Disitamab Vedotin, ERBB2 Gene Duplication, ERBB2 Mutation-Related Tumors, Non Small Cell Lung Cancer
Conditions
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）combined with EGFR or HER2 TKIs, in the aim of providing new treatment strategies for lung cancer patients with HER2 pathway activation.
Interventions
DRUGDisitamab Vedotin
RC48+third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) in treatment naive NSCLC
RC48+third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) after EGFR-TKIs progression
DRUGpyrotinib
RC48+pyrotinib after EGFR-TKIs progression
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: 18 (inclusive) or above, regardless of gender. 2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC, not suitable for radical surgery or radiotherapy (TNM 8th Edition).. 3. HER2 alterations include HER2 gene mutations, gene amplification and HER2 protein over-expression; 4. 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; 5. There is at least one measurable lesion that meets the definition of the RECIST 1.1 standard at baseline. 6. ECOG fitness status score: 0 or 1 point.
Exclusion criteria
1. Central nervous system metastasis or meningeal metastasis with clinical symptoms. 2. Known hypersensitivity or intolerance to any component of the study protocol drug or its excipients. 3. Have a history of severe cardiovascular disease. 4. Have a history of interstitial lung disease or drug-induced interstitial lung disease requiring steroids treatment; radiation pneumonia. 5. Have a history of neurological disorders or mental illnesses, including epilepsy or dementia. 6. Pregnant or lactating women. 7. The researcher believes that the subject is not suitable to participate in this clinical study due to other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC) | Up to 24 months (data cut-off) | Percentage of Participants who have a complete response (CR) or partial response (PR) as assessed by investigator according to RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC) | Up to 24 months (data cut-off) | Defined as the proportion of participants who have a complete response (CR), partial response (PR) or standard disease (SD) as assessed by investigator according to RECIST 1.1 |
| Progression-free survival (PFS) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC) | Up to 24 months (data cut-off) | Defined as time from randomization until progression per RECIST 1.1 as assessed by investigator, or death due to any cause. |
| Duration of Response (DoR) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC) | Up to 24 months (data cut-off) | Defined as the time from the date of first documented response until date of documented progression as assessed by investigator assessment according to RECIST 1.1. |
| Overall Survival (OS) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC) | Up to 24 months (data cut-off) | Defined as time from randomization until the date of death due to any cause. |
Contacts
Primary ContactJie Wang, Dr
Outcome results
None listed