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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Aumolertinib,Anlotinib

Treatment groups

47 Participants
are divided into 1 treatment group

Locations

This trial has no locations