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Trial Title:
Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC
NCT ID:
NCT06300424
Condition:
Non Small Cell Lung Cancer
EGFR Gene Mutation
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Carboplatin
Conditions: Keywords:
non small cell lung cancer
neoadjuvant therapy
immunotherapy
EGFR
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
almonertinib
Description:
110mg qd
Arm group label:
Almonertinib and Chemo-immunotherapy
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
AUC 5, d1 every 3 weeks
Arm group label:
Almonertinib and Chemo-immunotherapy
Intervention type:
Drug
Intervention name:
Nab paclitaxel
Description:
135 mg/m2, d1,d8 every 3 weeks
Arm group label:
Almonertinib and Chemo-immunotherapy
Summary:
Phase II, single-arm, open-label study that assess clinical feasibility and safety of
neoadjuvant almonertinib followed by 3 cycles neoadjuvant adebrelimab plus chemotherapy
in EGFR-mutant stage IIA-IIIB NSCLC followed by surgery, adjuvant treatment was upon
investigators' decisions.
Detailed description:
This study plans to include 32 eligible II-IIIB non small cell lung cancer (NSCLC),
patients will receive 6 weeks of almonertinib, and to avoid overlap of interstitial lung
disease (ILD) and immune-related pneumonitis, 2 weeks of washout period was designed
before 3 cycles of adebrelimab + doublet platinum-based chemotherapy is administered.
Dynamic blood samples before, during or after neoadjuvant treatment will be obtained for
exploratory analysis. Patients with local disease and resectable or potentially
resectable NSCLC will receive anatomic resection. Patients who progress upon neoadjuvant
treatment and further assessed as unresectable disease will be scheduled for local
radiation or other potential subsequent treatment regarding multidisciplinary discussion.
After completion of local treatment (surgery or radiation), patients will undergo
optional adjuvant treatment including epidermal growth factor receptor tyrosine kinase
inhibitor (EGFR-TKI) or immunotherapy upon investigators' consideration or CT
surveillance. Patients will be follow-up within 5 years after surgery. The primary
endpoint of this study is major pathological response (MPR) defined as no more than 10%
residual tumor found in primary lung cancer as per International Association for the
Study of Lung Cancer (IASLC) criteria.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or femaleļ¼Age: 18 Years and older,
2. Subjects voluntarily joined the study and signed informed consent,
3. pathological proven resectable stage II-IIIB non small cell lung cancer (AJCC 8th
edition),
4. ECOG PS=0 or 1,
5. resectable or potentially resectable, or resectability discussed by MDT,
6. harboring EGFR mutation: Ex19del, L858R, T790M, G719X, Exon20 insertions, S768I or
L861Q
7. measurable lesion as per RECIST1.1.
Exclusion Criteria:
1. pathologica or cytological proven small cell lung cancer, mixed small cell lung
cancer or other than non small cell lung cancer,
2. non small cell lung cancer harboring other driver gene alteration with approved
targeted drugs,
3. with malignant plural effusion,
4. previous treatment to non small cell lung cancer other than this regimen,
5. received thoracic radiotherapy,
6. currently enrolled in other clinical trial,
7. active or known or suspected autoimmune disease.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Status:
Recruiting
Contact:
Last name:
Wen-zhao Zhong, PhD
Phone:
+86 20 83827812
Phone ext:
51221
Email:
syzhongwenzhao@scut.edu.cn
Contact backup:
Last name:
Jun-Tao Lin, PhD
Email:
237801160@qq.com
Investigator:
Last name:
Wen-zhao Zhong, PhD
Email:
Principal Investigator
Investigator:
Last name:
Jun-Tao Lin, PhD
Email:
Sub-Investigator
Start date:
April 2024
Completion date:
September 2027
Lead sponsor:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Source:
Guangdong Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06300424
