Clinical Study of Ametinib Combined With Bevacizumab in First-line Treatment of Advanced NSCLC With EGFR-mutations.

NCT05754736 | Unknown Phase 2

• 1 other identifier: MT-005
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the intracranial/extracranial ORR, PFS, QoL, safety, dynamic changes of tissue, cerebrospinal fluid, and plasma DNA in patients with newly diagnosed advanced NSCLC with EGFR mutation with/without brain metastasis given first-line treatment with almonertinib combined with bevacizumab at the initial stage of treatment, during treatment and after drug resistance, and the correlation between early clearance of sensitive mutations and survival.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate

  It refers to the proportion of patients (mainly solid tumors) whose tumor has shrunk to a certain extent and remained there for a certain period of time, including Complete Response (CR) and Partial Response (PR)

  2 years

• Progression Free Survival

  The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse

  2 years

Secondary Outcomes (5)

• Intracranial Objective Response Rate

  2 year

• Intracranial Progression Free Survival

  2 year

• Overall Survival

  3 year

• Quality of life score

  3 year

• Adverse event

  3 year

Study Arms (1)

Ametinib combined with bevacizumab

EXPERIMENTAL

Ametinib 110 mg po qd bevacizumab 15mg/kg ivdrip q3w

Drug: Ametinib combined with bevacizumab

Interventions

Ametinib combined with bevacizumab DRUG

Ametinib 110mg po qd bevacizumab 15mg/kg ivdrip q3w

Also known as: Third-generation TKI combined with antivascular targeting drug

Ametinib combined with bevacizumab

Eligibility Criteria

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

You may qualify if:

• Male or female, ≥18 years old and ≤75years old;
• Non-squamous non-small cell lung cancer (NSCLC) confirmed by pathology (including histology or cytology); ③ EGFR mutation positive (exon 19 deletion or exon 21 L858R mutation); (4) ≥3 intracranial metastases, asymptomatic brain metastases; (5) Never received antitumor therapy before;
• There was at least 1 measurable intracranial and extracranial lesion in CT/MRI according to RECIST1.1 criteria.
• ⑦ Predicted survival ≥3 months;
• ⑧ ECOG score 0-1;
• ⑨ The main organs (liver, kidney, heart) function normally.
• ⑩ Sign informed consent forms.

You may not qualify if:

• The intracranial metastases were oligometastases;
• There are symptoms of increased intracranial pressure; (3) Previous or co-existing malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); (4) Patients with hypertension and can not be reduced to the normal range after antihypertensive drug treatment, have grade I coronary heart disease, grade I arrhythmia and grade I cardiac insufficiency;
• Patients with definite tendency to gastrointestinal bleeding; ⑥ with hemoptysis symptoms; ⑦ Abnormal coagulation function (INR\>1.5, APTT\>1.5 ULN), with bleeding tendency; ⑧ Have a history of psychotropic drug abuse and can not abstain or have mental disorders; ⑨According to the investigator's judgment, Patients who have a serious concomitant disease that endangers the patient's safety or affects the patient's completion of the study, and who have previous or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severe impairment of lung function.

Sponsors & Collaborators

• The Second Affiliated Hospital of Shandong First Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Shandong First Medical University

Tai’an, Shandong, 271000, China

RECRUITING

Related Publications (3)

• Ramotar M, Barnes S, Moraes F, Dasgupta A, Laperriere N, Millar BA, Berlin A, Conrad T, van Prooijen M, Damyanovich A, Heaton R, Cho YB, Coolens C, Liu G, Shepherd FA, Bradbury P, Leighl N, Bernstein M, Zadeh G, Kongkham P, Doherty M, Shultz DB. Neurological Death is Common in Patients With EGFR Mutant Non-Small Cell Lung Cancer Diagnosed With Brain Metastases. Adv Radiat Oncol. 2019 Nov 26;5(3):350-357. doi: 10.1016/j.adro.2019.11.002. eCollection 2020 May-Jun.

  PMID: 32529128 RESULT

• Yoneda K, Imanishi N, Ichiki Y, Tanaka F. Treatment of Non-small Cell Lung Cancer with EGFR-mutations. J UOEH. 2019;41(2):153-163. doi: 10.7888/juoeh.41.153.

  PMID: 31292359 RESULT

• Passiglia F, Pilotto S, Facchinetti F, Bertolaccini L, Del Re M, Ferrara R, Franchina T, Malapelle U, Menis J, Passaro A, Ramella S, Rossi G, Trisolini R, Novello S. Treatment of advanced non-small-cell lung cancer: The 2019 AIOM (Italian Association of Medical Oncology) clinical practice guidelines. Crit Rev Oncol Hematol. 2020 Feb;146:102858. doi: 10.1016/j.critrevonc.2019.102858. Epub 2019 Dec 28.

  PMID: 31918343 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Haiyan Liu

  The Second Affiliated Hospital of Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Kong

CONTACT

13153882807; kongyingcoco@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: February 22, 2023
• First Posted: March 6, 2023
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: March 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)