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NOT YET RECRUITING
NCT06475755
PHASE2

Neoadjuvant/Adjuvant Tislelizumab Combined With Anlotinib and Platinum Doublet Chemotherapy With Resectable NSCLC

Sponsor: Tang-Du Hospital

View on ClinicalTrials.gov

Summary

This is a Phase II, prospective, randomized, open label, controlled, multi-center study, aim to evaluate the activity of Tislelizumab and Anlotinib and chemotherapy compared with Tislelizumab and chemotherapy before surgery, followed by Tislelizumab alone as adjuvant therapy. The primary objective of this study is to evaluate and compare pathological complete response rate(pCR).

Official title: A Phase II, Prospective, Randomized, Open Label, Multi-center Study of Tislelizumab Combined With Anlotinib and Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant With Resectable Stage II-IIIB Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

178

Start Date

2024-06-30

Completion Date

2027-12-31

Last Updated

2024-06-26

Healthy Volunteers

No

Interventions

DRUG

Immunochemotherapy combined with antiangiogenic

neoadjuvant: Tislelizumab 200mg iv,d1,q3w, Anlotinib 10mg,po,qd1-14,q3w, Cisplatin 75 mg/m\^2 by IV infusion Q3W, given on cycle day 1 Carboplatin AUC of 5 on Day 1 of each 3-week cycle Paclitaxel 175mg/m2 on Day 1 of each 3-week cycle(SQ only) Albumin-bound paclitaxel 260mg/m2,on D1 IV infusion Q3W or 130mg/m2 on D1D8 IV infusion Q3W for each cycle(SQ only) Pemetrexed 500 mg/m2 on Day 1 of each 3-week cycle(NSQ only) Adjuvant: 4 weeks(±7 Days) following surgery, participants receive no more than 16 cycles (cycle length: 3 weeks) of Tislelizumab \[200 mg, IV; given on cycle day 1\].

DRUG

Immunochemotherapy

neoadjuvant:Tislelizumab 200mg iv,d1,q3w, Cisplatin 75 mg/m\^2 by IV infusion Q3W, given on cycle day 1 Carboplatin AUC of 5 on Day 1 of each 3-week cycle Paclitaxel 175mg/m2 on Day 1 of each 3-week cycle(SQ only) Albumin-bound paclitaxel 260mg/m2,on D1 IV infusion Q3W or 130mg/m2 on D1D8 IV infusion Q3W for each cycle(SQ only) Pemetrexed 500 mg/m2 on Day 1 of each 3-week cycle(NSQ only) Adjuvant: 4 weeks(±7 Days) following surgery, participants receive no more than 16 cycles (cycle length: 3 weeks) of Tislelizumab \[200 mg, IV; given on cycle day 1\].

Locations (1)

Tangdu Hospital of the Fourth Millitary Medical University

Xi'an, Shaanxi, China