Clinical trial NCT06185400: RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations
Official title: Disitamab Vedotin（RC48）Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
ERBB2 Mutation-Related Tumors
ERBB2 Gene Duplication
Disitamab Vedotin
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: Up to 24 months (data cut-off)
Secondary outcomes:
measure: Disease control rate (DCR) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)
timeFrame: Up to 24 months (data cut-off)
measure: Progression-free survival (PFS) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)
timeFrame: Up to 24 months (data cut-off)
measure: Duration of Response (DoR) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)
timeFrame: Up to 24 months (data cut-off)
measure: Overall Survival (OS) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)
timeFrame: Up to 24 months (data cut-off)
Other outcomes:
Locations:
Study officials:
References: