Loading clinical trials...

NOT_YET_RECRUITINGPHASE2

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

Prospective Phase II Trial of Neoajuvant Tislelizumab Combined with Chemotherapy for Initially Unresectable Stage IIIA/N2 Non-small Cell Lung Cancer

NCT06614231•Sun Yat-sen University

View on ClinicalTrials.gov

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.

Detailed Description

This study is a prospective, single-arm, single-center phase II clinical trial to investigate the efficacy and safety of neoadjuvant treatment with tirilizumab in combination with chemotherapy in patients with initially inoperable stage III/N2 non-small cell lung cancer. Patients with stage III/N2 non-small cell lung cancer that is initially inoperable and clearly staged and meets the enrollment criteria will receive 3 cycles of tirilizumab (200 mg) in combination with chemotherapy and will be evaluated by imaging of their tumor status. After MDT evaluation patients will either undergo surgery or be withdrawn from the study and receive a combination of radiotherapy and chemotherapy, with postoperative adjuvant therapy at the discretion of the physician. The primary endpoint of this study is the surgical conversion rate; secondary endpoints include MPR, pCR, safety, and EFS.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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
•2. All patients received baseline PET/CT (or neck, upper thoracic and abdominal CT+ cranial MR) for clinical staging
•3. Cytology/histology (mediastinoscopy or EBUS, etc.) confirmed N2 non-small cell lung cancer
•4. 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
•5. ECOG (Performance status, PS) score 0-1
•6. 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
+7 more criteria

Exclusion Criteria

•1. The patient presents with a confirmed or suspected autoimmune disorder.
•* Note: Patients with vitiligo, type I diabetes mellitus, or Hashimoto\&#39;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
•2. 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
•3. Patients with grade 3 or 4 interstitial lung disease
•4. Have other malignant tumors and need anti-tumor therapy
•5. 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
•6. The investigator believes that the patient is medically, psychologically, or physically incapable of completing this study or of understanding the patient handbook information
•7. 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
•8. Presence of active Hepatitis B or C
+3 more criteria

Key Dates

Start Date

September 20, 2024

Primary Completion Date

September 8, 2028

Completion Date

September 8, 2028

Last Updated

September 26, 2024

Enrollment

ESTIMATED participants

Conditions

NSCLC, Stage IIIANSCLC (non-small Cell Lung Cancer)

Interventions

Tislelizumab Combined With Chemotherapy

DRUG

Contacts

Xue Hou, MD

CONTACT

+86-13570569436 houxue@sysucc.org.cn

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

NCT04585750

Advanced Solid TumorAdvanced Malignant Neoplasm+28 more

View study

RECRUITINGPHASE1

A Phase 1/1b Study of IAM1363 in HER2 Cancers

NCT06253871

HER2 Mutation-Related TumorsHER2+11 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 26, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

A Phase 1/1b Study of IAM1363 in HER2 Cancers

A Study of GV20-0251 in Advanced or Refractory Solid Tumors

Cryoablation Combined With Tislelizumab and Chemotherapy as Neoadjuvant and Adjuvant Therapy in Resectable Stage II-IIIB NSCLC

Artificial Intelligence-based Model for the Prediction of Occult Lymph Node Metastasis and Improvement of Clinical Decision-making in Non-small Cell Lung Cancer

Cognitive Screening in Lung Cancer Patients