EGFR Positive Non-small Cell Lung CancerPhase 2NCT04643847
A Phase II Trial of Upfront Radiotherapy Plus Almonertinib for Epidermal Growth Factor Receptor(EGFR)-Mutant Non-small-cell Lung Cancer(NSCLC) Patients With Brain Metastases
A Phase 2 study testing Almonertinib in people with EGFR Positive Non-small Cell Lung Cancer and Brain Metastases, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
Almonertinib is a three-generation epidermal growth factor receptor tyrosine kinase inhibitor(EGFR-TKI), which has shown competitive potential in the second-line treatment against first-generation TKIs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR Positive Non-small Cell Lung Cancer, Brain Metastases
- What is being tested?
- Almonertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2020to 30 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or pathologically confirmed non-small-cell lung cancer (adenocarcinoma).
- The presence of radiographically definite brain metastases and intracranial foci measurable according to the RANO-BM criteria.
- The number of brain metastases ≤ 10, the volume of individual metastases ≤ 15 cc, the diameter of individual metastases ≤ 30 mm, the diameter of metastases in the brainstem ≤ 5 mm, distance of the foci from the optic nerve, or optic cross > 5 mm.
- EGFR-sensitive mutations (include 19del or L858R mutation or coexist with other types of EGFR mutation).
- Comply with the indications and drug instructions for first-line treatment with a third-generation EGFR-TKI.
- Have not received systemic antineoplastic therapy, excluding neoadjuvant, adjuvant, or synchronous chemotherapy more than 6 months prior to enrollment.
Show all 12Show fewer
- Asymptomatic or mildly symptomatic brain metastases (e.g., headache, nausea, or seizures for which dexamethasone/analgesic/antiepileptic medication is effective and sustained at a steady dose for 3 days or more).
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status(PS) score ≤ 2.
- Survival is expected to be ≥ 6 months.
- Women must use contraception after surgical sterilization, after sterilization, or during and for three months after treatment.
- With informed consent signed.
Who cannot join
- Previous treatment with almonertinib or other EGFR-TKI.
- Patients with symptomatic brain metastases resulting in neurological deficits (not including headaches, nausea, or controlled seizures).
- Multiple sclerosis.
- Pacemakers implanted in the body or metals that cannot be examined by MRI.
- Allergy to magnetic resonance contrast agents.
- Brain metastases requiring surgical decompression.
Show all 16Show fewer
- Meningeal metastases.
- Previous radiotherapy or surgery for brain metastases.
- Contraindications to radiotherapy for uncontrolled systemic lupus erythematosus, scleroderma, or other connective tissue diseases.
- Other malignant neoplasms (except non-melanoma skin cancer and cervical cancer) within five years.
- Any medical or non-medical reason that prevents the patient from continuing to participate in research.
- It is expected that the patient will not be able to comply with the procedures, restrictions, and requirements of the study and the investigator determines that the patient is unfit to participate in the study.
- Received studying drugs within 5 half-lives or 3 months, whichever is greater.
- Currently receiving drugs or herbal supplements known to be potent inducers of Cytochrome P450 3A4(CYP3A4) or unable to be discontinued prior to receiving the first dose of study treatment) (at least 3 weeks prior).
- The patient is taking any drug known to prolong the QT interval and cannot be discontinued until treatment with amitriptyline.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Upfront Radiotherapy Combined With Almonertinib for Brain Metastasis in Non-small Cell Lung Cancer With EGFR Mutation: A Prospective Single-arm Phase II Trial
Almonertinib is a three-generation epidermal growth factor receptor tyrosine kinase inhibitor(EGFR-TKI), which has shown competitive potential in the second-line treatment against first-generation TKIs. This study intends to assess the efficacy and safety of stereotactic radiosurgery with sequential almonertinib in treatment-naive EGFR-mutant NSCLC patients with brain metastases.
- Being tested
- Almonertinib
- Keywords
- NSCLC, EGFR, Brain metastasis
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmonertinibDrug
Also called HS-10296
110mg Almonertinib is administered orally daily since the first day after stereotactic radiosurgery treatment (total dose 30 Gy, 5 fractions, day1, 3, 5, calibrated by CBCT before each treatment). For patients who are assessed as oligometastasis three months after Almonertinib treatment, SBRT is recommended for oligometastatic lesions (The number of lesions received SBRT and radiation dose are not standardized).
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic radiosurgery with Almonertinib | Experimental | 110mg Almonertinib is administered orally daily since the first day after stereotactic radiosurgery treatment (total dose 30 Gy, 5 fractions, day1, 3, 5, calibrated by CBCT before each treatment). For patients who are assessed as oligometastasis three months after Almonertinib treatment, SBRT is recommended for oligometastatic lesions Receives: Drug: Almonertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central nerve system duration of response（CNS DOR）
Central nerve system duration of response assessed by RANO-BM criteria
Measured: 1 year
Secondary outcomes (7)
Intracranial prgression-free survival(PFS)
Intracranial progression free survival assessed by Response Assessment in Neuro-Oncology Brain Metastases(RANO-BM) criteria
Measured: 1 year
Intracranial response rate(RR）
Intracranial response rate assessed by RANO-BM criteria
Measured: 1 year
Extracranial RR
Extracranial response rate assessed by Response Evaluation Criteria in Solid Tumors(RECIST) criteria
Measured: 1 year
overall survival (OS)
overall survival
Measured: 1 year
Neurocognitive function assessed by mini-mental state examination(MMSE) questionnaire score
Neurocognitive function assessed by mini-mental state examination(MMSE) questionnaire score
Measured: 1 year
quality of life(QoL) assessed by EORTC QLQ-C30
Quality of Life assessed by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30(EORTC QLQ-C30)
Measured: 1 year
quality of life(QoL) assessed by EORTC QLQ-BN20
Quality of Life assessed by The European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnaire Brain Cancer 20(BN20)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start30 Nov 2020 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Positive Non-small Cell Lung CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- 110mg Almonertinib is administered orally daily since the first day after stereotactic radiosurgery treatment (total dose 30 Gy, 5 fractions, day1, 3, 5, calibrated by cone beam computed tomography(CBCT) before each treatment). For patients who are assessed as oligometastasis three month after Almonertinib treatment, stereotactic body radiation therapy(SBRT) is recommended for oligometastatic lesions.
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643847
- Sponsor's protocol ID
- AlmonRad
- Status last verified
- Nov 2020
- First submitted
- 15 Nov 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- 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 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upfront Radiotherapy Combined With Almonertinib for Brain Metastasis in Non-small Cell Lung Cancer With EGFR Mutation: A Prospective Single-arm Phase II Trial
- ClinicalTrials.gov ID
- NCT04643847
- Acronym / sponsor ID
- AlmonRad
- Keywords
- NSCLC, EGFR, Brain metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 30 Nov 2020 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 25 Nov 2020 (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.
Almonertinib is a three-generation epidermal growth factor receptor tyrosine kinase inhibitor(EGFR-TKI), which has shown competitive potential in the second-line treatment against first-generation TKIs. This study intends to assess the efficacy and safety of stereotactic radiosurgery with sequential almonertinib in treatment-naive EGFR-mutant NSCLC patients with brain metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 110mg Almonertinib is administered orally daily since the first day after stereotactic radiosurgery treatment (total dose 30 Gy, 5 fractions, day1, 3, 5, calibrated by cone beam computed tomography(CBCT) before each treatment). For patients who are assessed as oligometastasis three month after Almonertinib treatment, stereotactic body radiation therapy(SBRT) is recommended for oligometastatic lesions.
| Arm | Type | Receives |
|---|---|---|
| Stereotactic radiosurgery with Almonertinib | Experimental | Drug: Almonertinib110mg Almonertinib is administered orally daily since the first day after stereotactic radiosurgery treatment (total dose 30 Gy, 5 fractions, day1, 3, 5, calibrated by CBCT before each treatment). For patients who are assessed as oligometastasis three months after Almonertinib treatment, SBRT is recommended for oligometastatic lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically or pathologically confirmed non-small-cell lung cancer (adenocarcinoma).
- The presence of radiographically definite brain metastases and intracranial foci measurable according to the RANO-BM criteria.
- The number of brain metastases ≤ 10, the volume of individual metastases ≤ 15 cc, the diameter of individual metastases ≤ 30 mm, the diameter of metastases in the brainstem ≤ 5 mm, distance of the foci from the optic nerve, or optic cross > 5 mm.
- EGFR-sensitive mutations (include 19del or L858R mutation or coexist with other types of EGFR mutation).
- Comply with the indications and drug instructions for first-line treatment with a third-generation EGFR-TKI.
Key exclusion criteria (16 listed)
- Previous treatment with almonertinib or other EGFR-TKI.
- Patients with symptomatic brain metastases resulting in neurological deficits (not including headaches, nausea, or controlled seizures).
- Multiple sclerosis.
- Pacemakers implanted in the body or metals that cannot be examined by MRI.
- Allergy to magnetic resonance contrast agents.
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 |
|---|---|---|
| AlmonertinibAlso: HS-10296110mg Almonertinib is administered orally daily since the first day after stereotactic radiosurgery treatment (total dose 30 Gy, 5 fractions, day1, 3, 5, calibrated by CBCT before each treatment). For patients who are assessed as oligometastasis three months after Almonertinib treatment, SBRT is recommended for oligometastatic lesions (The number of lesions received SBRT and radiation dose are not standardized). | Drug | Stereotactic radiosurgery with Almonertinib |
Primary outcome
Central nerve system duration of response（CNS DOR）
Time frame: 1 year
Central nerve system duration of response assessed by RANO-BM criteria
7 secondary outcomes
Intracranial prgression-free survival(PFS)
Time frame: 1 year
Intracranial response rate(RR）
Time frame: 1 year
Extracranial RR
Time frame: 1 year
overall survival (OS)
Time frame: 1 year
Neurocognitive function assessed by mini-mental state examination(MMSE) questionnaire score
Time frame: 1 year
quality of life(QoL) assessed by EORTC QLQ-C30
Time frame: 1 year
quality of life(QoL) assessed by EORTC QLQ-BN20
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for EGFR Positive Non-small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruitingPhase 1
Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC
EGFR-mutant Non-small Cell Lung Cancer
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
Active, not recruitingPhase 2
Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib
Carcinoma
Not yet recruitingPhase 4
A Clinical Study Comparing the Efficacy and Safety of Befotertinib Versus Icotinib in Patients With Previously Untreated EGFR-sensitive Mutation-positive Non-small Cell Lung Cancer With ECOG Score ≥2
Locally Advanced or Metastatic Non-small Cell Lung Cancer With Previously Untreated EGFR-sensitive Mutations and ECOG Performance Status Score ≥2
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.
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 EGFR Positive Non-small Cell Lung Cancer and Brain Metastases, run by First People's Hospital of Hangzhou 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 12 inclusion and 16 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 25 Nov 2020. 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 Bing Xia, MD (86 571 56006388, bxia_hzch@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central nerve system duration of response（CNS DOR） (time frame: 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 25 Nov 2020.