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

NCT07362459 | Recruiting Phase 3 DMC

• 1 other identifier: SCTB14-A301
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

Brief 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). The primary objective is to assess superiority of SCTB14 over pembrolizumab in prolonging progression-free survival. Safety will be closely monitored.

Conditions

Non-Small Cell Lung Carcinoma (NSCLC)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• overall survival

  Up to approximately 5 years

• Progression-Free Survival (PFS) as Assessed by Investigator

  Up to approximately 1.5 years

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

  Up to approximately 1.5 years

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

  Up to approximately 1.5 years

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

  Up to approximately 1.5 years

Study Arms (2)

SCTB14

EXPERIMENTAL

intravenous infusion on Day 1 of each 3-week cycle

Drug: SCTB14

Pembrolizumab

ACTIVE COMPARATOR

200mg, intravenous infusion on Day 1 of each 3-week cycle

Drug: Pembrolizumab

Interventions

SCTB14 DRUG

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

SCTB14

Pembrolizumab DRUG

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

Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 23, 2026
• Study Start: December 30, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)