SCTB41 plus chemotherapy vs tislelizumab plus chemotherapy as first-line treatment for advanced NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase II/III, multicenter study in driver-negative locally advanced or metastatic NSCLC. It starts with an open-label safety run-in of SCTB41 plus chemotherapy to assess safety and early signals of activity, then moves to a randomized, double-blind comparison of SCTB41 plus chemotherapy versus tislelizumab plus chemotherapy. The primary outcome is progression-free survival, measured by blinded independent central review using RECIST 1.1. Eligible patients are adults with good performance status and adequate organ function, not candidates for definitive chemoradiation, and without sensitizing EGFR mutations or ALK rearrangements.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntary written informed consent (ICF) signed prior to screening.
2. Age ≥18 years, male or female.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Expected survival ≥3 months.
5. 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).
6. 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.
7. Availability of tumor tissue samples for PD-L1 testing.
8. No prior systemic anticancer therapy for the study disease.
9. At least one measurable lesion (excluding brain lesions) per RECIST v1.1. 10 Adequate organ function.

Exclusion Criteria:

1. Known ROS1 fusion-positive, BRAF V600E mutation, or other driver mutations for which guideline-recommended first-line targeted therapies are available.
2. Prior thoracic radiotherapy.
3. Symptomatic central nervous system metastases.
4. 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.
5. History of hypertensive crisis or hypertensive encephalopathy, or uncontrolled hypertension despite medication.
6. Active autoimmune disease or a history of autoimmune disease with a risk of recurrence.
7. Bleeding tendency, high bleeding risk, or coagulation disorders.
8. Other malignancies.
9. Active serious infection prior to first dose, including active infection, active tuberculosis, HIV positivity, active hepatitis B or C, or known active syphilis.
10. Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
11. History of non-infectious pneumonia requiring systemic corticosteroid therapy or current interstitial lung disease.
12. Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
13. Known allergy to any component of the investigational drug(s), or history of severe hypersensitivity reaction to any monoclonal antibody.
14. Participation in another clinical trial, except for follow-up in observational (non-interventional) studies or follow-up phases of interventional studies.
15. Pregnant or breastfeeding women.
16. Known alcohol or drug abuse, psychiatric disorders, or history of illicit drug use.
17. Any other condition deemed unsuitable for enrollment by the investigator.

Where it's running

• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: yanyan yang, medical monitor
• Email: yanyan_yang@sinocelltech.com
• Phone: +8618353576376

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.