Neoadjuvant of Tislelizumab Combined With Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC

Phase 2

Recruiting

• Conditions: NSCLC, Stage III
• Interventions: Drug: Tislelizumab; Drug: Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC); Drug: Carboplatin

• Registration Number: NCT05611879
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

Brief Summary

The purpose of this conversion therapy study is to evaluate the safety and efficacy of neoadjuvant of Tislelizumab combined with platinum doublet for stage III unresectable locally advanced NSCLC.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-04
• Study First Submitted QC: 2022-11-04
• Study First Posted: 2022-11-10
• Study Start: 2023-03-12
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-28
• Last Update Posted: 2023-12-29
• Primary Completion: 2024-02-29
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Written informed consent provided.
• Unresectable stage III non-small cell lung cancer confirmed by histopathology or cytology.
• ECOG score is 0 or 1.
• Adequate hematological function, liver function and renal function.

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Exclusion Criteria

• Previously received systemic anti-tumor therapy for non-small cell lung cancer.
• history or current (non-infectious) pneumonia/interstitial pneumonia requiring steroid treatment.
• History or active pulmonary tuberculosis.
• Active infections that require systemic treatment.
• History or suspected autoimmune disease or immune deficiency who, in the judgment of the investigator, cannot tolerate immunotherapy.
• Untreated active Hepatitis B.
• Has a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive).
• Grade 3 or above peripheral neuropathy.
• Severe allergic history to pemetrexed, paclitaxel, albumin-bound paclitaxel, carboplatin or other preventive drugs.
• Underlying severe or uncontrolled disease.
• Malignant tumors other than NSCLC within 5 years.
• Any medical condition requiring systemic treatment with corticosteroids (prednisone or equivalent at a dose of >10mg/ day) or other immunosuppressive agents within 14 days prior to treatment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery	Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC)	Participants will receive neoadjuvant Tislelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection.
Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery	Tislelizumab	Participants will receive neoadjuvant Tislelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection.
Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery	Carboplatin	Participants will receive neoadjuvant Tislelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection.

Primary Outcome Measures

Name	Time	Method
Resectability rate	At time of surgery	Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.

Secondary Outcome Measures

Name	Time	Method
Perioperative G3-4 Adverse Events (AEs)	Up to 1 month post surgery	The number of participants experiencing an perioperative G3-4 AE will be assessed.
Major pathological response rate (MPR)	At time of surgery	MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.
Pathology complete response rate(pCR)	At time of surgery	pCR rate is defined as the percentage of participants lacking of evidence of viable tumor cells in the pathological examination of resected specimens.
R0 Resection rate	At time of surgery	R0 Resection rate is defined as the percentage of patients who were able to undergo R0 Resection surgery after neoadjuvant therapy.

Trial Locations

Locations (1)

Beijing Tsinghua Chang Gung Hospital; 🇨🇳 Beijing, Beijing, China