Advanced Non Small Cell Lung CancerPhase 2MWANCT04755738
Almonertinib Plus Microwave Ablation in Advanced Non-small Cell Lung Cancer
A Phase 2 study testing Almonertinib plus microwave ablation in people with Advanced Non Small Cell Lung Cancer, run by Qianfoshan Hospital at 1 site in China.
Trial summary
Almonertinib, as a third-generation EGFR-TKI, has been used for the treatment of advanced non small cell lung cancer. How to improve the progression free survival in advance was a challenge. Our previous study showed that first-line EGFR-TKIs plus microwave ablation had PFS survival advantage versus EGFR-TKIs alone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Non Small Cell Lung Cancer
- What is being tested?
- Almonertinib plus microwave ablation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Mar 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically verified non-small-cell lung cancer;
- Clinical stage of IIIB/IIIC/IV (including postoperative recurrence) ;
- EGFR Exon 19del or Exon 21 L858R mutations;
- No previous anti-tumor therapy including chemotherapy, radiotherapy or local thermal ablation (except adjuvant radiotherapy after lung cancer surgery) ;
- ECOG PS 0-1;
- Anticipated survival time ≥3 months;
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- At least one measurable lesions (according to RECIST 1.1, CT scan length ≥10mm, CT scan short diameter ≥15mm) except the ablation lesions (primary lesion or the largest recurrent lesion) ;
- Asymptomatic brain metastasis;
- The routine laboratory examination was normal (blood routine, liver and kidney function, blood coagulation function, etc The standard of blood routine examination should be met (No blood transfusion and blood products within 14 days) ; ANC≥1.5×109/L; PLT ≥80×109/L. B. Biochemical examination should meet the following criteria: TBIL≤ 1.5 ULN; ALT, Ast ≤ 2.5 ULN).
- Adequate tissue specimens for further analysis.
- Patients with potential fertility need to use a medically approved contraceptive method (such as intrauterine device, birth control pills or condoms) during and within 1 month after the end of the study period; The serum or urine HCG test must be negative within 72 hours before admission to the study, and must be non-lactation period; (12)18-80 years old;
- (13)Patients signed informed consent;
Who cannot join
- Mixed lung cancer including neuroendocrine or small-cell lung cancer;
- Multiprimary tumors during the past 5 years;
- Uncontrolled pleural or pericardial effusion;
- Patients with a history of interstitial lung disease disease or moderate to severe diffuse dysfunction of the lung;
- A severe infection (CTCAE > 2) during the past 4 weeks, such as severe pneumonia, bacteremia, infection complications, etc. requiring hospitalization;
- baseline chest radiographic examination revealed active pulmonary inflammation.
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- The patients experienced acute cardiac cerebrovascular disease such as acute cerebral infarction and acute coronary syndrome within 1 month, (8) The cardiovascular clinical symptoms or diseases were not well controlled, including the following cases: There is local active Ulcer Focus, and stool occult blood {(+ +) can not be included in the group } ; within 2 months, there are black stool, hematemesis history;
- Abnormal coagulation function with bleeding tendency;
- Congenital or acquired immune deficiency (such as HIV infection) or active hepatitis (Hepatitis B reference: HBV DNA test above the normal limit; Hepatitis C reference: HCV virus or RNA test above the normal limit) ;
- Patients with a history of psychotropic substance abuse who are unable to quit or who have a mental disorder;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Almonertinib Plus Microwave Ablation Versus Almonertinib in Previously Untreated，Advanced Non-small Cell Lung Cancer, a Randomized，Controlled，Phase II Clinical Trial
Almonertinib, as a third-generation EGFR-TKI, has been used for the treatment of advanced non small cell lung cancer. How to improve the progression free survival in advance was a challenge. Our previous study showed that first-line EGFR-TKIs plus microwave ablation had PFS survival advantage versus EGFR-TKIs alone. So we conducted this prospective study to verify the efficacy and safety of the combination in a randomized, controlled, phase II clinical trial.
Read the detailed description
Almonertinib, as a third-generation EGFR-TKI, has been used for the treatment of advanced non small cell lung cancer. How to improve the progression free survival in advance was a challenge. Our previous study showed that first-line EGFR-TKIs plus microwave ablation had PFS survival advantage versus EGFR-TKIs alone. So we conducted this prospective study to verify the efficacy and safety of the combination in a randomized, controlled, phase II clinical trial. Patients were assigned into two groups.In the experiment group, patients were treated with both Almonertinib and microwave ablation. In the control group, patients were treated with Almonertinib alone. The primary end point was progression free survival. Second endpoints included overall survival and safety.
- Conditions
- Advanced Non Small Cell Lung Cancer
- Being tested
- Almonertinib plus microwave ablation
- Keywords
- non small cell lung cancer, microwave ablation, epidermal growth factor receptor, progression free survival, overall survival
- 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.
Almonertinib plus microwave ablationCombination product
Also called Microwave ablation
Patients were treated with almonertinib firstly.When almonertinib achieved the maximal response, microwave ablation was conducted on the primary lung tumors.
| Study group | Role | What they receive |
|---|---|---|
| Almonertinib plus Microwave ablation group | Experimental | Patients in the group were treated with both targeted therapy and microwave ablation. Patients were treated with Almonertinib with the dose of 110mg once daily firstly. When the best response achieved, microwave ablation was conducted in the primary tumors, and then followed by Almonertinib treatments. Receives: Combination Product: Almonertinib plus microwave ablation |
| Almonertinib group | Active comparator | Patients in the group were treated with Almonertinib with the dose of 110mg once daily until disease progression, death or intolerable adverse events. Receives: Combination Product: Almonertinib plus microwave ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression free survival
Measured: From the date of randomization to the date of disease progression or death for any causes，whichever came first, assessed up to 36 months.
Secondary outcomes (1)
OS
overall survival
Measured: From the date of randomization to the date of death, assessed up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start1 Jan 2022 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital
- Responsible party
- Principal investigator, Lili Cao, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755738
- Sponsor's protocol ID
- QianfoshanH O
- Acronym
- MWA
- Status last verified
- Sep 2021
- First submitted
- 7 Feb 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It depends.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Almonertinib Plus Microwave Ablation Versus Almonertinib in Previously Untreated，Advanced Non-small Cell Lung Cancer, a Randomized，Controlled，Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT04755738
- Acronym / sponsor ID
- MWA / QianfoshanH O
- Conditions
- Advanced Non Small Cell Lung Cancer
- Keywords
- non small cell lung cancer, microwave ablation, epidermal growth factor receptor, progression free survival, overall survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 16 Feb 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.
Almonertinib, as a third-generation EGFR-TKI, has been used for the treatment of advanced non small cell lung cancer. How to improve the progression free survival in advance was a challenge. Our previous study showed that first-line EGFR-TKIs plus microwave ablation had PFS survival advantage versus EGFR-TKIs alone. So we conducted this prospective study to verify the efficacy and safety of the combination in a randomized, controlled, phase II clinical trial.
Detailed description
Almonertinib, as a third-generation EGFR-TKI, has been used for the treatment of advanced non small cell lung cancer. How to improve the progression free survival in advance was a challenge. Our previous study showed that first-line EGFR-TKIs plus microwave ablation had PFS survival advantage versus EGFR-TKIs alone. So we conducted this prospective study to verify the efficacy and safety of the combination in a randomized, controlled, phase II clinical trial. Patients were assigned into two groups.In the experiment group, patients were treated with both Almonertinib and microwave ablation. In the control group, patients were treated with Almonertinib alone. The primary end point was progression free survival. Second endpoints included overall survival and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almonertinib plus Microwave ablation group | Experimental | Combination Product: Almonertinib plus microwave ablationPatients in the group were treated with both targeted therapy and microwave ablation. Patients were treated with Almonertinib with the dose of 110mg once daily firstly. When the best response achieved, microwave ablation was conducted in the primary tumors, and then followed by Almonertinib treatments. |
| Almonertinib group | Active comparator | Combination Product: Almonertinib plus microwave ablationPatients in the group were treated with Almonertinib with the dose of 110mg once daily until disease progression, death or intolerable adverse events. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Pathologically verified non-small-cell lung cancer;
- Clinical stage of IIIB/IIIC/IV (including postoperative recurrence) ;
- EGFR Exon 19del or Exon 21 L858R mutations;
- No previous anti-tumor therapy including chemotherapy, radiotherapy or local thermal ablation (except adjuvant radiotherapy after lung cancer surgery) ;
- ECOG PS 0-1;
Key exclusion criteria (10 listed)
- Mixed lung cancer including neuroendocrine or small-cell lung cancer;
- Multiprimary tumors during the past 5 years;
- Uncontrolled pleural or pericardial effusion;
- Patients with a history of interstitial lung disease disease or moderate to severe diffuse dysfunction of the lung;
- A severe infection (CTCAE > 2) during the past 4 weeks, such as severe pneumonia, bacteremia, infection complications, etc. requiring hospitalization;
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 |
|---|---|---|
| Almonertinib plus microwave ablationAlso: Microwave ablationPatients were treated with almonertinib firstly.When almonertinib achieved the maximal response, microwave ablation was conducted on the primary lung tumors. | Combination product | Almonertinib group, Almonertinib plus Microwave ablation group |
Primary outcome
PFS
Time frame: From the date of randomization to the date of disease progression or death for any causes，whichever came first, assessed up to 36 months.
progression free survival
1 secondary outcome
OS
Time frame: From the date of randomization to the date of death, assessed up to 36 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: No. It depends.
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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.
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 plus microwave ablation in people with Advanced Non Small Cell Lung Cancer, run by Qianfoshan 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 10 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 5 Sep 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?
Contact Xin Ye (+86 53189268553 ext. 1, yexintaian2020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From the date of randomization to the date of disease progression or death for any causes，whichever came first, assessed up to 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 5 Sep 2021.