Neoadjuvant Chemotherapy and Tilelizumab in Stage III（cTNM-IIIA.IIIB）Non-small-cell Lung Cancer

NCT04865705 | Unknown Phase 2

• 1 other identifier: BGB-A317-2020
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, one-arm, phase II study aimed at evaluating tislelizumab combined with platinum-containing dual-drug chemotherapy as a neoadjuvant treatment, supplemented with tislelizumab after surgery in patients with stage III non-small cell lung cancer.

Conditions

Stage III; Non-small Cell Lung Cancer

Keywords

stage III; driver gene negative; Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of radical resection (R0)

  In the intention-to-treat (ITT) analysis set, the rate of radical resection (R0) is evaluated by the investigator, which is the number of people who can undergo R0 resection after the evaluation criteria established by the MDT team divided by the total number of enrolled groups

  2 weeks after neoadvant

Secondary Outcomes (1)

• PFS

  up to 24-month

Other Outcomes (2)

• Biomarker level of PD-L1

  2 weeks after surgery

• Biomarker count of CD8+T cell

  2 weeks after surgery

Study Arms (1)

Tilelizumab+Albumin Paclitaxel + Carboplatin/Cisplatin

EXPERIMENTAL

Tilelizumab 200mg d1 Albumin Paclitaxel 260mg/m2 d1 Carboplatin/Cisplatin 75mg/m2/AUC5 d1IV,Q3W \*2cycles

Drug: tislelizumab

Interventions

tislelizumab DRUG

Tilelizumab 200mg d1 Q3W Albumin Paclitaxel 260mg/m2 d1 Carboplatin/Cisplatin 75mg/m2/AUC5 d1 every 3 weeks

Also known as: Albumin Paclitaxel, Carboplatin/Cisplatin

Tilelizumab+Albumin Paclitaxel + Carboplatin/Cisplatin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Untreated and histologically confirmed stage III (T2N2, T3-4N1-2) NSCLC (as defined by the American Joint Committee on Cancer 8th Edition)
• If the driver gene negative for EGFR sensitive mutations and ALK and ROS1 gene fusion mutations has not been detected before, test specimen tissue/blood
• Tumor assessment scan using (CT) and (PET-CT) or magnetic resonance (MRI)
• The date of signing the informed consent is ≥18 years old and ≤65 years old
• Eastern Cooperative Oncology Group (ECOG) physical status is 0 or 1
• Have measurable diseases assessed by the investigator according to RECIST Version 1.1
• After neoadjuvant treatment, the MDT team and the chief surgeon comprehensively assessed and confirmed that they meet the requirements for radical resection
• After neoadjuvant therapy, evaluate once every 2 cycles. For PD, discontinue tislelizumab and receive simultaneous radiotherapy. PR/SD patients will discuss MDT and adopt surgical treatment;
• Good cardiopulmonary function, able to tolerate surgery
• Eligible to receive platinum-containing dual-drug chemotherapy
• Can provide representative pre-treatment tumor tissue samples/peripheral blood samples for biomarker analysis.

You may not qualify if:

• Have received any treatment for the current lung cancer, including chemotherapy or radiotherapy 1.Patients with positive driver genes are known to carry EGFR mutations or ALK, ROS1 gene translocations
• After neoadjuvant treatment, pneumonectomy is still required at the last evaluation
• Suffered from any disease requiring systemic treatment with corticosteroids (daily dose of prednisone or equivalent drugs\> 10 mg) or other immunosuppressive drugs in the 14 days before enrollment
• Adrenaline replacement steroids (daily doses\> 10 mg of prednisone or equivalent) are allowed for topical, ocular, intra-articular, intranasal or inhaled corticosteroids, and minimum systemic absorption is required, and they are prescribed Corticosteroids are short-term (≤7 days) medication, or used to treat non-autoimmune diseases
• A history of active autoimmune disease or autoimmune disease that may recur.
• Allow entry for patients with: well-controlled type I diabetes, hypothyroidism that requires only hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss), or predicted without external causes A disease that does not recur. The chest CT scan performed during the screening period has evidence of idiopathic pulmonary fibrosis, organic pneumonia (such as bronchiolitis obliterans), or a history of non-infectious pneumonia
• Severe infections occurred within 4 weeks before enrollment, including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia
• Severe chronic or active infections (including tuberculosis infection, etc.) that require systemic (oral or intravenous) antibiotic treatment within 14 days before enrollment
• A history of interstitial lung disease, non-infectious pneumonia or poorly controlled diseases, including pulmonary fibrosis, acute lung disease, etc.
• Untreated patients with chronic hepatitis B or HBV carriers with hepatitis B virus (HBV) DNA ≥ 500 IU/mL, or patients with active hepatitis C virus (HCV) should be excluded. Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B carriers (HBV DNA \<500 IU/mL), and cured hepatitis C patients can be included in the group.
• If any major surgery requiring general anesthesia has been performed ≤28 days before randomization.
• Previous allogeneic stem cell transplantation or organ transplantation. -

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

tislelizumab; Carboplatin; Cisplatin

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)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• yongseng wang

  West China Hospital

  PRINCIPAL INVESTIGATOR

• qinghua zhou

  West China Hospital

  PRINCIPAL INVESTIGATOR

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 Surgical Oncology and Molecular Biology

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: April 29, 2021
• Study Start: November 10, 2020
• Primary Completion: December 10, 2021
• Study Completion: June 10, 2022
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

CN (1)