RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations

Non Small Cell Lung Cancer Clinical Trial

Official title:

Disitamab Vedotin（RC48）Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06185400
• Other study ID #: RCVDODIIR010
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 1, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: December 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Jie Wang, Dr
• Phone: 010-87788219
• Email: zlhuxi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Disitamab Vedotin（RC48）combined with EGFR or HER2 TKIs in locally advanced or metastatic NSCLC Patients with HER2 Alterations.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: December 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Drug:
• Disitamab Vedotin
RC48+third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) in treatment naive NSCLC
• third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib)
RC48+third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) after EGFR-TKIs progression
• pyrotinib
RC48+pyrotinib after EGFR-TKIs progression

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Percentage of Participants who have a complete response (CR) or partial response (PR) as assessed by investigator according to RECIST 1.1	Up to 24 months (data cut-off)
Secondary	Disease control rate (DCR) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)	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	Up to 24 months (data cut-off)
Secondary	Progression-free survival (PFS) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)	Defined as time from randomization until progression per RECIST 1.1 as assessed by investigator, or death due to any cause.	Up to 24 months (data cut-off)
Secondary	Duration of Response (DoR) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)	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.	Up to 24 months (data cut-off)
Secondary	Overall Survival (OS) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)	Defined as time from randomization until the date of death due to any cause.	Up to 24 months (data cut-off)