Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05468242

Study of Tislelizumab for Locally Advanced Non-Small Cell Lung Cancer Following Neoadjuvant Chemotherapy Plus Tislelizumab ± Bevacizumab and Definitive Concurrent Chemoradiation Therapy

Led by Sun Yat-sen University · Updated on 2024-10-30

116

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The phase II Study is to explore the efficacy and safety of Tislelizumab as consolidation therapy in patients with locally advanced non-small cell lung cancer who have not progressed following neoadjuvant chemotherapy plus Tislelizumab ± Bevacizumab and definitive concurrent chemoradiation therapy.

CONDITIONS

Official Title

Study of Tislelizumab for Locally Advanced Non-Small Cell Lung Cancer Following Neoadjuvant Chemotherapy Plus Tislelizumab ± Bevacizumab and Definitive Concurrent Chemoradiation Therapy

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed, written, and dated informed consent before study procedures
  • Male or female aged 18 to 75 years
  • Histologically or cytologically confirmed locally advanced (Stage III) non-small cell lung cancer
  • No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy
  • Life expectancy of at least 12 weeks
  • World Health Organization (WHO) Performance Status of 0 or 1
  • Post-menopausal status or negative pregnancy test within 14 days before study drug use for pre-menopausal females
  • Women must not be breastfeeding
  • Forced expiratory volume in 1 second (FEV1) of 800 ml or more
  • Absolute neutrophil count greater than 1.5 x 10^9/L (1500 per mm3)
  • Platelet count greater than 100 x 10^9/L (100,000 per mm3)
  • Hemoglobin 9.0 g/dL or higher
  • Serum creatinine clearance greater than 50 mL/min by Cockcroft-Gault formula
  • Serum bilirubin at or below 1.5 times the upper limit of normal (ULN)
  • Aspartate transaminase (AST) and alanine transaminase (ALT) at or below 2.5 times ULN
Not Eligible

You will not qualify if you...

  • Enrollment in another clinical study unless observational and non-interventional
  • Mixed small cell and non-small cell lung cancer histology
  • Use of immunosuppressive medication within 28 days before first Tislelizumab dose except certain corticosteroids
  • Prior exposure to anti-PD-1 or anti-PD-L1 antibodies
  • Major surgery within 4 weeks before study entry preventing Tislelizumab administration
  • Active or past autoimmune disease within 2 years
  • Active or prior inflammatory bowel disease such as Crohn's disease or ulcerative colitis
  • History of primary immunodeficiency or organ transplant requiring immunosuppression
  • Tumor invading major blood vessels like pulmonary artery or superior vena cava
  • Bleeding or coagulation disorders
  • Serious heart or cardiovascular conditions within 6 months
  • Uncontrolled hypertension (systolic >150 mmHg or diastolic >100 mmHg)
  • Recent major or minor surgery or biopsy within specified timeframes
  • Significant urine protein abnormalities
  • Prolonged QT interval on ECG
  • Uncontrolled illness including infections, psychiatric illness, or social situations limiting compliance
  • Known tuberculosis
  • Live attenuated vaccine within 30 days before or after study entry
  • Another primary cancer within 5 years except certain skin or cervical cancers
  • Pregnant or breastfeeding women or patients not using effective birth control
  • Any condition interfering with study evaluation or safety
  • Disease progression or poor performance status before chemoradiation
  • Inadequate organ or marrow function as defined by lab values
  • Unresolved or severe toxicities from prior therapies
  • Grade 2 or higher pneumonitis from prior chemoradiation
  • Prior severe immune-related adverse events from immunotherapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Sun Yat-sen University

Guangzhou, China, 510060

Actively Recruiting

Loading map...

Research Team

B

Bo Qiu, MD

CONTACT

D

DaQuan Wang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here