Non-small Cell Lung CancerNCT06481566
Efficacy and Safety of Almonertinib Combined With Stereotactic Body Radiotherapy (SBRT) in the Treatment of Non-small Cell Lung Cancer With EGFR Sensitive Mutation: a Single-arm, Open-label Clinical Trial
A study testing stereotactic ablative body radiotherapy in people with Non-small Cell Lung Cancer, run by Chongqing University Cancer Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if first-line Almonertinib plus upfront stereotactic ablative body radiotherapy (SABR) works to treat EGFR-mutated advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- stereotactic ablative body radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2024to 30 Jun 2026
- Phase
- Interventional
- 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
- Aged 18 years or older (including 18 years) and less than 75 years (including 75 years).
- Subjects with histologically or cytologically confirmed unresectable NSCLC and stage IIIB-IV tumours (as determined by the International Association for the Study of Lung Cancer (IASLC) Manual of Thoracic Tumour Staging, 8th edition). Oligometastatic lesions (≤5) in the brain on head-enhanced MRI were eligible for enrolment, and at least 1 lesion in the brain could be accurately measured at baseline, with the longest diameter at baseline ≥5 mm. Measurements were made by MRI (layer thickness 1.5 mm).
- Have not received any systemic therapy after diagnosis of NSCLC or have not progressed with 1-2 cycles of chemotherapy.
- Tumour tissue samples or blood samples diagnosed with NSCLC are tested and confirmed to have an EGFR-sensitive mutation (including exon 19 deletion or L858R, either alone or coexisting with mutations in other EGFR loci). Tumour tissue is recommended if the tumour tissue is accessible; if the tumour tissue is inaccessible or the patient is not amenable to tissue biopsy, blood samples will be sent to test EGFR mutation.
- Patients with an Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1 and no deterioration in the previous 2 weeks, with a minimum expected survival of 12 weeks.
- At least 1 tumour lesion in the patient's lungs can be accurately measured at baseline with a longest diameter of ≥10 mm at baseline (in the case of lymph nodes, a short diameter of ≥15 mm is required). The measurement method of choice is suitable for accurate repeat measurements, either computed tomography (CT) or magnetic resonance imaging (MRI). Only 1 measurable lesion is accepted as a target lesion if it is present, subject to baseline evaluation of the tumour lesion at least 14 days after diagnostic biopsy. And the primary residual lung lesion is suitable for SBRT after targeted therapy.
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- Women of childbearing potential are required to use adequate contraception and should not be breastfeeding from screening until 3 months after discontinuation of study treatment. Negative pregnancy test prior to initiation of dosing or no risk of pregnancy as evidenced by meeting one of the following criteria:
- Postmenopausal defined as amenorrhoea for at least 12 months after age greater than 50 years and cessation of all exogenous hormone replacement therapy;
- Women younger than 50 years of age may also be considered postmenopausal if they have had amenorrhoea for 12 months or more after cessation of all exogenous hormone therapy and have luteinising hormone (LH) and follicle-stimulating hormone (FSH) levels in the range of laboratory postmenopausal reference values.
- Previous irreversible sterilisation including hysterectomy, bilateral oophorectomy or bilateral salpingo-oophorectomy, with the exception of bilateral tubal ligation.
- Barrier contraception (i.e., condoms) should be used by male patients from screening until 3 months after discontinuation of study treatment.
- Subjects participate voluntarily and sign a written informed consent form.
Who cannot join
- Subjects will not be enrolled in the study if they fulfil any of the following criteria:
- Patients with postoperative recurrence.
- Non-primary patients who have received any of the following prior treatments:
- prior use of any EGFR tyrosine kinase inhibitor (EGFR-TKI);
- prior radiotherapy for any lung cancer;
- patient has undergone major surgery within 4 weeks prior to the first dose of study drug;
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- use of a strong inhibitor of CYP3A4, an inducer, or a drug with a narrow therapeutic window that is a CYP3A4-sensitive substrate within 7 days prior to the first dose of study drug.
- Patients with other malignancies that require standardised treatment or major surgery within 2 years of the first dose of study treatment.
- Patients who are amenable to surgical resection.
- Patients with progression within 3 months of targeted therapy.
- Patients with unrelieved residual toxicity from prior therapy greater than CTCAE grade 1 at the time of initiation of study treatment, with the exception of alopecia and grade 2 neurotoxicity from prior chemotherapy.
- Patients with uncontrolled pleural effusion and/or pericardial effusion.
- Have any serious or poorly controlled systemic disease such as poorly controlled hypertension, active bleeding prone constitution or active infection as judged by the investigator. Exclusion of chronic diseases is not required.
- Refractory nausea, vomiting or chronic gastrointestinal disorders, inability to swallow study medication or a history of extensive bowel resection that may interfere with adequate absorption of almonertinib.
- Cardiac findings consistent with any of the following:
- resting electrocardiogram (ECG) examination yielding a corrected QT interval (QTc) > 470 msec, applying the Fridericia formula for QT interval correction (QTcF);
- resting ECG suggests the presence of a variety of clinically significant rhythmic, conduction, or ECG morphological abnormalities (e.g., complete left bundle-branch block, third-degree atrioventricular conduction).
- presence of any factor that increases the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome, or sudden unexplained death in an immediate family member under the age of 40 years or any combination of medications that prolong the QT interval;
- left ventricular ejection fraction (LVEF) ≤40%.
- History of interstitial lung disease or any evidence of clinically active interstitial lung disease.
- Inadequate bone marrow reserve or organ function at the following laboratory limits:
- Absolute neutrophil count < 1.5 x 10^9 / L;
- Platelet count < 100 x 10^9 / L;
- Haemoglobin < 90 g/L (< 9 g/dL);
- Alanine aminotransferase > 2.5 times the upper limit of normal (ULN);
- Aspartate aminotransferase > 2.5 x ULN;
- Total bilirubin > 1.5 x ULN; or presence of Gilbert's syndrome (unconjugated hyperbilirubinemia);
- Creatinine > 1.5 x ULN and creatinine clearance < 50 mL/min (calculated by the Cockcroft - Gault formula); confirmation of creatinine clearance is required only if creatinine > 1.5 x ULN.
- Women who are breastfeeding or who have had a positive blood or urine pregnancy test result within 3 days prior to the first dose of study treatment.
- History of hypersensitivity to any active or inactive ingredient of almonertinib or to a drug with a similar chemical structure to almonertinib or an analogue of almonertinib.
- Any serious or uncontrolled ocular pathology that, in the judgement of the physician, may increase the risk to the patient's safety.
- Patients who, in the judgement of the investigator, may have poor compliance with the procedures and requirements of the study.
- Patients who, in the judgement of the investigator, have any condition that jeopardises patient safety or interferes with the assessment of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Dan Tao, Dr., +86-15826186392, taodan@cqu.edu.cn
About this study
The goal of this clinical trial is to learn if first-line Almonertinib plus upfront stereotactic ablative body radiotherapy (SABR) works to treat EGFR-mutated advanced non-small cell lung cancer. The main questions it aims to answer are:
Does first-line Almonertinib plus upfront stereotactic ablative body radiotherapy to residual primary lung lesions prolong the progression-free survival of EGFR-mutated advanced non-small cell lung cancer.
Read more
Participants will:
Take first-line Almonertinib for 2-4 months, then deliver SABR to residual primary lung lesions, after that go on Almonertinib maintenance treatment； Visit the hospital once every 3 months for checkups and tests； Keep a diary of their symptoms ；
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- stereotactic ablative body radiotherapy
- Keywords
- Non-small cell lung cancer, Stereotactic Ablative Body Radiotherapy, EGFR-TKI
- 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.
stereotactic ablative body radiotherapyRadiation
The residual primary lung lesions after first-line Almonertinib will be delivered stereotactic ablative body radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Almonertinib plus SABR group | Experimental | Take first-line Almonertinib for 2-4 months, then deliver SABR to residual primary lung lesions; after that, go on Almonertinib maintenance treatment Receives: Radiation: stereotactic ablative body radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS was defined from the date of starting Almonertinib treatment to the date of disease progression or death from any cause.
Measured: Time Frame: 18 months
Secondary outcomes (1)
OS
OS was defined from the date of starting Almonertinib treatment to the date of death or last follow-up.
Measured: Time Frame: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start21 Jun 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Almonertinib Combined With Upfront Stereotactic Ablative Body Radiotherapy for Residual Primary Lung Lesions
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhou, Chongqing University Cancer Hospital
- Investigators
- Wei Zhou, Dr., Principal investigator, Chongqing University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481566
- Sponsor's protocol ID
- AlmoSABR
- Status last verified
- Aug 2024
- First submitted
- 20 Jun 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel SH, Rimner A, Foster A, Zhang Z, Woo KM, Yu HA, Riely GJ, Wu AJ. Patterns of initial and intracranial failure in metastatic EGFR-mutant non-small cell lung cancer treated with erlotinib. Lung Cancer. 2017 Jun;108:109-114. doi: 10.1016/j.lungcan.2017.03.010. Epub 2017 Mar 24.
PubMed 28625621Al-Halabi H, Sayegh K, Digamurthy SR, Niemierko A, Piotrowska Z, Willers H, Sequist LV. Pattern of Failure Analysis in Metastatic EGFR-Mutant Lung Cancer Treated with Tyrosine Kinase Inhibitors to Identify Candidates for Consolidation Stereotactic Body Radiation Therapy. J Thorac Oncol. 2015 Nov;10(11):1601-7. doi: 10.1097/JTO.0000000000000648.
PubMed 26313684Guo T, Ni J, Yang X, Li Y, Li Y, Zou L, Wang S, Liu Q, Chu L, Chu X, Li S, Ye L, Zhu Z. Pattern of Recurrence Analysis in Metastatic EGFR-Mutant NSCLC Treated with Osimertinib: Implications for Consolidative Stereotactic Body Radiation Therapy. Int J Radiat Oncol Biol Phys. 2020 May 1;107(1):62-71. doi: 10.1016/j.ijrobp.2019.12.042. Epub 2020 Jan 25.
PubMed 31987959Wang XS, Bai YF, Verma V, Yu RL, Tian W, Ao R, Deng Y, Zhu XQ, Liu H, Pan HX, Yang L, Bai HS, Luo X, Guo Y, Zhou MX, Sun YM, Zhang ZC, Li SM, Cheng X, Tan BX, Han LF, Liu YY, Zhang K, Zeng FX, Jia L, Hao XB, Wang YY, Feng G, Xie K, Lu Y, Zeng M. Randomized Trial of First-Line Tyrosine Kinase Inhibitor With or Without Radiotherapy for Synchronous Oligometastatic EGFR-Mutated Non-Small Cell Lung Cancer. J Natl Cancer Inst. 2023 Jun 8;115(6):742-748. doi: 10.1093/jnci/djac015.
PubMed 35094066Tsai CJ, Yang JT, Shaverdian N, Patel J, Shepherd AF, Eng J, Guttmann D, Yeh R, Gelblum DY, Namakydoust A, Preeshagul I, Modi S, Seidman A, Traina T, Drullinsky P, Flynn J, Zhang Z, Rimner A, Gillespie EF, Gomez DR, Lee NY, Berger M, Robson ME, Reis-Filho JS, Riaz N, Rudin CM, Powell SN; CURB Study Group. Standard-of-care systemic therapy with or without stereotactic body radiotherapy in patients with oligoprogressive breast cancer or non-small-cell lung cancer (Consolidative Use of Radiotherapy to Block [CURB] oligoprogression): an open-label, randomised, controlled, phase 2 study. Lancet. 2024 Jan 13;403(10422):171-182. doi: 10.1016/S0140-6736(23)01857-3. Epub 2023 Dec 14.
PubMed 38104577
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Almonertinib Combined With Stereotactic Body Radiotherapy (SBRT) in the Treatment of Non-small Cell Lung Cancer With EGFR Sensitive Mutation: a Single-arm, Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT06481566
- Acronym / sponsor ID
- AlmoSABR
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer, Stereotactic Ablative Body Radiotherapy, EGFR-TKI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 Jul 2024 (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.
The goal of this clinical trial is to learn if first-line Almonertinib plus upfront stereotactic ablative body radiotherapy (SABR) works to treat EGFR-mutated advanced non-small cell lung cancer. The main questions it aims to answer are:
Does first-line Almonertinib plus upfront stereotactic ablative body radiotherapy to residual primary lung lesions prolong the progression-free survival of EGFR-mutated advanced non-small cell lung cancer.
Participants will:
Take first-line Almonertinib for 2-4 months, then deliver SABR to residual primary lung lesions, after that go on Almonertinib maintenance treatment； Visit the hospital once every 3 months for checkups and tests； Keep a diary of their symptoms ；
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Almonertinib Combined With Upfront Stereotactic Ablative Body Radiotherapy for Residual Primary Lung Lesions
| Arm | Type | Receives |
|---|---|---|
| Almonertinib plus SABR group | Experimental | Radiation: stereotactic ablative body radiotherapyTake first-line Almonertinib for 2-4 months, then deliver SABR to residual primary lung lesions; after that, go on Almonertinib maintenance treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aged 18 years or older (including 18 years) and less than 75 years (including 75 years).
- Subjects with histologically or cytologically confirmed unresectable NSCLC and stage IIIB-IV tumours (as determined by the International Association for the Study of Lung Cancer (IASLC) Manual of Thoracic Tumour Staging, 8th edition). Oligometastatic lesions (≤5) in the brain on head-enhanced MRI were eligible for enrolment, and at least 1 lesion in the brain could be accurately measured at baseline, with the longest diameter at baseline ≥5 mm. Measurements were made by MRI (layer thickness 1.5 mm).
- Have not received any systemic therapy after diagnosis of NSCLC or have not progressed with 1-2 cycles of chemotherapy.
- Tumour tissue samples or blood samples diagnosed with NSCLC are tested and confirmed to have an EGFR-sensitive mutation (including exon 19 deletion or L858R, either alone or coexisting with mutations in other EGFR loci). Tumour tissue is recommended if the tumour tissue is accessible; if the tumour tissue is inaccessible or the patient is not amenable to tissue biopsy, blood samples will be sent to test EGFR mutation.
- Patients with an Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1 and no deterioration in the previous 2 weeks, with a minimum expected survival of 12 weeks.
Key exclusion criteria (33 listed)
- Patients with postoperative recurrence.
- Non-primary patients who have received any of the following prior treatments:
- Patients with other malignancies that require standardised treatment or major surgery within 2 years of the first dose of study treatment.
- Patients who are amenable to surgical resection.
- Patients with progression within 3 months of targeted 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 |
|---|---|---|
| stereotactic ablative body radiotherapyThe residual primary lung lesions after first-line Almonertinib will be delivered stereotactic ablative body radiotherapy. | Radiation | Almonertinib plus SABR group |
Primary outcome
PFS
Time frame: Time Frame: 18 months
PFS was defined from the date of starting Almonertinib treatment to the date of disease progression or death from any cause.
1 secondary outcome
OS
Time frame: Time Frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Background: PubMed 28625621Patel SH, Rimner A, Foster A, Zhang Z, Woo KM, Yu HA, Riely GJ, Wu AJ. Patterns of initial and intracranial failure in metastatic EGFR-mutant non-small cell lung cancer treated with erlotinib. Lung Cancer. 2017 Jun;108:109-114. doi: 10.1016/j.lungcan.2017.03.010. Epub 2017 Mar 24.
- Background: PubMed 26313684Al-Halabi H, Sayegh K, Digamurthy SR, Niemierko A, Piotrowska Z, Willers H, Sequist LV. Pattern of Failure Analysis in Metastatic EGFR-Mutant Lung Cancer Treated with Tyrosine Kinase Inhibitors to Identify Candidates for Consolidation Stereotactic Body Radiation Therapy. J Thorac Oncol. 2015 Nov;10(11):1601-7. doi: 10.1097/JTO.0000000000000648.
- Background: PubMed 31987959Guo T, Ni J, Yang X, Li Y, Li Y, Zou L, Wang S, Liu Q, Chu L, Chu X, Li S, Ye L, Zhu Z. Pattern of Recurrence Analysis in Metastatic EGFR-Mutant NSCLC Treated with Osimertinib: Implications for Consolidative Stereotactic Body Radiation Therapy. Int J Radiat Oncol Biol Phys. 2020 May 1;107(1):62-71. doi: 10.1016/j.ijrobp.2019.12.042. Epub 2020 Jan 25.
- Background: PubMed 35094066Wang XS, Bai YF, Verma V, Yu RL, Tian W, Ao R, Deng Y, Zhu XQ, Liu H, Pan HX, Yang L, Bai HS, Luo X, Guo Y, Zhou MX, Sun YM, Zhang ZC, Li SM, Cheng X, Tan BX, Han LF, Liu YY, Zhang K, Zeng FX, Jia L, Hao XB, Wang YY, Feng G, Xie K, Lu Y, Zeng M. Randomized Trial of First-Line Tyrosine Kinase Inhibitor With or Without Radiotherapy for Synchronous Oligometastatic EGFR-Mutated Non-Small Cell Lung Cancer. J Natl Cancer Inst. 2023 Jun 8;115(6):742-748. doi: 10.1093/jnci/djac015.
- Background: PubMed 38104577Tsai CJ, Yang JT, Shaverdian N, Patel J, Shepherd AF, Eng J, Guttmann D, Yeh R, Gelblum DY, Namakydoust A, Preeshagul I, Modi S, Seidman A, Traina T, Drullinsky P, Flynn J, Zhang Z, Rimner A, Gillespie EF, Gomez DR, Lee NY, Berger M, Robson ME, Reis-Filho JS, Riaz N, Rudin CM, Powell SN; CURB Study Group. Standard-of-care systemic therapy with or without stereotactic body radiotherapy in patients with oligoprogressive breast cancer or non-small-cell lung cancer (Consolidative Use of Radiotherapy to Block [CURB] oligoprogression): an open-label, randomised, controlled, phase 2 study. Lancet. 2024 Jan 13;403(10422):171-182. doi: 10.1016/S0140-6736(23)01857-3. Epub 2023 Dec 14.
- 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.
Wei Zhou, Dr. principal investigator
Chongqing University Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stereotactic ablative body radiotherapy in people with Non-small Cell Lung Cancer, run by Chongqing University Cancer Hospital 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 33 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 4 Sep 2024. 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.
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 Dan Tao, Dr. (+86-15826186392, taodan@cqu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Time Frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06481566, which also lists 5 linked publications.
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 4 Sep 2024.