Non Small Cell Lung CancerPhase 2NCT06185400
RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations
A Phase 2 study testing Disitamab Vedotin, third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) and pyrotinib in people with Non Small Cell Lung Cancer and ERBB2 Mutation-Related Tumors, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
Disitamab Vedotin（RC48）combined with EGFR or HER2 TKIs in locally advanced or metastatic NSCLC Patients with HER2 Alterations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, ERBB2 Mutation-Related Tumors, ERBB2 Gene Duplication
- What is being tested?
- Disitamab Vedotin, third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) and pyrotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Disitamab Vedotin（RC48）Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations
Disitamab Vedotin（RC48）combined with EGFR or HER2 TKIs in locally advanced or metastatic NSCLC Patients with HER2 Alterations.
Read the 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.
- Conditions
- Non Small Cell Lung Cancer, ERBB2 Mutation-Related Tumors, ERBB2 Gene Duplication, Disitamab Vedotin
- Being tested
- Disitamab Vedotin, third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib), pyrotinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab VedotinDrug
Also called RC48
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
pyrotinibDrug
RC48+pyrotinib after EGFR-TKIs progression
| Study group | Role | What they receive |
|---|---|---|
| Arm1: Treatment Naive NSCLC | Experimental | RC48+third-generation EGFR TKIs in treatment-naive patients harboring EGFR mutation and HER2 alterations Receives: 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. Receives: 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. Receives: Drug: Disitamab Vedotin; Drug: pyrotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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
Measured: Up to 24 months (data cut-off)
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.
Measured: Up to 24 months (data cut-off)
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.
Measured: Up to 24 months (data cut-off)
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.
Measured: Up to 24 months (data cut-off)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 Feb 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185400
- Sponsor's protocol ID
- RCVDODIIR010
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disitamab Vedotin（RC48）Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations
- ClinicalTrials.gov ID
- NCT06185400
- Acronym / sponsor ID
- RCVDODIIR010
- Conditions
- Non Small Cell Lung Cancer, ERBB2 Mutation-Related Tumors, ERBB2 Gene Duplication, Disitamab Vedotin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm1: Treatment Naive NSCLC | Experimental | Drug: Disitamab Vedotin, Drug: third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib)RC48+third-generation EGFR TKIs in treatment-naive patients harboring EGFR mutation and HER2 alterations |
| Arm2: Locally Progressed | Experimental | Drug: Disitamab Vedotin, Drug: third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib)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. |
| Arm3: Extensively Progressed | Experimental | Drug: Disitamab Vedotin, Drug: pyrotinibThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- There is at least one measurable lesion that meets the definition of the RECIST 1.1 standard at baseline.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disitamab VedotinAlso: RC48RC48+third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) in treatment naive NSCLC | Drug | Arm1: Treatment Naive NSCLC, Arm2: Locally Progressed, Arm3: Extensively Progressed |
| third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib)RC48+third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) after EGFR-TKIs progression | Drug | Arm1: Treatment Naive NSCLC, Arm2: Locally Progressed |
| pyrotinibRC48+pyrotinib after EGFR-TKIs progression | Drug | Arm3: Extensively Progressed |
Primary outcome
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)
Time frame: Up to 24 months (data cut-off)
Percentage of Participants who have a complete response (CR) or partial response (PR) as assessed by investigator according to RECIST 1.1
4 secondary outcomes
Disease control rate (DCR) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)
Time frame: Up to 24 months (data cut-off)
Progression-free survival (PFS) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)
Time frame: Up to 24 months (data cut-off)
Duration of Response (DoR) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)
Time frame: Up to 24 months (data cut-off)
Overall Survival (OS) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)
Time frame: Up to 24 months (data cut-off)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Disitamab Vedotin, third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) and pyrotinib in people with Non Small Cell Lung Cancer and ERBB2 Mutation-Related Tumors, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Wang, Dr (010-87788219, zlhuxi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Up to 24 months (data cut-off)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.