Neoajuvant Tislelizumab Combined with Chemotherapy for Initially Unresectable Stage IIIA/N2 Non-small Cell Lung Cancer

NCT06614231 | Not Yet Recruiting Phase 2

• 1 other identifier: B2024-446-01
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the efficacy and safety of neoadjuvant treatment with Tislelizumab combined with chemotherapy for initially unresectable N2/III non-small cell lung cancer.

Conditions

NSCLC, Stage IIIA; NSCLC (non-small Cell Lung Cancer)

Keywords

Unresectable stage III NSCLC; Tirellizumab; Neoadjuvant treatment

Outcome Measures

Primary Outcomes (1)

• Surgical conversion rate

  After 3 cycles of Tislelizumab combined with chemotherapy, the number of patients who underwent surgical resection/number of patients enrolled

  Within 4-6 weeks (+7 days) after the third cycle of Tislelizumab combined with chemotherapy

Secondary Outcomes (2)

• Major pathologic response(MPR)

  Within one week after surgery

• Pathologic Complete response（pCR）

  Within one week after surgery

Study Arms (1)

Tislelizumab

EXPERIMENTAL

Tislelizumab 200mg Q3W

Drug: Tislelizumab Combined With Chemotherapy

Interventions

Tislelizumab Combined With Chemotherapy DRUG

Tislelizumab 200mg Q3W，Platinum-containing dual drug chemotherapy

Also known as: Platinum-containing

Tislelizumab

Eligibility Criteria

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

You may qualify if:

• Patients with initially untreated, unresectable stage III NSCLC (according to the International Association for the Study of Lung Cancer IASLC 8th Thoracic Tumor Stage) with non-small cell lung cancer
• All patients received baseline PET/CT (or neck, upper thoracic and abdominal CT+ cranial MR) for clinical staging
• Cytology/histology (mediastinoscopy or EBUS, etc.) confirmed N2 non-small cell lung cancer
• For non-squamous cell carcinoma patients, if EGFR/ALK mutation status is unknown, tissue samples should be provided for EGFR/ALK gene testing before enrollment; For patients with squamous cell carcinoma, if EGFR/ALK mutation status is unknown, testing is not required during screening
• ECOG (Performance status, PS) score 0-1
• Hematology testings meet the following requirements
• neutrophil ≥1.5\*109/L
• Platelets ≥100\*109/L
• Hemoglobin \> 9.0 g/dL
• Serum creatinine ≤1.5ULN or creatinine clearance (Ccr) ≥40mL/min
• AST/ALT≤ 3ULN
• Total bilirubin ≤1.5ULN
• FEV1≥1.2L or \> 40% of the estimated value
• INR/APTT within normal range
• The patient is over 18 years old

You may not qualify if:

• The patient presents with a confirmed or suspected autoimmune disorder.
• Note: Patients with vitiligo, type I diabetes mellitus, or Hashimoto\'s thyroiditis who are hypothyroid but require only hormone replacement therapy may be included in the study if there are no obvious signs of relapse
• Patients must have undergone systemic corticosteroid treatment (≥10mg prednisolone \[or equivalent\]/day) or received other immunosuppressive medications within 14 days prior to enrollment.
• Note: Inhaled or topical corticosteroids and adrenal hormone replacement therapy (≥10mg prednisolone \[or equivalent\]/day) can also be accepted for individuals lacking clear evidence of autoimmune disorders
• Patients with grade 3 or 4 interstitial lung disease
• Have other malignant tumors and need anti-tumor therapy
• Patients with previous malignancies (except skin malignancies other than melanoma, and in situ cancers of the following sites (bladder, stomach, colorectal, endometrial, cervix, melanoma, or breast) were not included in the study. Unless the malignancy has been in complete remission for two years or more and no additional antitumor therapy is required during the study period
• The investigator believes that the patient is medically, psychologically, or physically incapable of completing this study or of understanding the patient handbook information
• Previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA, and other drugs targeting T-cell co-stimulation or immune regulatory pathways
• Presence of active Hepatitis B or C
• HIV-positive or diagnosed with Acquired Immune Deficiency Disease (AIDS)
• Allergy to the study drug
• Women who are pregnant or breastfeeding

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy; Platinum Compounds

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)

Therapeutics; Inorganic Chemicals

Central Study Contacts

Xue Hou, MD

CONTACT

+86-13570569436; houxue@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 26, 2024
• Study Start: September 20, 2024
• Primary Completion (Estimated): September 8, 2028
• Study Completion (Estimated): September 8, 2028
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share