Almonertinib as Upfront Treatment for Uncommon EGFR Mutation Harboring Non-Small-Cell Lung Cancer Patients: A Multicenter, Open-Label, Phase II Trial

NCT04553887 | Unknown Phase 2

• 1 other identifier: AUTUMN
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2 study to evaluate the efficacy and the safety/ tolerability of Almonertinib in NSCLC patients with uncommon EGFR Mutation or EGFR exon 20 insertion mutations. Patients with EGFR exon 20 insertion mutations have to had at least one prior systemic treatment for locally advanced or metastatic NSCLC.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The proportion of subjects who achieve Complete Response (CR) and Partial Response (PR) by the best response from the first dose of Almonertinib to the end of study.

  To evaluate objective response rate 6-8 weeks after the initiation of Almonertinib

Secondary Outcomes (5)

• Progression Free Survival

  30 months

• Disease Control Rate

  30 months

• Overall Survival

  30 months

• Duration of Response

  30 months

• Safety and Tolerability

  30 months

Study Arms (2)

Cohort 1

EXPERIMENTAL

Previously treated NSCLC patients with EGFR exon 20 insertion mutantion

Drug: Almonertinib

Cohort 2

EXPERIMENTAL

NSCLC Patients with uncommon EGFR Mutation

Drug: Almonertinib

Interventions

Almonertinib DRUG

single agent, 110mg p.o once daily until disease progressed

Cohort 1; Cohort 2

Eligibility Criteria

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

You may qualify if:

• years#ECOG PS#0-2#Life expectancy of more than 3 months#with measurable lesion ( RECIST1.1).
• Cohort A: Patients with EGFR exon 20 insertion, failure of first-line standard chemotherapy, or intolerance to chemotherapy Cohort B: Patients with uncommen EGFR mutations but without exon 19 deletion, L858R, T790M, and exon 20 insertion
• ≥1 target lesion that has not received radiotherapy in the past 3 months and can be accurately measured in at least 1 direction#Previously received radiation therapy, but the radiotherapy area must be \<25% of the bone marrow area, and radiation therapy must have closed for at least≥4 weeks at the time of enrollment.
• Main organs function is normal.
• Signed and dated informed consent.

You may not qualify if:

• \. Patient has had previous treatment with Pyrotinib, Poziotinib or any other EGFR or HER2 exon 20 insertion mutation-selective tyrosine kinase inhibitor (TKI) prior to study participation. The currently approved TKIs (ie, erlotinib, gefitinib, afatinib, osimertinib) are not considered to be exon 20 insertion-selective and are permissible
• Patients with EGFR 19 exon deletion mutation, 21 exon L858R mutation or 20 exon T790M mutation.
• Small cell lung cancer (including mixed small cell and non-small cell lung cancer);
• Cohort A: Patients who had previously used the third generation of EGFR-TKI (including Almonertinib, Osimertinib, etc.) Cohort B: Patients who had previously used EGFR-TKI
• Patients who planned to receive systemic anti-tumor therapy within 4 weeks prior to allocation or during the course of this study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or receiving the Mitomycin C 6 weeks prior to medication). Extra-field radiotherapy (EF-RT) was performed 4 weeks prior to allocation or restricted radiotherapy for assessing tumor lesions within 2 weeks prior to allocation
• With kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)
• Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Almonertinib
• History of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or history of organ transplantation; active infection including hepatitis B (HBV DNA level ≥1000 copies /mL), hepatitis C and human immunodeficiency virus (HIV); Severe acute or chronic infections requiring systemic treatment
• Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial
• Known history of neurological or psychiatric disease, including epilepsy or dementia
• Has a history of malignant tumors. Except for patients with cutaneous basal cell carcinoma, superficial bladder cancer, cutaneous squamous cell carcinoma or orthotopic cervical cancer who have undergone curative treatment and have no disease recurrence within 5 years after the start of treatment
• Respiratory syndrome (dyspnea≥CTC AE 2), severe pleural effusion, ascites, pericardial effusion
• Patient has had other malignancies within the past 3 years, except for stable non-melanoma skin cancer, fully treated and stable early stage prostate cancer or carcinoma in situ of the cervix or breast without need of treatment
• Patient is pregnant or breast-feeding

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

aumolertinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Dingzhi Huang

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dingzhi Huang

CONTACT

86-22-23340123; dingzhih72@163.com

Study Design

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

Study Record Dates

• First Submitted: September 12, 2020
• First Posted: September 18, 2020
• Study Start: November 1, 2020
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: October 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data access requests will be reviewed by an external indepentent Review Panel. Requestors will be required to sign a Data Access Agreement.

Locations

CN (1)