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

NCT05778149 | Not Yet Recruiting Phase 2

• 1 other identifier: AA-53
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this open, single-arm, exploratory phase II clinical study is to exploratory safety and efficacy in 1st line treatment in advanced lung cancer EGFR mutation with TP53 co-mutation. 47 patients are scheduled to be enrolled. Treatment regimen is aumolertinib 110mg p.o QD and Anlotinib 12mg oral for 2 weeks, three weeks a cycle, until disease progression or intolerable adverse reactions or death.

Conditions

Aumolertinib; Anlotinib; TP53; NSCLC; EGFR Activating Mutation

Outcome Measures

Primary Outcomes (1)

• PFS (Progression-Free-Survival)

  The time from randomization to tumor progression or death.The efficacy of this study was determined according to Recist version 1.1 criteria.

  24months

Secondary Outcomes (5)

• ORR（Objective Response Rate）

  24months

• DCR（Disease control rate）

  24months

• DOR（Duration of response）

  24months

• OS (Overall survival time)

  24months

• The Adverse Events

  24months

Study Arms (1)

Treatment

EXPERIMENTAL

single arm,Treatment plan: Aumolertinib 110mg p.o QD; Anlotinib 12mg, oral for 2 weeks, three weeks a cycle, until disease progression.

Drug: Aumolertinib,Anlotinib

Interventions

Aumolertinib,Anlotinib DRUG

Aumolertinib 110mg p.o QD; Anlotinib 12mg, oral for 2 weeks, three weeks a cycle, until disease progression.

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Locally advanced or metastatic NSCLC EGFR sensitive mutations (19del and L858R) and TP53 co-mutation;
• Age 18-85 years, male or female;
• 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;
• ECOG 0-1, The expected survival is more than 6 months;
• At least one assessable lesion (RECIST 1.1 );
• If the main organs function normally, they meet the following standards:
• Absolute value of neutrophils (ANC) ≥ 1.5 × 10 \^ 9 /L;
• platelet count ≥ 100 × 10 \^ 9 /L
• hemoglobin ≥ 90g /L;
• white blood cell ≥ 3.0 × 10\^9\\/L；
• 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.
• 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;
• Coagulation function: international normalized ratio (INR) ≤ 1.5, and activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal value;

You may not qualify if:

• 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);
• 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);
• 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;
• History of tracheoesophageal fistula, gastrointestinal perforation or gastrointestinal fistula and intra-abdominal abscess within 6 months before treatment;
• Suffer from serious cardio-cerebrovascular disease;
• 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;
• 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);
• 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)
• 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;
• 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);
• 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;
• Those with unhealed wounds, active digestive ulcer, fractures (excluding old healed fractures);
• Known or suspected to be allergic to aumolertinib and Anlotinib and/or other components of their preparations;
• Pregnant or lactating women;
• 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

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Interventions

aumolertinib; anlotinib

Central Study Contacts

Zhan sheng Jiang, Doctor

CONTACT

0086-022-23340123; zhjiang@tmu.edu.cn

Zhan Yu Pan, Doctor

CONTACT

0086-022-23340123; s0010027@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 21, 2023
• Study Start: March 31, 2023
• Primary Completion: March 31, 2025
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share