Non Small Cell Lung CancerPhase 2NCT05847764
Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations
A Phase 2 study testing RC48+Tislelizumab+carboplatin, RC48+Furmonertinib, 1L and RC48+Furmonertinib, 2L+ in people with Non Small Cell Lung Cancer and ERBB2 Mutation-Related Tumors, run by Sun Yat-sen University at 1 site in China.
Trial summary
Disitamab Vedotin combined therapy 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, RC48
- What is being tested?
- RC48+Tislelizumab+carboplatin, RC48+Furmonertinib, 1L and RC48+Furmonertinib, 2L+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteChina
- Study dates
- May 2023to May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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).".
- Biomarker:
- Arm 1: HER2 alterations, no other driver gene mutations；
- Arm 2: EGFR mutations accompanied by HER2 alterations;
- Arm 3: HER2 gene mutations, no other driver gene alterations;
Show all 13Show fewer
- Number of treatment lines:
- Arm 1-2: patients who have not previously received systemic treatment for advanced diseases;
- Arm3:Failed with at least one line of standard treatment or intolerance;
- Patients who have previously undergone neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy, or radiochemotherapy for the purpose of curing non metastatic diseases must have a disease-free interval of 6 months from the last chemotherapy and/or radiotherapy to the randomization date.
- 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.
- Estimated survival time ≥ 3 months.
Who cannot join
- Central nervous system metastasis or meningeal metastasis with clinical symptoms.
- Have a history of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- Active hepatitis B (hepatitis B virus titer>1000 copies/ml or 200 IU/ml); Hepatitis C virus and syphilis infection.
- Have undergone major organ surgery (excluding puncture biopsy) or have experienced significant trauma within 3 weeks before the first use of the study drug.
- Known hypersensitivity or intolerance to any component of the study protocol drug or its excipients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC With HER2 Alterations, a Phase II Study
Disitamab Vedotin combined therapy 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 mutation (mutation, amplification, protein over-expression) using Disitamab Vedotin（RC48） combined with Tislelizumab or third-generation EGFR-TKI Furmonertinib, in the aim of providing new treatment strategies for lung cancer patients with HER2 pathway activation.
- Being tested
- RC48+Tislelizumab+carboplatin, RC48+Furmonertinib, 1L, RC48+Furmonertinib, 2L+
- 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.
RC48+Tislelizumab+carboplatinDrug
RC48+PD-1/PD-L1 inhibitor+chemo in treatment-naive patients harboring HER2 alterations
RC48+Furmonertinib, 1LDrug
RC48+Furmonertinib in treatment-naive patients harboring EGFR mutations as well as HER2 alterations
RC48+Furmonertinib, 2L+Drug
RC48+Furmonertinib in patients who failed at least one line of standard treatment and harboring HER2 alterations
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: RC48+PD-1/PD-L1 inhibitor | Experimental | Not described Receives: Drug: RC48+Tislelizumab+carboplatin |
| Arm 2: RC48+Furmonertinib, 1L | Experimental | Not described Receives: Drug: RC48+Furmonertinib, 1L |
| Arm 3: RC48+Furmonertinib, 2L+ | Experimental | Not described Receives: Drug: RC48+Furmonertinib, 2L+ |
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 posted8 May 2023
- Study startMay 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionMay 2025 (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 Sun Yat-sen UniversityThe 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
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhang, MD, Sun Yat-sen University
- Investigators
- Li PI Zhang, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847764
- Sponsor's protocol ID
- RCVDODIIR006
- Status last verified
- May 2023
- First submitted
- 21 Mar 2023
- Last updated
- 8 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC With HER2 Alterations, a Phase II Study
- ClinicalTrials.gov ID
- NCT05847764
- Acronym / sponsor ID
- RCVDODIIR006
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 8 May 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 combined therapy 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 mutation (mutation, amplification, protein over-expression) using Disitamab Vedotin（RC48） combined with Tislelizumab or third-generation EGFR-TKI Furmonertinib, 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 |
|---|---|---|
| Arm 1: RC48+PD-1/PD-L1 inhibitor | Experimental | Drug: RC48+Tislelizumab+carboplatin |
| Arm 2: RC48+Furmonertinib, 1L | Experimental | Drug: RC48+Furmonertinib, 1L |
| Arm 3: RC48+Furmonertinib, 2L+ | Experimental | Drug: RC48+Furmonertinib, 2L+ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 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).".
- Biomarker:
- Number of treatment lines:
- Patients who have previously undergone neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy, or radiochemotherapy for the purpose of curing non metastatic diseases must have a disease-free interval of 6 months from the last chemotherapy and/or radiotherapy to the randomization date.
Key exclusion criteria (5 listed)
- Central nervous system metastasis or meningeal metastasis with clinical symptoms.
- Have a history of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
- Active hepatitis B (hepatitis B virus titer>1000 copies/ml or 200 IU/ml); Hepatitis C virus and syphilis infection.
- Have undergone major organ surgery (excluding puncture biopsy) or have experienced significant trauma within 3 weeks before the first use of the study drug.
- Known hypersensitivity or intolerance to any component of the study protocol drug or its excipients.
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 |
|---|---|---|
| RC48+Tislelizumab+carboplatinRC48+PD-1/PD-L1 inhibitor+chemo in treatment-naive patients harboring HER2 alterations | Drug | Arm 1: RC48+PD-1/PD-L1 inhibitor |
| RC48+Furmonertinib, 1LRC48+Furmonertinib in treatment-naive patients harboring EGFR mutations as well as HER2 alterations | Drug | Arm 2: RC48+Furmonertinib, 1L |
| RC48+Furmonertinib, 2L+RC48+Furmonertinib in patients who failed at least one line of standard treatment and harboring HER2 alterations | Drug | Arm 3: RC48+Furmonertinib, 2L+ |
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Li PI Zhang, MD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RC48+Tislelizumab+carboplatin, RC48+Furmonertinib, 1L and RC48+Furmonertinib, 2L+ in people with Non Small Cell Lung Cancer and ERBB2 Mutation-Related Tumors, run by Sun Yat-sen University at 1 site in China.
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 13 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li PI Zhang, MD (020-87343421, zhangli@sysucc.org.cn), 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 8 May 2023.