RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations
NCT ID: NCT06185400
Last Updated: 2023-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
108 participants
INTERVENTIONAL
2024-02-01
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm1: Treatment Naive NSCLC
RC48+third-generation EGFR TKIs in treatment-naive patients harboring EGFR mutation and HER2 alterations
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
Arm2: Locally Progressed
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.
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
Arm3: Extensively Progressed
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.
Disitamab Vedotin
RC48+third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) in treatment naive NSCLC
pyrotinib
RC48+pyrotinib after EGFR-TKIs progression
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Jie Wang
Head of Oncology Department
Central Contacts
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Other Identifiers
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RCVDODIIR010
Identifier Type: -
Identifier Source: org_study_id