Combining Anlotinib and Aumolertinib for Advanced Lung Cancer Treatment

A Prospective, Multicenter, Single-arm Clinical Study of the Combination of Anlotinib and Aumolertinib in the First-line Treatment of Advanced Non-small Cell Lung Cancer With EGFR 21L858R Mutation

This study is testing a combination of two drugs, anlotinib and aumolertinib, to see if they can help people with advanced lung cancer that has a specific genetic mutation feel better and live longer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Kunming Medical University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, anlotinib, aumolertinib
• Locations: 1 site (Kunming, Yunnan)
• Trial ID: NCT06102928 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the efficacy and safety of a combined treatment regimen of anlotinib and aumolertinib in patients with advanced non-small cell lung cancer (NSCLC) harboring the EGFR 21L858R mutation. Thirty participants diagnosed with locally advanced or metastatic NSCLC will be recruited and treated, with efficacy evaluated using the RECIST 1.1 criteria every 6 to 8 weeks. The study aims to assess median progression-free survival as the primary endpoint, alongside secondary endpoints including objective response rate and disease control rate. The study will continue until disease progression, intolerable toxicity, or withdrawal of consent occurs.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with advanced unresectable or metastatic NSCLC and confirmed EGFR 21L858R mutation.

Not a fit: Patients who have previously received systemic anti-tumor treatments or those with other types of lung cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced NSCLC with specific genetic mutations.

How similar studies have performed: While the combination of these specific therapies is novel, similar approaches in targeting EGFR mutations have shown promise in other studies.

Eligibility criteria

Inclusion 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) confirmed by histology or cytology, with the presence of EGFR 21 exon L858R mutation in the driving gene; 4) According to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1), at least one measurable lesion is used as the target lesion; 5) The Eastern Cancer Collaborative Group's Physical State Score (ECOG PS) is 0 to 3 points; 6) Expected survival time is more than 3 months; 7) Newly treated patients who have not received systematic anti-tumor treatment in the past, including radiotherapy and chemotherapy, targeted and immunotherapy; 8) The main organ function meets the following standards within 7 days before treatment:(1) Blood routine examination standard (without blood transfusion within 14 days): ① Hemoglobin (HB) ≥ 90g/L; ② Absolute value of neutrophils (ANC) ≥ 1.5 × 109/L; ③ Platelet (PLT) ≥ 80 × 109/L.(2) Biochemical examination should meet the following standards: ① Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); ② Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5ULN, if accompanied by liver metastasis, ALT and AST ≤ 5ULN; ③ Serum creatinine (Cr) ≤ 1.5ULN or creatinine clearance rate (CCr) ≥ 60ml/min.

Exclusion Criteria:

1. Mixed NSCLC containing other pathological components;
2. Poor blood pressure control (systolic blood pressure ≥ 150mmHg, diastolic blood pressure ≥ 100mmHg);
3. 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;
4. Have experienced arteriovenous thrombosis events within 6 months, such as cerebrovascular accidents, deep venous thrombosis, and pulmonary embolism in patients;
5. Patients with combined factors that affect oral medication, such as difficulty swallowing, gastrointestinal resection, chronic diarrhea, or intestinal obstruction;
6. Patients with symptomatic brain metastases;
7. 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;
8. Active or uncontrolled severe infections;
9. Severe liver dysfunction, cirrhosis, acute or chronic active hepatitis;
10. The urine routine results showed that the urine protein level was ≥++, and the 24-hour urine protein quantitative detection result was\>1.0g;
11. Active pulmonary tuberculosis;
12. Pregnant or lactating women;
13. According to the judgement of the researchers, the subjects may have other factors that may cause the study to be terminated midway, such as other serious illnesses (including mental illness) requiring concurrent treatment, serious laboratory test abnormalities, and accompanying family and social factors, which may affect the safety of the subjects or the collection of data and samples.

Where this trial is running

Kunming, Yunnan

• First Affiliated Hospital of Kunming University — Kunming, Yunnan, China (Recruiting)

Study contacts

• Study coordinator: Jianqing Zhang, Ph.D

Conditions Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor; non-small cell lung cancer; anlotinib; aumolertinib; combined therapy; efficacy