Safety and Efficacy of Aumolertinib Combined With Anlotinib as 1st Line Treatment in Advanced Lung Cancer EGFR Mutation With TP53 Co-Mutation

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · Mar 8, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of two medications, Aumolertinib and Anlotinib, used together as a first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) who have specific genetic changes called EGFR mutations and TP53 co-mutations. The study aims to include 47 patients who are newly diagnosed and have not received any previous systemic treatment for their cancer. To be eligible, participants must be between 18 and 85 years old, have measurable cancer, and have normal functioning of key organs.

Participants in this trial will take Aumolertinib daily and Anlotinib for two weeks at a time, with treatment cycles continuing until the cancer worsens, they experience intolerable side effects, or they pass away. The trial is currently not recruiting participants, but it’s important for potential candidates to know that they will be closely monitored throughout the study. This research could help determine if this combination treatment is a viable option for patients like them with advanced lung cancer.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Locally advanced or metastatic NSCLC EGFR sensitive mutations (19del and L858R) and TP53 co-mutation;
• • 2. Age 18-85 years, male or female;
• • 3. Have not received systematic treatment; If the subject has received adjuvant therapy after completing radical treatment for early gastric cancer and the subject has relapsed disease, ensure that the end of adjuvant therapy is more than 6 months from the first dose of the study and that various toxicities due to the adjuvant therapy have recovered;
• • 4. ECOG 0-1, The expected survival is more than 6 months;
• • 5. At least one assessable lesion (RECIST 1.1 );
• 6. If the main organs function normally, they meet the following standards:
• • 1. Absolute value of neutrophils (ANC) ≥ 1.5 × 10 \^ 9 /L;
• • 2. platelet count ≥ 100 × 10 \^ 9 /L
• • 3. hemoglobin ≥ 90g /L;
• • 4. white blood cell ≥ 3.0 × 10\^9\\/L；
• • 5. Liver function: total bilirubin\<1.5 times the upper limit of normal value, aspartate aminotransferase (AST /SGOT), alanine aminotransferase (ALT /SGPT) and alkaline phosphatase (ALP) ≤ 2.5 times the upper limit of normal value; In case of liver metastasis, AST and ALT ≤ 5.0 times the upper limit of normal value; In case of liver metastasis and/or bone metastasis, ALP ≤ 5.0 times the upper limit of normal value.
• • 6. Renal function: serum creatinine (Scr) ≤ 1.5 times the upper limit of normal value; Urine routine test: urine protein\<2 (+); If the urine protein at baseline is ≥ 2 (+), the 24-hour urine protein quantity must be ≤ 1.0g;
• • 7. Coagulation function: international normalized ratio (INR) ≤ 1.5, and activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal value;
• Exclusion Criteria:
• • 1. Squamous cell carcinoma (including adenosquamous carcinoma and undifferentiated carcinoma); Small cell lung cancer (including small cell and non-small cell mixed lung cancer); Patients who have received systemic therapy in the past (allow to receive adjuvant or neoadjuvant therapy in the past);
• • 2. Patients with symptomatic brain metastasis at the beginning of treatment (patients with brain metastasis who have received treatment in the past are eligible if asymptomatic brain metastasis lasts for at least 4 weeks when receiving stable dose of drug treatment);
• • 3. . Patients who participated in the intervention tumor clinical trial during the first-line treatment or within the last 30 days before the first-line treatment;
• • 4. History of tracheoesophageal fistula, gastrointestinal perforation or gastrointestinal fistula and intra-abdominal abscess within 6 months before treatment;
• • 5. Suffer from serious cardio-cerebrovascular disease;
• • 6. Subjects who received chest radiotherapy in the lung field within the first 4 weeks, or who have not recovered from radiotherapy-related toxicity. Subjects who received radiotherapy or did not recover from radiotherapy-related toxicity within 2 weeks before randomization for all other anatomical sites;
• • 7. Major surgical treatment was performed within 4 weeks before treatment or planned during the trial period (the researcher judged that there was bleeding risk or wound healing complications);
• • 8. . Have bleeding tendency, high bleeding risk or coagulation dysfunction, including thrombotic disease within 6 months before randomization and/or hemoptysis history within 3 months before randomization (single cough bleeding ≥ 2.5mL)
• • 9. Subjects with high suspicion of idiopathic pulmonary fibrosis, organic pneumonia, drug-related pneumonia, idiopathic pneumonia or active pneumonia on chest CT scan during screening period;
• • 10. Imaging examination showed that there was evidence of tumor invasion into large vessels, and the tumor had completely approached, surrounded or invaded the lumen of large vessels (such as pulmonary artery or superior vena cava);
• • 11. Subjects with hypertension (systolic blood pressure\>160mmHg or diastolic blood pressure\>100mmHg) that are still poorly controlled after treatment with two or more antihypertensive drugs in the screening period, and who have a history of hypertensive crisis or hypertensive brain disease in the past;
• • 12. Those with unhealed wounds, active digestive ulcer, fractures (excluding old healed fractures);
• • 13. Known or suspected to be allergic to aumolertinib and Anlotinib and/or other components of their preparations;
• • 14. Pregnant or lactating women;
• • 15. Women or male subjects of childbearing age who are unwilling to take effective contraceptive measures during the study period or within 6 months after the last administration of the study drug
• • 16. In addition to the above conditions, the researcher believes that there are other conditions that are not suitable for selection