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

NCT06185400 | Not Yet Recruiting Phase 2

• 1 other identifier: RCVDODIIR010
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Non Small Cell Lung Cancer; ERBB2 Mutation-Related Tumors; ERBB2 Gene Duplication; Disitamab Vedotin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Disease control rate (DCR) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)

  Up to 24 months (data cut-off)

• Progression-free survival (PFS) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)

  Up to 24 months (data cut-off)

• Duration of Response (DoR) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)

  Up to 24 months (data cut-off)

• Overall Survival (OS) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)

  Up to 24 months (data cut-off)

Study Arms (3)

Arm1: Treatment Naive NSCLC

EXPERIMENTAL

RC48+third-generation EGFR TKIs in treatment-naive patients harboring EGFR mutation and HER2 alterations

Drug: Disitamab Vedotin; Drug: third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib)

Arm2: Locally Progressed

EXPERIMENTAL

This cohort includes ERBB2 altered patients after third-generation EGFR-TKIs treatment with locally or slowly progressed disease, who may continue to benefit from third-generation EGFR-TKIs treatment under investigators' evaluation.

Drug: Disitamab Vedotin; Drug: third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib)

Arm3: Extensively Progressed

EXPERIMENTAL

This cohort includes ERBB2 altered patients after third-generation EGFR-TKIs treatment with extensively progressed disease, who may be less likely to benefit from third-generation EGFR-TKIs treatment under investigators' evaluation.

Drug: Disitamab Vedotin; Drug: pyrotinib

Interventions

Disitamab Vedotin DRUG

RC48+third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) in treatment naive NSCLC

Also known as: RC48

Arm1: Treatment Naive NSCLC; Arm2: Locally Progressed; Arm3: Extensively Progressed

third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) DRUG

RC48+third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) after EGFR-TKIs progression

Arm1: Treatment Naive NSCLC; Arm2: Locally Progressed

pyrotinib DRUG

RC48+pyrotinib after EGFR-TKIs progression

Arm3: Extensively Progressed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

disitamab vedotin; aumolertinib; pyrotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jie Wang, Dr

CONTACT

010-87788219; zlhuxi@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Oncology Department

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 29, 2023
• Study Start: February 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 29, 2023

Record last verified: 2023-12