Actively Recruiting
Neoadjuvant Envafolimab Plus Disitamab Vedotin and Carboplatin in Resectable HER2-Mutant Non-Small-Cell Lung Cancer
Led by Guangdong Provincial People's Hospital · Updated on 2024-12-16
25
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single-arm, multi-center, phase II clinical study to evaluate the efficacy and safety of Envafolimab injection (PD-L1) combined with Disitamab Vedotin (HER2 ADC) and Carboplatin for resectable, HER2-Mutant, stage II-IIIB, NSCLC.
CONDITIONS
Official Title
Neoadjuvant Envafolimab Plus Disitamab Vedotin and Carboplatin in Resectable HER2-Mutant Non-Small-Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understanding of the study and willingness to sign informed consent
- Aged between 18 and 75 years, any gender
- Treatment-naive, histologically confirmed resectable stage II, IIIA, or IIIB NSCLC
- PET-CT or CT plus MRI completed before enrollment
- HER2 mutations confirmed by histological specimens
- Measurable lesions according to RECIST v1.1
- Availability of tumor tissue and blood samples for MRD and biomarker testing
- ECOG performance status 0 or 1
- No contraindications to immunotherapy
- Adequate organ function
- Ability to comply with study visits, treatments, and procedures
- Pulmonary function sufficient to tolerate planned surgery
- Negative serum pregnancy test within 3 days before first dose for women of childbearing potential
- Agreement to use effective contraception during the study and for 180 days after last dose
You will not qualify if you...
- Presence of locally advanced, unresectable, or metastatic disease
- Known EGFR, ALK, KRAS, BRAF, ROS1, RET, MET, or NTRK genetic alterations
- Previous systemic antitumor therapy for early NSCLC
- History or current pneumonitis/interstitial lung disease requiring steroid treatment
- Active tuberculosis or infection requiring systemic treatment
- Known or suspected autoimmune disorder or immunodeficiency (with some exceptions)
- Uncontrolled active hepatitis B or active hepatitis C
- Known HIV infection
- Live vaccine within 30 days before first dose
- Prior use of PD-1/PD-L1 agents or other targeted T cell receptor drugs
- Severe allergic reaction to monoclonal antibodies
- Serious or uncontrolled pre-existing diseases including cardiovascular or cerebrovascular events
- Other malignant tumors within 5 years except certain low-risk cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, China
Actively Recruiting
Research Team
W
Wenzhao Zhong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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