Ignite Creation Date:
2024-05-06 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05157542
Status:
UNKNOWN
Last Update Posted:
2021-12-15
First Post:
2021-05-24
Brief Title:
Neoadjuvant LDRT Combined With Durvalumab in Potentially Resectable Stage III NSCLC
Sponsor:
Juan LI MD
Organization:
Sichuan Cancer Hospital and Research Institute
Study Overview
Official Title:
A Phase Ib Trial on the Safety and Feasibility of Neoadjuvant Low Dose Radiation Chemotherapy and Durvalumab for Potentially Resectable Stage III Non-small Cell Lung Cancer NSCLC
Status:
UNKNOWN
Status Verified Date:
2021-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction Although PACIFIC regimen definitive concurrent chemoradiotherapy CRT followed by Durvalumab consolidation therapy is considered the standard of care for most of stage III NSCLC patients neoadjuvant immunotherapy combined with chemotherapy followed by surgery has shown the trend to be considered for some potentially resectable patients The rationales for neoadjuvant treatment are tumor regression effect before surgery early eradication of micrometastasis Recently the investigators also find some clinical trials exploring the adding of 45 Gy in 25 fractions radiation to the combination of chemotherapy and immunotherapy neoadjuvant therapy and the investigators could see the safety is the most concern especially the pneumonitis incidence Low dose radiation could help control the toxicity induced by radiation and has synergic effect with immunotherapy The aim of this phase Ib study is to assess the safety and feasibility of the combination of the concurrent low dose radiation chemotherapy and Durvalumab neoadjuvant therapy to explore which radiation dose is the best among our three-dose designs and evaluate if the combining neoadjuvant therapy could further improve MPR in the meantime no severe toxicities especially the grade 3-4 pneumonitis would happen
Method 9 eligible patients with histologically confirmed NSCLC potentially resectable clinical stage III according to the American Joint Committee on Cancer 8th staging system are enrolled Patients receive Chemo Day1 and 22 nanoparticle albumin-bound paclitaxel 260 mgm2 and carboplatin AUC 5 and durvalumab Day 1 and 22 1500mg and radiotherapy of 10 Gy in 5 fractions 20 Gy in 10 fractions 30 Gy in 15 fractions respectively in our three groups from Day1 followed by surgery After surgery patients are suggested to be treated with durvalumab for one year every 4weeks 1500 mg The primary endpoints are safety and tolerability The secondary endpoints are objective response rate ORR event-free survival EFS overall survival OS pathologic complete response pCR and major pathologic responseMPR in the primary tumor biomarker analysis of PD-L1 using cancer tissue and LIPI ctDNA using blood sample will be conducted pre-and post- neoadjuvant and post-surgery
Method 9 eligible patients with histologically confirmed NSCLC potentially resectable clinical stage III according to the American Joint Committee on Cancer 8th staging system are enrolled Patients receive Chemo Day1 and 22 nanoparticle albumin-bound paclitaxel 260 mgm2 and carboplatin AUC 5 and durvalumab Day 1 and 22 1500mg and radiotherapy of 10 Gy in 5 fractions 20 Gy in 10 fractions 30 Gy in 15 fractions respectively in our three groups from Day1 followed by surgery After surgery patients are suggested to be treated with durvalumab for one year every 4weeks 1500 mg The primary endpoints are safety and tolerability The secondary endpoints are objective response rate ORR event-free survival EFS overall survival OS pathologic complete response pCR and major pathologic responseMPR in the primary tumor biomarker analysis of PD-L1 using cancer tissue and LIPI ctDNA using blood sample will be conducted pre-and post- neoadjuvant and post-surgery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None