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New treatment option for Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor...
Official title A Clinical Study of the Combination of Anlotinib and Aumolertinib in the First-line Treatment of Advanced NSCLC With EGFR 21L858R Mutation
ClinicalTrials.gov ID: NCT06102928
What this study is testing
What is Combined therapy of anlotinib and aumolertinib?
Combined therapy of anlotinib and aumolertinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for non-small cell lung cancer with mutation in epidermal growth factor receptor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a prospective, multicenter, single arm clinical study. Thirty subjects who will have been diagnosed with locally advanced or metastatic non-small cell lung cancer with EGFR 21L858R mutation detected in lung cancer tissue or peripheral blood will be recruited and treated with anlotinib and aumolertinib.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1) The patient voluntarily participated in this study and signed an informed consent form; 2) Age\>18 years old, both male and female; 3) Advanced...
You likely can't join if
- Mixed NSCLC containing other pathological components;
- Poor blood pressure control (systolic blood pressure ≥ 150mmHg, diastolic blood pressure ≥ 100mmHg);
- Imaging shows that the tumor invades important blood vessels, or the researcher determines that the tumor is highly likely to invade important blood...
- Have experienced arteriovenous thrombosis events within 6 months, such as cerebrovascular accidents, deep venous thrombosis, and pulmonary embolism...
- Patients with combined factors that affect oral medication, such as difficulty swallowing, gastrointestinal resection, chronic diarrhea, or...
- Patients with symptomatic brain metastases;
See the full eligibility criteria
- 1) The patient voluntarily participated in this study and signed an informed consent form; 2) Age\>18 years old, both male and female; 3) Advanced stage unresectable or metastatic NSCLC (stage IIIB, IIIC, or IV)...
- Mixed NSCLC containing other pathological components;
- Poor blood pressure control (systolic blood pressure ≥ 150mmHg, diastolic blood pressure ≥ 100mmHg);
- Imaging shows that the tumor invades important blood vessels, or the researcher determines that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies;
- Have experienced arteriovenous thrombosis events within 6 months, such as cerebrovascular accidents, deep venous thrombosis, and pulmonary embolism in patients;
- Patients with combined factors that affect oral medication, such as difficulty swallowing, gastrointestinal resection, chronic diarrhea, or intestinal obstruction;
- Patients with symptomatic brain metastases;
- Patients with severe and/or uncontrollable diseases, such as myocardial infarction, unstable angina, congestive heart failure, and severe uncontrollable arrhythmias within 6 months prior to enrollment;
- Active or uncontrolled severe infections;
- Severe liver dysfunction, cirrhosis, acute or chronic active hepatitis;
- The urine routine results showed that the urine protein level was ≥++, and the 24-hour urine protein quantitative detection result was\>1.0g;
- Active pulmonary tuberculosis;
- Pregnant or lactating women;
- According to the judgement of the researchers, the people may have other factors that may cause the study to be terminated midway, such as other serious illnesses (including mental illness) requiring concurrent...
The study team makes the final eligibility decision.
Where it's taking place
- Kunming, Yunnan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kunming, Yunnan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.