Advanced Non-small Cell Lung CancerPhase 3NCT06043973
Almonertinib Combined With Anlotinib as First-line Treatment for Advanced Non-small Cell Lung Cance
A Phase 3 study testing almonertinib in people with Advanced Non-small Cell Lung Cancer, run by Qianfoshan Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of almonertinib plus anlotinib as first-line treatment for advanced non-small cell lung cancer with EGFR sensitive mutation and TP53 mutation. This study is an exploratory single-arm study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer
- What is being tested?
- almonertinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 30 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Metastatic Non-squamous NSCLC is histologically or cytologically proven to be inoperable and cannot receive radical concurrent chemoradiotherapy. The conventional TNM stage was identified as stage IIIa-Ⅳb according to the International Association for the Study of Lung Cancer and the American Joint Committee on the Classification of Cancer 8th edition TNM Staging of Lung Cancer.
- Patients with EGFR mutation and TP53 mutation advanced Non-squamous NSCLC. Patients who had not previously received systemic radiotherapy and chemotherapy or who had relapsed for more than 6 months of follow-up after onset of adjuvant chemotherapy.
- At least one measurable lesion as determined by RECIST criteria. Male or female patients, age: 18-75 years of age. Performance score 0-1 based on Eastern Cooperative Oncology Group (ECOG) test. Expected survival period ≥12 weeks. Serum absolute number of neutrophils≥ 1.5 x 10^9/L, platelet ≥ 100 x10^9/L, and hemoglobin≥ 90g/L.
- Serum bilirubin≤1.5 times ULNL, aspartate aminotransferase (AST) and adenosine triphosphate(ALT) ≤ 2.5 times ULN, alkaline phosphatase ≤ 5 times ULN.
- Serum creatinine≤ the ULN or creatinine clearance ≥ 60 mL/min. Patients who had previously undergone surgery have recovered for more than 4 weeks from the beginning of the project.
- Women with an intact uterus must have a negative pregnancy test within 28 days prior to enrolement in the study (unless it was 24 months after amenorrhea). If the pregnancy test is more than 7 days prior to initial dosing, a urine pregnancy test is required for verification (within 7 days prior to initial dosing).
- If there is a risk of conception, all patients (whether male or female) are required to use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of the study drug.
- Sign the inform consent form with good compliance.
Who cannot join
- Those who are known to be allergic to the study drug almonertinib and anlotinib and its any components.
- Intolerance to study drug treatment or allergy to the active ingredients or excipients of combined chemotherapy drugs.
- Pregnancy or breastfeeding women or women who may be pregnant but are unwilling to take appropriate contraception.
- Existing severe acute infections that are not under control; Or suppurative and chronic infections with delayed healing.
- Pre-existing serious heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina pectoris, myocardial infarction, severe valvular heart disease, and refractory hypertension.
- People suffering from uncontrollable neuropsychiatric diseases or mental disorders had poor compliance and were unable to cooperate and describe treatment responses; The conditions of patients with primary brain tumor or central nerve metastatic tumor were uncontrollable and the symptoms of cranial hypertension or neuropsychiatric were obvious.
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- Patients with hereditary bleeding tendency or coagulation dysfunction, or history of thrombosis or bleeding, and abnormal detection results of coagulation function related indicators.
- Patients who are receiving thrombolytic or anticoagulant therapy due to high risk of thrombosis.
- Patients with unhealed wounds, unhealed ulcers or unhealed fractures. Other conditions that the investigator considers to be inappropriate for the patient to participate in this trial.
- Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose.
- Patients who have undergone major surgery within 4 weeks before the start of study treatment or are scheduled to undergo major surgery during the study period (except for surgery such as puncture or lymph node biopsy).
- Pulmonary interstitial fibrosis with respiratory failure. Chronic obstructive pulmonary disease with respiratory failure. Active pulmonary tuberculosis; Active autoimmune disease requiring systemic therapy (such as the use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (such as thyroxine) is not considered systemic therapy; Those who are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 14 days before the first dose of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Degan Lu
Jinan, Shandong, 250014
Degan Lu, professor, 18753157623, deganlu@126.com
About this study
Official title: A Prospective Single-center, Single-arm Clinical Study of Almonertinib Combined With Anlotinib as First-line Treatment for Advanced Non-small Cell Lung Cancer With EGFR Sensitive Mutation and TP53 Mutation
To evaluate the efficacy and safety of almonertinib plus anlotinib as first-line treatment for advanced non-small cell lung cancer with EGFR sensitive mutation and TP53 mutation.
This study is an exploratory single-arm study. The specific treatment regimen is as follows: Non-squamous NSCLC: almonertinib (110 mg/d) plus anlotinib (12mg/d) is started on the first day of each treatment cycle and administered every three weeks until disease progression or intolerable toxicity. Anlotinib was given for two weeks, followed by one week off.
Read more
Patients are assessed for measurable disease at baseline, 6 weeks, 12 weeks after starting treatment, and every 9 weeks thereafter according to RECIST 1.1 criteria during the treatment period until disease progression or intolerable toxicity withdrawal. Following discontinuation of treatment, subjects are followed for survival status every 3 months until death. Subject safety was assessed during treatment according to NCI CTCAE Version 4.0 criteria. Subjects who experience an AE should be followed until the AE returns to baseline. The primary endpoints is Progression-free survival (PFS) . Secondary endpoints include objective response rate (ORR), overall survival (OS) and safety (NCI CTCAE v 4.0).
Statistical methods: The PFS curve was estimated using the Kaplan-Meier method for the largest population to be analyzed. The confidence interval method was used as the criterion for the main analysis. OS was calculated in the same way as the secondary endpoint. Descriptive statistics will be used to analyze ORR, DCR, etc. It is expected that almonertinib plus anlotinib as first-line treatment will prolong median PFS and OS of advanced non-small cell lung cancer with EGFR sensitive mutation and TP53 mutation patients.
Read the detailed description
Lung cancer is the most common solid tumor and the leading cause of cancer-related death in the world [1]. According to the Globocan analysis report of global cancer epidemic statistics in 2023, the number of new cases of lung cancer in the world reached 238,400, and the number of deaths reached 127,100, ranking first in all cancers [2]. There are about 815,000 new cases and 715,000 deaths in China every year, accounting for 23.8% of the total cancer deaths [1]. Non-small Cell Lung Cancer (NSCLC) is the most common pathological type of lung cancer, accounting for about 85% of all lung cancers [3]. About 70% of patients are locally advanced or advanced at the time of diagnosis, and only 25% of patients with NSCLC survive for more than 5 years after diagnosis. When patients receive traditional cytotoxic chemotherapy regimens, the 5-year relative survival rate of patients with advanced NSCLC is only 6%[4-6]. However, with the application of targeted therapy and immunotherapy in recent years, the 5-year survival rate of NSCLC patients receiving immunotherapy or targeted therapy can reach 15% to 50%[7-10].
EGFR mutation is one of the most common mutations in NSCLC, especially in lung adenocarcinoma.Since 2014, EGFR-TKI has become the standard first-line treatment for NSCLC patients with EGFR classical mutations.For advanced NSCLC patients with EGFR sensitive mutations and TP53 mutations, the benefit of single drug may be limited. Combination therapy may improve the survival and quality of life of advanced NSCLC patients with EGFR sensitive mutations and TP53 co-mutations, but there is still a lack of sufficient clinical trials to verify.
Almonertinib is a novel irreversible third-generation TKI. It is used for the treatment of adult patients with locally advanced or metastatic NSCLC with T790M mutation positive after prior EGFR-TKI treatment. The AENEAS study [25] is a multicenter, randomized, controlled, double-blind, phase III clinical trial comparing the efficacy and safety of almonertinib and gefitinib as first-line treatment for patients with locally advanced or metastatic NSCLC with EGFR19Del or L858R mutation. 429 untreated patients with locally advanced or metastatic disease harboring the EGFR19Del or L858R mutation were randomized to receive almonertinib at a dose of 110mg daily (n=214) or gefitinib at a dose of 250mg daily (n=215). The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), duration of response (DoR), and disease control rate (DCR). The results showed that the mPFS of almonertinib group and gefitinib group were 19.3 months and 9.9 months, ORR were 73.8% and 72.1%, DCR were 93.0% and 96.7%, DOR were 18.1 months and 8.3 months. Based on this study, on December 16, 2021, the NMPA officially approved almonertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR19Del or exon 21 L858R mutation.
Anlotinib is a novel multi-target oral tyrosine kinase inhibitor developed by China. It can effectively inhibit VEGFR, PDGFR, FGFR, PDGFRα and β and stem cell growth factor receptor (c-Kit) and other kinases, so it can play an effective role in anti-tumor angiogenesis and inhibition of tumor cell growth [29, 30]. A number of clinical trials have confirmed the significant efficacy of anlotinib in patients with advanced NSCLC. ALTER-0303 trial [31] was a randomized, double-blind, multicenter, controlled phase III clinical trial of anlotinib as a third-line or longer treatment for advanced NSCLC patients. A total of 437 subjects were enrolled in the study and randomly assigned to anlotinib group (n=294) and placebo group (n=143) at a ratio of 2:1. The primary endpoint was overall survival (OS). The secondary endpoints were PFS, ORR, DCR, Quality of Life (QoL), and safety. The results showed that anlotinib was superior to placebo in terms of OS and PFS. The median OS (mOS) and mPFS were 9.6 and 5.4 months, respectively, in the anlotinib group, and 6.3 and 1.4 months, respectively, in the placebo group. Meanwhile, the results of exploratory subgroup analysis showed that advanced NSCLC with EGFR mutation or EGFR wild type could benefit from clinical treatment in terms of OS and PFS. Based on this experimental result, on May 8, 2018, the China Food and Drug Administration (CFDA) officially approved single-agent anlotinib for the third-line and beyond treatment of advanced NSCLC patients.
To evaluate the efficacy and safety of almonertinib plus anlotinib as first-line treatment for advanced non-small cell lung cancer with EGFR sensitive mutation and TP53 mutation.
This study is an exploratory single-arm study. The specific treatment regimen is as follows: Non-squamous NSCLC: almonertinib (110 mg/d) plus anlotinib (12mg/d) is started on the first day of each treatment cycle and administered every three weeks until disease progression or intolerable toxicity. Anlotinib was given for two weeks, followed by one week off.
Patients are assessed for measurable disease at baseline, 6 weeks, 12 weeks after starting treatment, and every 9 weeks thereafter according to RECIST 1.1 criteria during the treatment period until disease progression or intolerable toxicity withdrawal. Following discontinuation of treatment, subjects are followed for survival status every 3 months until death. Subject safety was assessed during treatment according to NCI CTCAE Version 4.0 criteria. Subjects who experience an AE should be followed until the AE returns to baseline. The primary endpoints is Progression-free survival (PFS) . Secondary endpoints include objective response rate (ORR), overall survival (OS) and safety (NCI CTCAE v 4.0).
Statistical methods: The PFS curve was estimated using the Kaplan-Meier method for the largest population to be analyzed. The confidence interval method was used as the criterion for the main analysis. OS was calculated in the same way as the secondary endpoint. Descriptive statistics will be used to analyze ORR, DCR, etc. It is expected that almonertinib plus anlotinib as first-line treatment will prolong median PFS and OS of advanced non-small cell lung cancer with EGFR sensitive mutation and TP53 mutation patients.
- Conditions
- Advanced Non-small Cell Lung Cancer
- Being tested
- almonertinib
- Keywords
- almonertinib, anlotinib, EGFR mutation, TP53 mutation, advanced non-small cell lung cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
almonertinibDrug
Also called Anlotinib
The specific treatment regimen is as follows: Non-squamous NSCLC: almonertinib (110 mg/d) plus anlotinib (12mg/d) is started on the first day of each treatment cycle and administered every three weeks until disease progression or intolerable toxicity. Anlotinib was given for two weeks, followed by one week off.
| Study group | Role | What they receive |
|---|---|---|
| almonertinib plus anlotinib | Experimental | The specific treatment regimen is as follows: Non-squamous NSCLC: almonertinib (110 mg/d) plus anlotinib (12mg/d) is started on the first day of each treatment cycle and administered every three weeks until disease progression or intolerable toxicity. Anlotinib was given for two weeks, followed by one week off. Receives: Drug: almonertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months]
Secondary outcomes (3)
OS
overall survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
ORR
objective response rate
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
DOR
Duration of Responst
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, 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 posted21 Sep 2023
- Study start1 Sep 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion30 Jun 2027 (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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Degan Lu, Principal investigator, he First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043973
- Sponsor's protocol ID
- YXLL-KY-2023(090)
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 21 Sep 2023
- 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-center, Single-arm Clinical Study of Almonertinib Combined With Anlotinib as First-line Treatment for Advanced Non-small Cell Lung Cancer With EGFR Sensitive Mutation and TP53 Mutation
- ClinicalTrials.gov ID
- NCT06043973
- Acronym / sponsor ID
- YXLL-KY-2023(090)
- Conditions
- Advanced Non-small Cell Lung Cancer
- Keywords
- almonertinib, anlotinib, EGFR mutation, TP53 mutation, advanced non-small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 21 Sep 2023 (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.
To evaluate the efficacy and safety of almonertinib plus anlotinib as first-line treatment for advanced non-small cell lung cancer with EGFR sensitive mutation and TP53 mutation.
This study is an exploratory single-arm study. The specific treatment regimen is as follows: Non-squamous NSCLC: almonertinib (110 mg/d) plus anlotinib (12mg/d) is started on the first day of each treatment cycle and administered every three weeks until disease progression or intolerable toxicity. Anlotinib was given for two weeks, followed by one week off.
Patients are assessed for measurable disease at baseline, 6 weeks, 12 weeks after starting treatment, and every 9 weeks thereafter according to RECIST 1.1 criteria during the treatment period until disease progression or intolerable toxicity withdrawal. Following discontinuation of treatment, subjects are followed for survival status every 3 months until death. Subject safety was assessed during treatment according to NCI CTCAE Version 4.0 criteria. Subjects who experience an AE should be followed until the AE returns to baseline. The primary endpoints is Progression-free survival (PFS) . Secondary endpoints include objective response rate (ORR), overall survival (OS) and safety (NCI CTCAE v 4.0).
Statistical methods: The PFS curve was estimated using the Kaplan-Meier method for the largest population to be analyzed. The confidence interval method was used as the criterion for the main analysis. OS was calculated in the same way as the secondary endpoint. Descriptive statistics will be used to analyze ORR, DCR, etc. It is expected that almonertinib plus anlotinib as first-line treatment will prolong median PFS and OS of advanced non-small cell lung cancer with EGFR sensitive mutation and TP53 mutation patients.
Detailed description
Lung cancer is the most common solid tumor and the leading cause of cancer-related death in the world [1]. According to the Globocan analysis report of global cancer epidemic statistics in 2023, the number of new cases of lung cancer in the world reached 238,400, and the number of deaths reached 127,100, ranking first in all cancers [2]. There are about 815,000 new cases and 715,000 deaths in China every year, accounting for 23.8% of the total cancer deaths [1]. Non-small Cell Lung Cancer (NSCLC) is the most common pathological type of lung cancer, accounting for about 85% of all lung cancers [3]. About 70% of patients are locally advanced or advanced at the time of diagnosis, and only 25% of patients with NSCLC survive for more than 5 years after diagnosis. When patients receive traditional cytotoxic chemotherapy regimens, the 5-year relative survival rate of patients with advanced NSCLC is only 6%[4-6]. However, with the application of targeted therapy and immunotherapy in recent years, the 5-year survival rate of NSCLC patients receiving immunotherapy or targeted therapy can reach 15% to 50%[7-10].
EGFR mutation is one of the most common mutations in NSCLC, especially in lung adenocarcinoma.Since 2014, EGFR-TKI has become the standard first-line treatment for NSCLC patients with EGFR classical mutations.For advanced NSCLC patients with EGFR sensitive mutations and TP53 mutations, the benefit of single drug may be limited. Combination therapy may improve the survival and quality of life of advanced NSCLC patients with EGFR sensitive mutations and TP53 co-mutations, but there is still a lack of sufficient clinical trials to verify.
Almonertinib is a novel irreversible third-generation TKI. It is used for the treatment of adult patients with locally advanced or metastatic NSCLC with T790M mutation positive after prior EGFR-TKI treatment. The AENEAS study [25] is a multicenter, randomized, controlled, double-blind, phase III clinical trial comparing the efficacy and safety of almonertinib and gefitinib as first-line treatment for patients with locally advanced or metastatic NSCLC with EGFR19Del or L858R mutation. 429 untreated patients with locally advanced or metastatic disease harboring the EGFR19Del or L858R mutation were randomized to receive almonertinib at a dose of 110mg daily (n=214) or gefitinib at a dose of 250mg daily (n=215). The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), duration of response (DoR), and disease control rate (DCR). The results showed that the mPFS of almonertinib group and gefitinib group were 19.3 months and 9.9 months, ORR were 73.8% and 72.1%, DCR were 93.0% and 96.7%, DOR were 18.1 months and 8.3 months. Based on this study, on December 16, 2021, the NMPA officially approved almonertinib for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR19Del or exon 21 L858R mutation.
Anlotinib is a novel multi-target oral tyrosine kinase inhibitor developed by China. It can effectively inhibit VEGFR, PDGFR, FGFR, PDGFRα and β and stem cell growth factor receptor (c-Kit) and other kinases, so it can play an effective role in anti-tumor angiogenesis and inhibition of tumor cell growth [29, 30]. A number of clinical trials have confirmed the significant efficacy of anlotinib in patients with advanced NSCLC. ALTER-0303 trial [31] was a randomized, double-blind, multicenter, controlled phase III clinical trial of anlotinib as a third-line or longer treatment for advanced NSCLC patients. A total of 437 subjects were enrolled in the study and randomly assigned to anlotinib group (n=294) and placebo group (n=143) at a ratio of 2:1. The primary endpoint was overall survival (OS). The secondary endpoints were PFS, ORR, DCR, Quality of Life (QoL), and safety. The results showed that anlotinib was superior to placebo in terms of OS and PFS. The median OS (mOS) and mPFS were 9.6 and 5.4 months, respectively, in the anlotinib group, and 6.3 and 1.4 months, respectively, in the placebo group. Meanwhile, the results of exploratory subgroup analysis showed that advanced NSCLC with EGFR mutation or EGFR wild type could benefit from clinical treatment in terms of OS and PFS. Based on this experimental result, on May 8, 2018, the China Food and Drug Administration (CFDA) officially approved single-agent anlotinib for the third-line and beyond treatment of advanced NSCLC patients.
To evaluate the efficacy and safety of almonertinib plus anlotinib as first-line treatment for advanced non-small cell lung cancer with EGFR sensitive mutation and TP53 mutation.
This study is an exploratory single-arm study. The specific treatment regimen is as follows: Non-squamous NSCLC: almonertinib (110 mg/d) plus anlotinib (12mg/d) is started on the first day of each treatment cycle and administered every three weeks until disease progression or intolerable toxicity. Anlotinib was given for two weeks, followed by one week off.
Patients are assessed for measurable disease at baseline, 6 weeks, 12 weeks after starting treatment, and every 9 weeks thereafter according to RECIST 1.1 criteria during the treatment period until disease progression or intolerable toxicity withdrawal. Following discontinuation of treatment, subjects are followed for survival status every 3 months until death. Subject safety was assessed during treatment according to NCI CTCAE Version 4.0 criteria. Subjects who experience an AE should be followed until the AE returns to baseline. The primary endpoints is Progression-free survival (PFS) . Secondary endpoints include objective response rate (ORR), overall survival (OS) and safety (NCI CTCAE v 4.0).
Statistical methods: The PFS curve was estimated using the Kaplan-Meier method for the largest population to be analyzed. The confidence interval method was used as the criterion for the main analysis. OS was calculated in the same way as the secondary endpoint. Descriptive statistics will be used to analyze ORR, DCR, etc. It is expected that almonertinib plus anlotinib as first-line treatment will prolong median PFS and OS of advanced non-small cell lung cancer with EGFR sensitive mutation and TP53 mutation patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| almonertinib plus anlotinib | Experimental | Drug: almonertinibThe specific treatment regimen is as follows: Non-squamous NSCLC: almonertinib (110 mg/d) plus anlotinib (12mg/d) is started on the first day of each treatment cycle and administered every three weeks until disease progression or intolerable toxicity. Anlotinib was given for two weeks, followed by one week off. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Metastatic Non-squamous NSCLC is histologically or cytologically proven to be inoperable and cannot receive radical concurrent chemoradiotherapy. The conventional TNM stage was identified as stage IIIa-Ⅳb according to the International Association for the Study of Lung Cancer and the American Joint Committee on the Classification of Cancer 8th edition TNM Staging of Lung Cancer.
- Patients with EGFR mutation and TP53 mutation advanced Non-squamous NSCLC. Patients who had not previously received systemic radiotherapy and chemotherapy or who had relapsed for more than 6 months of follow-up after onset of adjuvant chemotherapy.
- At least one measurable lesion as determined by RECIST criteria. Male or female patients, age: 18-75 years of age. Performance score 0-1 based on Eastern Cooperative Oncology Group (ECOG) test. Expected survival period ≥12 weeks. Serum absolute number of neutrophils≥ 1.5 x 10^9/L, platelet ≥ 100 x10^9/L, and hemoglobin≥ 90g/L.
- Serum bilirubin≤1.5 times ULNL, aspartate aminotransferase (AST) and adenosine triphosphate(ALT) ≤ 2.5 times ULN, alkaline phosphatase ≤ 5 times ULN.
- Serum creatinine≤ the ULN or creatinine clearance ≥ 60 mL/min. Patients who had previously undergone surgery have recovered for more than 4 weeks from the beginning of the project.
Key exclusion criteria (12 listed)
- Those who are known to be allergic to the study drug almonertinib and anlotinib and its any components.
- Intolerance to study drug treatment or allergy to the active ingredients or excipients of combined chemotherapy drugs.
- Pregnancy or breastfeeding women or women who may be pregnant but are unwilling to take appropriate contraception.
- Existing severe acute infections that are not under control; Or suppurative and chronic infections with delayed healing.
- Pre-existing serious heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina pectoris, myocardial infarction, severe valvular heart disease, and refractory hypertension.
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: AnlotinibThe specific treatment regimen is as follows: Non-squamous NSCLC: almonertinib (110 mg/d) plus anlotinib (12mg/d) is started on the first day of each treatment cycle and administered every three weeks until disease progression or intolerable toxicity. Anlotinib was given for two weeks, followed by one week off. | Drug | almonertinib plus anlotinib |
Primary outcome
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months]
Progression-free survival
3 secondary outcomes
OS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
ORR
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
DOR
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- 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.
Degan Lu principal investigator
he First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing almonertinib 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 8 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 21 Sep 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Degan Lu, Professor (18753157623, deganlu@126.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 date of randomization until the date of first documented progression or date of death from any cause, 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 21 Sep 2023.