Clinical trial NCT04755738: Almonertinib Plus Microwave Ablation in Advanced Non-small Cell Lung Cancer
Official title: Almonertinib Plus Microwave Ablation Versus Almonertinib in Previously Untreated，Advanced Non-small Cell Lung Cancer, a Randomized，Controlled，Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Non Small Cell Lung Cancer
Keywords: non small cell lung cancer
microwave ablation
epidermal growth factor receptor
progression free survival
overall survival
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
Collaborators: name: Shandong Provincial Hospital
First posted: 2021-02-16
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Pathologically verified non-small-cell lung cancer;
2. Clinical stage of IIIB/IIIC/IV (including postoperative recurrence) ;
3. EGFR Exon 19del or Exon 21 L858R mutations;
4. No previous anti-tumor therapy including chemotherapy, radiotherapy or local thermal ablation (except adjuvant radiotherapy after lung cancer surgery) ;
5. ECOG PS 0-1;
6. Anticipated survival time ≥3 months;
7. 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) ;
8. Asymptomatic brain metastasis;
9. 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).
10. Adequate tissue specimens for further analysis.
11. 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;

Exclusion Criteria:

1. Mixed lung cancer including neuroendocrine or small-cell lung cancer;
2. Multiprimary tumors during the past 5 years;
3. Uncontrolled pleural or pericardial effusion;
4. Patients with a history of interstitial lung disease disease or moderate to severe diffuse dysfunction of the lung;
5. A severe infection (CTCAE \> 2) during the past 4 weeks, such as severe pneumonia, bacteremia, infection complications, etc. requiring hospitalization;
6. baseline chest radiographic examination revealed active pulmonary inflammation.
7. 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;
8. Abnormal coagulation function with bleeding tendency;
9. 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) ;
10. Patients with a history of psychotropic substance abuse who are unable to quit or who have a mental disorder;

Primary outcomes:
measure: PFS
timeFrame: 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:
measure: OS
timeFrame: From the date of randomization to the date of death, assessed up to 36 months.
Other outcomes:
measure: AE
timeFrame: From the date of randomization to the date of disease progression or death，whichever came first, assessed up to 36 months.
Locations:
city: Jinan
country: China
facility: Xin Ye
state: Shandong
Study officials:
References: