional trial.
24. Pregnancy or lactation in female subjects.
25. A known history of alcohol or drug addiction, psychiatric disorders, or drug abuse in the subject.
26. Tumor-induced conditions or symptoms associated with a high medical risk.
27. Any other condition deemed by the investigator to be inappropriate for enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCTB14; intravenous infusion on Day 1 of each 3-week cycle	Drug: SCTB14; SCTB14 is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle.
Active Comparator: Pembrolizumab; 200mg, intravenous infusion on Day 1 of each 3-week cycle	Drug: Pembrolizumab; Pembrolizumab is administered at a fixed dose of 200 mg by intravenous infusion on Day 1 of each 3-week cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review	Time from randomization to first documented progression or death (whichever occurs first).	Up to approximately 1.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	The time from the date of randomization to the date of death from any cause.	Up to approximately 5 years
Progression-Free Survival (PFS) as Assessed by Investigator	Time from randomization to first documented progression or death (whichever occurs first).	Up to approximately 1.5 years
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)	Up to approximately 1.5 years
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).	Up to approximately 1.5 years
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.	Up to approximately 1.5 years
Time to Response (TTR)	Time from the date of randomization to the first documented objective response (Complete Response [CR] or Partial Response [PR]	Up to approximately 1.5 years
Treatment-Emergent Adverse Event（TEAE）	Any adverse event that occurs or worsens in severity after the initiation of study drug administration	The first dose of study drug until 30 days (±7 days) after the last dose
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.	From the first dose of study druguntil 60 days after the last dose.
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.	From the first dose of study druguntil 60 days after the last dose
PD-L1 expression	The correlationship between PD-L1 expression and anti-tumor activity.	Up to approximately 1.5 years.
Quality of Life Questionnaire	Change in Health-Related Quality of Life EORTC QLQ-C30	Up to approximately 1.5 years.
Quality of Life Questionnaire	Change in Health-Related Quality of Life QLQ-LC13	Up to approximately 1.5 years
Anti-drug antibodies (ADA)	Number and percentage of subjects with anti-drug antibodies (ADA) to SCTB14	Up to approximately 1.5 years
Pharmacokinetic (PK)	Serum concentration of SCTB14 at different time points	Up to approximately 1.5 years.

Collaborators and Investigators

• Sponsor: Sinocelltech Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; pembrolizumab
• Other Study ID Numbers: SCTB14-A301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No