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

ConditionsNon Small Cell Lung CancerERBB2 Mutation-Related TumorsERBB2 Gene DuplicationDisitamab Vedotin
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Arm1: patients who have not previously received systemic treatment for advanced diseases;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Disitamab Vedotin

    Drug

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

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

    Drug

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

  • pyrotinib

    Drug

    RC48+pyrotinib after EGFR-TKIs progression

Treatment groups

108 Participants
are divided into 3 treatment groups
Group A: Arm1: Treatment Naive NSCLCExperimental treatment 2 interventions
Group B: Arm2: Locally ProgressedExperimental treatment 2 interventions
Group C: Arm3: Extensively ProgressedExperimental treatment 2 interventions

Trial outcomes

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

Time frame
Up to 24 months (data cut-off)

Secondary outcomes

1

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

Time frame
Up to 24 months (data cut-off)
2

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.

Time frame
Up to 24 months (data cut-off)
3

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.

Time frame
Up to 24 months (data cut-off)
4

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.

Time frame
Up to 24 months (data cut-off)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: