Safety of AlmonertinibPhase 2NCT04785742
Almonertinib for Advanced NSCLC Patients With Rare Mutations in EGFR
A Phase 2 study testing Almonertinib in people with Safety of Almonertinib, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a multicenter, open, phase II clinical trial evaluating the safety and efficacy of high-dose almonertinib in the treatment of rare mutations in locally advanced or metastatic NSCLC patients with EGFR mutations (excluding exon 19 deletion or rare mutations outside L858R). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Safety of Almonertinib
- What is being tested?
- Almonertinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2020to 31 Dec 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 18 ≤ age ≤75, regardless of gender. 2. Histologically confirmed locally advanced or metastatic non-scaly NSCLC (including stage IIIB-IV patients who relapsed after previous surgical treatment or were newly diagnosed). According to AJCC edition 8 lung cancer staging criteria).
- 3. Previous treatment with second-line chemotherapy (no EGFR-TKI) is allowed. 4. Positive EGFR driver mutation (rare mutation other than 19 exon deletion or L858R) detected by tumor tissue or blood samples.
- 5. The Eastern Tumor Tissue Cooperative Group (ECOG) physical status score was 0 or 1 and did not deteriorate in the previous 2 weeks, with a minimum expected survival of 12 weeks.
- 6. The patient had at least one tumor lesion that had not received previous local treatment such as irradiation, nor had he received biopsy during the screening period, and it could be accurately measured at baseline, with the longest diameter ≥ 10mm at baseline (short diameter ≥ 15mm for lymph nodes). The measurement method chosen is suitable for accurate repeated measurements and can be computed tomography (CT) or magnetic resonance imaging (MRI). If there is only one measurable lesion and no previous local treatment such as irradiation, it may be accepted as the target lesion, and a baseline evaluation of the tumor lesion shall be conducted at least 14 days after the diagnostic biopsy.
- 7. For fertile women, appropriate contraception should be used and breastfeeding should not be performed for 3 months from screening to discontinuation of study treatment. A pregnancy test is negative before administration, or there is no proven risk of pregnancy if one of the following criteria is met:
- Postmenopause is defined as amenorrhea over the age of 50 and at least 12 months after cessation of all exogenous hormone replacement therapy.
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- Women younger than 50 years of age may also be considered postmenopausal if they stop all exogenous hormone therapy for 12 months or more and their luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the laboratory post-menopausal reference range.
- Has undergone irreversible sterilization, including hysterectomy, bilateral oophorectomy or bilateral salpingectomy, except for bilateral tubal ligation.
- 8. Male patients should use barrier contraception (i.e., condoms) from screening until 3 months after treatment is discontinued.
- 9. The subject is willing to participate and sign the informed consent in person.
Who cannot join
- 1. Have received any of the following treatments:
- Patients who underwent major surgery within 4 weeks prior to the first dosing of the study drug;
- Patients who received more than 30% bone marrow irradiation or received large area radiotherapy within 4 weeks prior to the first dosing of the study drug;
- Study drugs that had used a CYP3A4 inhibitor, inducer, or a narrow therapeutic window with a CYP3A4-sensitive substrate within 7 days before first administration.
- 2. Patients with other malignancies requiring standard treatment or major surgery within 2 years of the first dosing of study therapy.
- 3. At the start of the study, there were unmitigated residual toxicity from previous treatment greater than CTCAE grade 1, except for grade 2 neurotoxicity caused by hair loss and previous chemotherapy.
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- 4. Spinal cord compression or brain metastasis, unless asymptomatic, stable, and does not require steroid therapy for at least 2 weeks prior to first dosing of study therapy.
- 5. Any serious or poorly controlled systemic disease, as determined by the investigator, such as poorly controlled hypertension, active bleeding susceptibility, or active infection. There is no need to screen for chronic diseases.
- 6. Full absorption of amitinib may be affected by refractory nausea, vomiting, or chronic gastrointestinal disorders, inability to swallow study drugs, or previous extensive enterectomy.
- 7. Satisfy one of the following cardiac test results:
- Average corrected QT interval (QTC) > 470 msec from three resting electrocardiogram (ECG) examinations, QT interval correction (QTCF) was performed using Fridericia's formula;
- Resting ECG suggests the presence of a variety of clinically significant rhythm, conduction, or ECG morphological abnormalities (such as complete left bundle branch block, degree 3 atrioventricular block, degree 2 atrioventricular block, and PR interphase > 250 Msec);
- The presence of any factors that increase the risk of prolonged QTC or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, a family history of long QT syndrome or sudden unexplained death of an immediate family member under 40 years of age, or any combination drug that prolongs QT interval;
- Left ventricular ejection fraction (LVEF) ≤40%.
- 8. Any history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid treatment, or evidence of clinically active interstitial lung disease.
- 9. Bone marrow reserve or organ function is insufficient, reaching the following laboratory limits:
- Hypoalbuminemia:Absolute neutrophil count <1.5×109 / L;
- Thrombocytopenia:Platelet count <100×109 / L;
- Hypoproteinemia:Hemoglobin <90 g/L (<9 g/dL);
- D.Liver dysfunction.If there is no definite liver metastasis, alanine aminotransferase > is 2.5 times the upper normal limit (ULN); If there is liver metastasis, alanine aminotransferase > 5×ULN;
- Liver dysfunction.If there is no definite liver metastasis, aspartic aminotransferase > 2.5×ULN; If there is liver metastasis, aspartate aminotransaminase > 5×ULN.
- Hyperbilirubinemia.If there is no definite liver metastasis, total bilirubin > 1.5×ULN; Or Gilbert syndrome (unbound hyperbilirubinemia) or liver metastasis, total bilirubin > 3×ULN;
- Creatinine > 1.5×ULN and creatinine clearance <50 mL/min (calculated by Cockcroft - Gault formula); Creatinine clearance needs to be confirmed only when creatinine > 1.5×ULN.
- 10. Women who are lactating or who have positive blood or urine pregnancy test results within 3 days prior to the first dosing of study treatment.
- 11.Hypersensitivity: A history of hypersensitivity to any active or inactive ingredient of almonertinib or to drugs similar in chemical structure to or similar to almonertinib.
- 12. Any serious or uncontrolled ocular lesions that may, in the judgment of the physician, increase the patient's safety risk.
- 13. Patients identified by the investigator as likely to have poor compliance with study procedures and requirements.
- 14. Patients identified by the investigator as having any condition that jeopardizes patient safety or interferes with study evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Multicenter Phase II Clinical Study to Evaluate the Safety and Efficacy of Almonertinib in Patients With Advanced NSCLC With Rare Mutations in EGFR
This is a multicenter, open, phase II clinical trial evaluating the safety and efficacy of high-dose almonertinib in the treatment of rare mutations in locally advanced or metastatic NSCLC patients with EGFR mutations (excluding exon 19 deletion or rare mutations outside L858R). Patients showed EGFR mutations by tissue or blood tests (excluding exon 19 deletion or rare mutations other than L858R), of which 20 exon (20INS) mutations and rare mutations other than 20Ins were classified as two covariates. High-dose amitinib was used for treatment to evaluate the safety and efficacy of the treatment regimen.
- Conditions
- Safety of Almonertinib
- Being tested
- Almonertinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmonertinibDrug
Almonertinib
| Study group | Role | What they receive |
|---|---|---|
| 20 exon (20INS) mutation | Experimental | Not described Receives: Drug: Almonertinib |
| Rare mutations except for 20INS | Experimental | Not described Receives: Drug: Almonertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
To evaluate the security of high-dose Almonertinib for advanced NSCLC patients with rare mutations in EGFR
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start31 Dec 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety of AlmonertinibStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785742
- Sponsor's protocol ID
- YX-L-202008
- Status last verified
- Mar 2021
- First submitted
- 25 Jan 2021
- Last updated
- 8 Mar 2021
- 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 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter Phase II Clinical Study to Evaluate the Safety and Efficacy of Almonertinib in Patients With Advanced NSCLC With Rare Mutations in EGFR
- ClinicalTrials.gov ID
- NCT04785742
- Acronym / sponsor ID
- YX-L-202008
- Conditions
- Safety of Almonertinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Mar 2021 (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.
This is a multicenter, open, phase II clinical trial evaluating the safety and efficacy of high-dose almonertinib in the treatment of rare mutations in locally advanced or metastatic NSCLC patients with EGFR mutations (excluding exon 19 deletion or rare mutations outside L858R). Patients showed EGFR mutations by tissue or blood tests (excluding exon 19 deletion or rare mutations other than L858R), of which 20 exon (20INS) mutations and rare mutations other than 20Ins were classified as two covariates. High-dose amitinib was used for treatment to evaluate the safety and efficacy of the treatment regimen.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20 exon (20INS) mutation | Experimental | Drug: Almonertinib |
| Rare mutations except for 20INS | Experimental | Drug: Almonertinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. 18 ≤ age ≤75, regardless of gender. 2. Histologically confirmed locally advanced or metastatic non-scaly NSCLC (including stage IIIB-IV patients who relapsed after previous surgical treatment or were newly diagnosed). According to AJCC edition 8 lung cancer staging criteria).
- 3. Previous treatment with second-line chemotherapy (no EGFR-TKI) is allowed. 4. Positive EGFR driver mutation (rare mutation other than 19 exon deletion or L858R) detected by tumor tissue or blood samples.
- 5. The Eastern Tumor Tissue Cooperative Group (ECOG) physical status score was 0 or 1 and did not deteriorate in the previous 2 weeks, with a minimum expected survival of 12 weeks.
- 6. The patient had at least one tumor lesion that had not received previous local treatment such as irradiation, nor had he received biopsy during the screening period, and it could be accurately measured at baseline, with the longest diameter ≥ 10mm at baseline (short diameter ≥ 15mm for lymph nodes). The measurement method chosen is suitable for accurate repeated measurements and can be computed tomography (CT) or magnetic resonance imaging (MRI). If there is only one measurable lesion and no previous local treatment such as irradiation, it may be accepted as the target lesion, and a baseline evaluation of the tumor lesion shall be conducted at least 14 days after the diagnostic biopsy.
- 7. For fertile women, appropriate contraception should be used and breastfeeding should not be performed for 3 months from screening to discontinuation of study treatment. A pregnancy test is negative before administration, or there is no proven risk of pregnancy if one of the following criteria is met:
Key exclusion criteria (28 listed)
- 1. Have received any of the following treatments:
- Patients who underwent major surgery within 4 weeks prior to the first dosing of the study drug;
- Patients who received more than 30% bone marrow irradiation or received large area radiotherapy within 4 weeks prior to the first dosing of the study drug;
- Study drugs that had used a CYP3A4 inhibitor, inducer, or a narrow therapeutic window with a CYP3A4-sensitive substrate within 7 days before first administration.
- 2. Patients with other malignancies requiring standard treatment or major surgery within 2 years of the first dosing of study therapy.
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 |
|---|---|---|
| AlmonertinibAlmonertinib | Drug | 20 exon (20INS) mutation, Rare mutations except for 20INS |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 36 months
To evaluate the security of high-dose Almonertinib for advanced NSCLC patients with rare mutations in EGFR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Almonertinib in people with Safety of Almonertinib, 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 10 inclusion and 28 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 Mar 2021. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 36 months). 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 Mar 2021.