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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04586465
Other study ID # ZDWY.XWK.003
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 10, 2020
Est. completion date June 30, 2022

Study information

Verified date October 2020
Source Fifth Affiliated Hospital, Sun Yat-Sen University
Contact QingDong Cao, MD
Phone 0756-2528825
Email cqd8866@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The neoadjuvant Immune Checkpoint Inhibitor (ICI) or ICI combination with chemotherapy for Non-small cell lung cancer (NSCLC) had induced higher major pathologic response (MPR) and complete pathological response (PCR). However, the RECIST underestimated the therapeutic response of neoadjuvant ICI therapy. In this study, dynamic PET/CT compared with RECEST 1.1 for the prediction of therapeutic response of NSCLC treated with neoadjuvant ICI combination with chemotherapy.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
pembrolizumab, pemetrexed, gemcitabine, cisplatin, carboplatin
Patients will receive 3 cycles pembrolizumab 200mg, fix dose, 60 minute IV infusion combination with chemotherapy. Chemotherapy regimen: ? Eligible patients with non-squamous cell lung cancer, Pemetrexed 500mg/m2, IV infusion on day 1 and cisplatin 75mg/m2 or carboplatin area under the curve (AUC=5), on day 1 of a 3-week schedule for 3 cycles. ? Eligible patients with squamous cell lung cancer. Patients will receive gemcitabine 1250mg/m2 IV on day 1 and day 8, and cisplatin 75mg/m2 or carboplatin AUC=5 on day 1 of a 3-week schedule for 3 cycles

Locations

Country Name City State
China the fifth affiliated hospital of Sun yat-sen university ZhuHai Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Fifth Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Major pathological response 10% or less residual viable tumor cells up to 12 weeks; analysis of surgical resected tumor samples after neoadjuvant therapy
Primary Dynamic SUV change Dynamic PET-CT SUV change up to 12 weeks; analysis change of SUV before and after neoadjuvant therapy
Primary Objective response rate CT image assessment of tumor response according to RECIST 1.1 criteria up to 12 weeks; analysis change of before and after neoadjuvant therapy
Primary uptake rate constant (Ki) changes uptake rate constant (Ki) changes before and after neoadjuvant therapy up to 12 weeks; before and after neoadjuvant therapy
Secondary Progression free survival Time from enrollment to disease progression or death from any cause, whichever occurred first up to 3 years
Secondary Treatment related adverse events the number of adverse events related to ICI or platinum-based chemotherapy as evaluated according to CTCAE v4.0. 12 weeks
Secondary ctDNA change the amount of ctDNA before and after neoadjuvant therapy 12 weeks
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