SCTB41 Combined With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer

NCT07662395 | Recruiting Phase 2 DMC

• 1 other identifier: SCTB41-A303
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter Phase II/III study evaluating the efficacy and safety of SCTB41 combined with chemotherapy versus tislelizumab combined with chemotherapy as first-line treatment in patients with driver-negative locally advanced or metastatic non-small cell lung cancer (NSCLC). The Phase II portion is an open-label safety run-in study enrolling approximately 30-60 patients to evaluate the safety and tolerability of SCTB41 plus chemotherapy. Following confirmation of acceptable safety and preliminary efficacy, the study will proceed to the Phase III portion. The Phase III portion is a randomized, double-blind, active-controlled study enrolling approximately 350 patients. Eligible participants will be randomized in a 1:1 ratio to receive SCTB41 plus chemotherapy or tislelizumab plus chemotherapy. The primary objective is to compare progression-free survival assessed by blinded independent central review according to RECIST version 1.1.

Conditions

Double Blind

Keywords

Advanced Non-Small Cell Lung Cancer; Non-Small Cell Lung Cancer; SCTB41

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the blinded IRRC or death due to any cause (whichever occurs first).

  Up to approximately 24 months.

Study Arms (2)

SCTB41 + Chemotherapy

EXPERIMENTAL

SCTB41 will be administered at a selected dose intravenously (IV) every three weeks (Q3W). Chemotherapy regimen will be selected by the investigator based on histological subtype: squamous NSCLC receives carboplatin + paclitaxel or nab-paclitaxel; non-squamous NSCLC receives pemetrexed + cisplatin or carboplatin. Combination therapy will be administered for 4 cycles , followed by maintenance therapy according to the protocol.

Drug: SCTB41; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed

Tislelizumab + Chemotherapy

ACTIVE COMPARATOR

Tislelizumab will be administered at a dose of 200 mg intravenously (IV) every three weeks (Q3W). Chemotherapy regimen will be selected by the investigator based on histological subtype: squamous NSCLC receives carboplatin + paclitaxel or nab-paclitaxel; non-squamous NSCLC receives pemetrexed + cisplatin or carboplatin. Combination therapy will be administered for 4 cycles, followed by maintenance therapy according to the protocol.

Drug: Tislelizumab; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed

Interventions

SCTB41 DRUG

IV infusion,Specified dose on specified days.

SCTB41 + Chemotherapy

Tislelizumab DRUG

IV infusion,Specified dose on specified days.

Tislelizumab + Chemotherapy

Paclitaxel DRUG

175 mg/m², IV infusion, Q3W, for 4 cycles.

SCTB41 + Chemotherapy; Tislelizumab + Chemotherapy

Nab-paclitaxel DRUG

100 mg/m², IV infusion, on Days 1, 8, 15 of each 3-week cycle, for 4 cycles

SCTB41 + Chemotherapy; Tislelizumab + Chemotherapy

Carboplatin DRUG

AUC 5, IV infusion, Q3W, for 4 cycles.

SCTB41 + Chemotherapy; Tislelizumab + Chemotherapy

Cisplatin DRUG

75 mg/m², IV infusion, Q3W, for 4 cycles.

SCTB41 + Chemotherapy; Tislelizumab + Chemotherapy

Pemetrexed DRUG

500 mg/m², IV infusion, Q3W, for 4 cycles .

SCTB41 + Chemotherapy; Tislelizumab + Chemotherapy

Eligibility Criteria

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

You may qualify if:

• Voluntary written informed consent (ICF) signed prior to screening.
• Age ≥18 years, male or female.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Expected survival ≥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 is not suitable for definitive concurrent or sequential chemoradiotherapy, according to the 9th edition of the TNM staging system by the Union for International Cancer Control (UICC) and the American Joint Committee on Cancer (AJCC).
• For subjects with adenocarcinoma, non-smokers, or squamous cell carcinoma with mixed adenocarcinoma components, absence of sensitizing EGFR mutations (e.g., exon 19 deletion, exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I) or ALK gene rearrangements must be confirmed by tumor tissue, cytology, or blood samples prior to enrollment.
• Availability of tumor tissue samples for PD-L1 testing.
• No prior systemic anticancer therapy for the study disease.
• At least one measurable lesion (excluding brain lesions) per RECIST v1.1. 10 Adequate organ function.

You may not qualify if:

• Known ROS1 fusion-positive, BRAF V600E mutation, or other driver mutations for which guideline-recommended first-line targeted therapies are available.
• Prior thoracic radiotherapy.
• Symptomatic central nervous system metastases.
• Imaging evidence during screening showing tumor invasion of major blood vessels, invasion of critical surrounding organs, or risk of tracheoesophageal fistula or esophagopleural fistula as assessed by the investigator.
• History of hypertensive crisis or hypertensive encephalopathy, or uncontrolled hypertension despite medication.
• Active autoimmune disease or a history of autoimmune disease with a risk of recurrence.
• Bleeding tendency, high bleeding risk, or coagulation disorders.
• Other malignancies.
• Active serious infection prior to first dose, including active infection, active tuberculosis, HIV positivity, active hepatitis B or C, or known active syphilis.
• Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• History of non-infectious pneumonia requiring systemic corticosteroid therapy or current interstitial lung disease.
• Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Known allergy to any component of the investigational drug(s), or history of severe hypersensitivity reaction to any monoclonal antibody.
• Participation in another clinical trial, except for follow-up in observational (non-interventional) studies or follow-up phases of interventional studies.
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

tislelizumab; Paclitaxel; 130-nm albumin-bound paclitaxel; Carboplatin; Cisplatin; Pemetrexed

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Central Study Contacts

yanyan yang, medical monitor

CONTACT

+8618353576376; yanyan_yang@sinocelltech.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are randomized in a 1:1 ratio using a stratified block design, with stratification factors of pathological type (squamous vs. non-squamous), PD-L1 expression (TPS \<1%, 1-49%, ≥50%), and tumor clinical stage (Stage III vs. Stage IV).

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 23, 2026
• Study Start: May 9, 2026
• Primary Completion (Estimated): January 24, 2030
• Study Completion (Estimated): January 24, 2030
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)