SCTB41 Combined With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer (NCT07662395) | Clinical Trial Compass
RecruitingPhase 2/3
SCTB41 Combined With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer
China410 participantsStarted 2026-05-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Availability of tumor tissue samples for PD-L1 testing.
. No prior systemic anticancer therapy for the study disease.
Exclusion criteria
. 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.