The Efficacy and Safety of Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIB-IIIA Non-small Cell Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIA-IIIA Non-small Cell Lung Cancer

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
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⁃ Patients must volunteer participating in clinical trial; patients fully understand and sign the Informed Consent Form (ICF)

⁃ 18 \

• 70 years old, gender not limited

⁃ Histologically confirmed resectable stage IIA-IIIA NSCLC without prior treatment

⁃ Patients must have at least one target lesion to be used to assess response on this protocol as defined by RECIST 1.1

⁃ Agree to provide PD-L1 immune tissue sections and corresponding pathology reports for biomarker evaluation (Tumor tissue samples must be fresh or archived samples obtained within 3 months before enrollment

⁃ Have a performance status of 0 or 1 on the ECOG Performance Scale

⁃ Good organ function: ANC ≥ 1500/μL; PLT ≥ 100000/μL; HB ≥ 10.0g/dL; CR ≤ 1.5 × ULN or CrCl ≥ 60 mL/min (Use Cock-Gault formula); TB ≤ 1.5 × ULN (For patients with total bilirubin levels \> 1.5 × ULN, direct bilirubin is within normal limits); AST and ALT ≤ 2.5 × ULN; TSH is within normal limits. Note: If TSH is not within the normal range at baseline, if T3 and free T4 are within the normal range, then the patient can still meet the inclusion criteria. IN、RPT、APTT≤1.5×ULN

⁃ Patients must volunteer and be able to follow research plan visits, treatment plans, laboratory tests, and other research procedures

⁃ According to the surgeon's assessment, the total lung function can withstand the proposed lung resection

⁃ Within 3 days before medication,the serum of fertile woman must be tested by hcg,and the result is negative. Fertile women can use high effective method for contraception in the duration of clinical trail and 180 days after last Administration

Locations
Other Locations
China
People's hospital of northern jiangsu
RECRUITING
Yangzhou
Contact Information
Primary
Wang Buhai, doctor
wbhself@sina.com
18051062288
Time Frame
Start Date: 2022-08-08
Estimated Completion Date: 2026-05-30
Participants
Target number of participants: 20
Treatments
Experimental: Toripalimab
Sponsors
Collaborators: Shanghai Junshi Bioscience Co., Ltd.
Leads: Northern Jiangsu People's Hospital

This content was sourced from clinicaltrials.gov