NSCLCPhase 2CVL009-2001NCT06029816
Neratinib Tablets in the Treatment of Advanced NSCLC With Rare EGFR Mutations
A Phase 2 study testing Neratinib tablets in people with NSCLC, run by Convalife (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
Single-arm, open-label, multicenter phase II clinical study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Neratinib tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2023to 30 Dec 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 years;
- Histologically or cytologically confirmed non-small cell lung cancer, stage IIIB or IV according to IASLC 2009;
- Tissue or blood samples are confirmed by the central laboratory or research center as rare EGFR mutations, including exon 18 G719X, E709X, etc., S768I in exon 20 and at least one of the L861Q mutations in exon 21;
- Ineffective or intolerant to standard treatment regimens, and disease progression after treatment;
- The number of previous chemotherapy regimens does not exceed 2 (a. replacement of platinum drugs for drug toxicity reasons is counted as a regimen; b. postoperative adjuvant chemotherapy, from the end of treatment to recurrence > 6 months is not counted as a previous chemotherapy regimen);
- ECOG standard score 0-1;
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- Predicted survival ≥ 12 weeks;
- Presence of measurable lesions according to RECIST 1.1: At least one lesion that is not irradiated, ≥ 10 mm in long diameter (lymph node lesions need to be ≥ 15 mm in short diameter), and can be accurately measured at baseline and can be repeatedly measured under CT or MRI; If the subject only has post-radiotherapy lesion, and this lesion has been confirmed as imaging progression and can be measured, it can be selected as target lesion (except for brain lesion), and brain lesion is not included as measurable target lesion;
- Subjects with asymptomatic brain metastases or brain metastases can be included in this study when the following conditions are met: brain metastases are treated and stable, such as clinical examination and brain scan (MRI or CT scan) confirmed at least 4 no evidence of lesion progression during the screening period, no neurological symptoms and no need for corticosteroid therapy. If the subject has brain metastases that have been treated surgically or with radiation, a time window of ≥ 4 weeks is required before the first dose of nelatidine tablets to ensure that adverse events associated with radiation or surgical treatment have decreased to ≤ Grade 1;
- Bone marrow reserve or organ function needs to meet the following laboratory value criteria:
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
- Platelet count (PLT) ≥ 90 × 109/L
- Hemoglobin (Hb) ≥ 90 g/L
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; ≤ 5 × ULN in the presence of liver metastases
- Serum total bilirubin (TBIL) ≤ 1.5 × ULN
- Blood urea nitrogen/urea nitrogen (UREA/BUN) and creatinine (Cr) ≤ 1.5 × ULN
- Coagulation international normalized ratio (INR) ≤ 1.5 ULN and APTT ≤ 1.5 ULN;
- Urine protein < 2 + (when baseline urine protein is 2 +, 24-hour urine protein quantification should be performed, and inclusion can only be made when ≤ 1 g) * ULN = upper limit of normal
- Women of childbearing potential should agree to take contraceptive measures (such as intrauterine device, contraceptive or condom) during the study and within 6 months after the end of the study; 7. Blood pregnancy test is negative before enrollment and patients must be non-lactating; men should agree to take contraceptive measures during the study and within 6 months after the end of the study;
- Patients voluntarily participate in this study, sign the informed consent form, and have good compliance.
Who cannot join
- Received any of the following treatments: 1. previous treatment with any EGFR tyrosine kinase inhibitor; 2. major surgery 4 times before the first dose of the study drug; c. 4 times before the first dose of the study drug, more than 30% of bone marrow irradiation, or extensive radiotherapy; d. within 7 days before the first dose of the study drug, the use of CYP3A4 strong inhibitors, inducers or drugs that are CYP3A4 sensitive substrates with a narrow therapeutic window;
- Patients with other malignant tumors and need standard treatment or major surgery within 2 years after the first dose of study treatment;
- In the beginning of the study treatment, there are greater than CTCAE grade 1 failed to alleviate the residual toxicity of previous treatment, except alopecia and previous chemotherapy-induced grade 2 neurotoxicity;
- Spinal cord compression or brain metastasis, unless asymptomatic, stable condition, and not requiring steroid therapy for at least 2 weeks before the first dose of study treatment;
- Poor blood pressure control after drug treatment (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg);
- Patients with severe or uncontrollable systemic diseases, including gastrointestinal ulcers and bleeding and other diseases;
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- There are many factors that affect the oral administration of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction and other gastrointestinal diseases or abnormalities);
- 12 ECG: QTcF: female > 470 ms, male > 450 ms;
- Echocardiography: score (LVEF) ≤ 50%;
- History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or any evidence of clinically active interstitial lung disease;
- History of immunodeficiency, including HIV test positive, active hepatitis B/C (HBV-DNA > 1000 IU/mL or > 2500 copies/mL, HCV-RNA ≥ 10 ³ copies/mL) or suffering from other acquired, congenital immunodeficiency diseases, or history of organ transplantation;
- Women who are lactating or have a positive pregnancy test result before the first dose of study treatment;
- 4 Participated in any other drug clinical study before the first dose;
- The investigator judges that there are any patients who endanger the patient's safety, interfere with the study assessment, and have poor compliance;
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ran Xu, 020-87343565, xuran@sysucc.org.cn
Wenfeng Fang
About this study
Official title: A Single-arm, Open-label, Multicenter Phase II Clinical Study of Neratinib Tablets in the Treatment of Advanced NSCLC With Rare EGFR Mutations
Single-arm, open-label, multicenter phase II clinical study
Read the detailed description
Fourteen patients each had three mutation sites and 42 patients were co-enrolled，To evaluate the objective response rate (ORR) of neratinib Tablets in advanced NSCLC with rare EGFR mutations (including G719X, E709X in exon 18, S768I in exon 20 and L861Q in exon 21).
- Conditions
- NSCLC
- Being tested
- Neratinib tablets
- Keywords
- NSCLC, EGFR, Neratinib tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neratinib tabletsDrug
Also called Epilepsy
Neratinib tablets
| Study group | Role | What they receive |
|---|---|---|
| Arm1-Exon 18 | Experimental | Exon 18 G719X, E709X, etc，Up to 14 patients will be enrolled in this group and will be treated with neratinib tablets in 28-day cycles， Receives: Drug: Neratinib tablets |
| Arm2-Exon 20 | Experimental | S768I in exon 20，Up to 14 patients will be enrolled in this group and will be treated with neratinib tablets in 28-day cycles， Receives: Drug: Neratinib tablets |
| Arm3-Exon 21 | Experimental | L861Q of exon 21，Up to 14 patients will be enrolled in this group and will be treated with neratinib tablets in 28-day cycles， Receives: Drug: Neratinib tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
IRC-assessed objective response rate (ORR)
IRC-assessed objective response rate (ORR)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start20 Nov 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- 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
- Model description
- Fourteen patients each had three mutation sites and 42 patients were co-enrolled
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Convalife (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wenfeng Fang, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029816
- Sponsor's protocol ID
- CVL009-2001
- Other IDs
- Chinadrugtrials
- Acronym
- CVL009-2001
- Status last verified
- Sep 2023
- First submitted
- 31 Jul 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Multicenter Phase II Clinical Study of Neratinib Tablets in the Treatment of Advanced NSCLC With Rare EGFR Mutations
- ClinicalTrials.gov ID
- NCT06029816
- Acronym / sponsor ID
- CVL009-2001 / CVL009-2001
- Conditions
- NSCLC
- Keywords
- NSCLC, EGFR, Neratinib tablets
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Convalife (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 8 Sep 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.
Single-arm, open-label, multicenter phase II clinical study
Detailed description
Fourteen patients each had three mutation sites and 42 patients were co-enrolled，To evaluate the objective response rate (ORR) of neratinib Tablets in advanced NSCLC with rare EGFR mutations (including G719X, E709X in exon 18, S768I in exon 20 and L861Q in exon 21).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Fourteen patients each had three mutation sites and 42 patients were co-enrolled
| Arm | Type | Receives |
|---|---|---|
| Arm1-Exon 18 | Experimental | Drug: Neratinib tabletsExon 18 G719X, E709X, etc，Up to 14 patients will be enrolled in this group and will be treated with neratinib tablets in 28-day cycles， |
| Arm2-Exon 20 | Experimental | Drug: Neratinib tabletsS768I in exon 20，Up to 14 patients will be enrolled in this group and will be treated with neratinib tablets in 28-day cycles， |
| Arm3-Exon 21 | Experimental | Drug: Neratinib tabletsL861Q of exon 21，Up to 14 patients will be enrolled in this group and will be treated with neratinib tablets in 28-day cycles， |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age ≥ 18 years;
- Histologically or cytologically confirmed non-small cell lung cancer, stage IIIB or IV according to IASLC 2009;
- Tissue or blood samples are confirmed by the central laboratory or research center as rare EGFR mutations, including exon 18 G719X, E709X, etc., S768I in exon 20 and at least one of the L861Q mutations in exon 21;
- Ineffective or intolerant to standard treatment regimens, and disease progression after treatment;
- The number of previous chemotherapy regimens does not exceed 2 (a. replacement of platinum drugs for drug toxicity reasons is counted as a regimen; b. postoperative adjuvant chemotherapy, from the end of treatment to recurrence > 6 months is not counted as a previous chemotherapy regimen);
Key exclusion criteria (14 listed)
- Received any of the following treatments: 1. previous treatment with any EGFR tyrosine kinase inhibitor; 2. major surgery 4 times before the first dose of the study drug; c. 4 times before the first dose of the study drug, more than 30% of bone marrow irradiation, or extensive radiotherapy; d. within 7 days before the first dose of the study drug, the use of CYP3A4 strong inhibitors, inducers or drugs that are CYP3A4 sensitive substrates with a narrow therapeutic window;
- Patients with other malignant tumors and need standard treatment or major surgery within 2 years after the first dose of study treatment;
- In the beginning of the study treatment, there are greater than CTCAE grade 1 failed to alleviate the residual toxicity of previous treatment, except alopecia and previous chemotherapy-induced grade 2 neurotoxicity;
- Spinal cord compression or brain metastasis, unless asymptomatic, stable condition, and not requiring steroid therapy for at least 2 weeks before the first dose of study treatment;
- Poor blood pressure control after drug treatment (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg);
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 |
|---|---|---|
| Neratinib tabletsAlso: EpilepsyNeratinib tablets | Drug | Arm1-Exon 18, Arm2-Exon 20, Arm3-Exon 21 |
Primary outcome
IRC-assessed objective response rate (ORR)
Time frame: Through study completion, an average of 1 year
IRC-assessed objective response rate (ORR)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 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.
Wenfeng Fang 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 Neratinib tablets in people with NSCLC, run by Convalife (Shanghai) Co., Ltd. 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 20 inclusion and 14 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 Sep 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 Qiong Wang (（021）6877 3638, qiong.wang@convalife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IRC-assessed objective response rate (ORR) (time frame: Through study completion, an average of 1 year). 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 Sep 2023.