Neoadjuvant Almonertinib Followed by Adebrelimab-based Chemo-immunotherapy in II-IIIB EGFR-mutant Non-small Cell Lung Cancer, a Single Arm, Phase II Study
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Male or female，Age: 18 Years and older,
• Subjects voluntarily joined the study and signed informed consent,
• pathological proven resectable stage II-IIIB non small cell lung cancer (AJCC 8th edition),
• ECOG PS=0 or 1,
• resectable or potentially resectable, or resectability discussed by MDT,
• harboring EGFR mutation: Ex19del, L858R, T790M, G719X, Exon20 insertions, S768I or L861Q
• measurable lesion as per RECIST1.1.
Locations
Other Locations
China
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
RECRUITING
Guangzhou
Contact Information
Primary
Wen-zhao Zhong, PhD
syzhongwenzhao@scut.edu.cn
+862083827812
Backup
Jun-Tao Lin, PhD
237801160@qq.com
Time Frame
Start Date: 2024-04
Estimated Completion Date: 2027-09
Participants
Target number of participants: 32
Treatments
Experimental: Almonertinib and Chemo-immunotherapy
6 weeks of almonertinib followed by 3 cycles of neoadjuvant adebrelimab (1200mg every 3 weeks) with nab-paclitaxel and carboplatin (nab-paclitaxel 135 mg/m2, d1 and d8, and carboplatin AUC 5, d1 every 3 weeks) will be administered before surgery, followed by optional adjuvant treatment including EGFR-TKIs up to 3 years or immunotherapy for up to 1 year or till disease progression or unacceptable toxicity.
Related Therapeutic Areas
Sponsors
Leads: Guangdong Provincial People's Hospital