Status:
NOT_YET_RECRUITING
RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Non Small Cell Lung Cancer
ERBB2 Mutation-Related Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Disitamab Vedotin（RC48）combined with EGFR or HER2 TKIs in locally advanced or metastatic NSCLC Patients with HER2 Alterations.
Detailed Description
This study will explore the treatment of locally advanced or metastatic non-small cell lung cancer with HER2 mutation, amplification, or HER2 protein overexpression, using Disitamab Vedotin（RC48）combi...
Eligibility Criteria
Inclusion
- Age: 18 (inclusive) or above, regardless of gender.
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC, not suitable for radical surgery or radiotherapy (TNM 8th Edition).".
- HER2 alterations include HER2 gene mutations, gene amplification and HER2 protein over-expression;
- Number of treatment lines:
- Arm1: patients who have not previously received systemic treatment for advanced diseases;
- Arm2: Previously received first line of third-generation EGFR-TKIs treatment with local progression, oligometastasis, or slow progression, and evaluated by the researchers to continue to benefit from third-generation EGFR-TKIs treatment;
- Arm3: Previously received first line of third-generation EGFR-TKIs treatment with extensively progression, and evaluated by the researchers not likely to continue to benefit from third-generation EGFR-TKIs treatment;
- There is at least one measurable lesion that meets the definition of the RECIST 1.1 standard at baseline.
- ECOG fitness status score: 0 or 1 point.
Exclusion
- Central nervous system metastasis or meningeal metastasis with clinical symptoms.
- Known hypersensitivity or intolerance to any component of the study protocol drug or its excipients.
- Have a history of severe cardiovascular disease.
- Have a history of interstitial lung disease or drug-induced interstitial lung disease requiring steroids treatment; radiation pneumonia.
- Have a history of neurological disorders or mental illnesses, including epilepsy or dementia.
- Pregnant or lactating women.
- The researcher believes that the subject is not suitable to participate in this clinical study due to other reasons.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06185400
Start Date
February 1 2024
End Date
December 1 2026
Last Update
December 29 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.