Furmonertinib Combined With Anlotinib as the First-line Treatment in Patients With EGFR Mutation-positive NSCLC

NCT04895930 | Unknown Phase 2

• 1 other identifier: AST-PMR2002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this phase Ⅱ study is to evaluate the efficacy and safety of Furmonertinib combined with Anlotinib as the first-line treatment in locally advanced or metastatic non-small cell lung cancer with sensitive EGFR mutations.

Conditions

Non-Small-Cell Lung Cancer

Keywords

EGFR mutations; furmonertinib; anlotinib; non-squamous NSCLC

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Proportion of subjects whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1.

  Approximately 3 years following the first dose of study drugs

Secondary Outcomes (4)

• Disease Control Rate (DCR)

  Approximately 3 years following the first dose of study drugs

• Duration of Response (DOR)

  Approximately 3 years following the first dose of study drugs

• Disease progression free survival (PFS)

  Approximately 3 years following the first dose of study drugs

• Adverse Events

  Until 30 days from the last dose of study drugs or initiation of a new anticancer treatment

Study Arms (1)

Furmonertinib Plus Anlotinib

EXPERIMENTAL

Furmonertinib (80mg) plus Anlotinib (10mg)

Drug: Furmonertinib; Drug: Anlotinib

Interventions

Furmonertinib DRUG

80mg/day orally on a continuous dosing schedule. If subjects suffer from AEs, they can get declined dosage (40mg).

Also known as: AST2818

Furmonertinib Plus Anlotinib

Anlotinib DRUG

10mg/day orally from day 1 to 14 of a 21-day cycle. If subjects suffer from AEs, they can get declined dosage (8mg).

Furmonertinib Plus Anlotinib

Eligibility Criteria

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

You may qualify if:

• Subjects have voluntarily participated, signed and dated informed consent;
• Male or female subjects aged ≥18 and ≤75 years old;
• Locally advanced or metastatic adenocarcinoma NSCLC confirmed by histology or cytology (according to the 8th Edition of the AJCC Staging system), not suitable for surgery or radiotherapy;
• ECOG score 0-1, and life expectancy no less than 12 weeks according to the investigator's assessment;
• The tumour harbours one of the most common EGFR mutations (19del or L858R) ;
• According to RECIST 1.1, subjects have at least one measurable tumor lesion at baseline, and had not received radiotherapy previously;
• No previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC. For recurrent disease, adjuvant therapy or neoadjuvant therapy may be accepted, but recurrence occurs ≥6 months from stopping treatment;
• Subjects with stable clinical symptoms of pleural effusion or ascites after symptomatic treatment;
• For premenopausal women with fertility, the result of serum or urine pregnancy test should be negative within 7 days before the first dose.

You may not qualify if:

• Not lung adenocarcinoma, including lung squamous carcinoma, or mixed histology, etc;
• Subjects are expected to participate in other clinical studies during this trial period;
• Imaging evidence showed that the tumor had invaded critical blood vessels;
• Subjects who receive systemic anti-tumor therapy used for locally advanced or metastatic NSCLC previously;
• With other malignant tumors at present or history of other malignant tumors within 5 years;
• Leptomeningeal metastases or central nervous system metastasis requiring emergency treatment;
• At the beginning of study treatment, any unresolved toxic reaction to prior treatment (e.g., adjuvant chemotherapy) exceeds CTCAE Grade 1;
• History of ILD, drug-induced ILD, radiation pneumonitis which require steroid treatment, or with suspected clinical manifestations of ILD or high risk factors;
• Severe gastrointestinal dysfunction may affect the intake, transport or absorption of the study drugs;
• Recent active digestive diseases or other conditions that may cause gastrointestinal bleeding or perforation;
• Presence of bleeding constitution or active bleeding; any bleeding event ≥CTCAE grade 3, unhealed wounds, ulcers, or fractures occurred within 28 days prior to the first dose;
• Any of the following organ function criteria is met (no blood or blood product transfusions, no hematopoietic stimulating factors, no albumin or blood product transfusions within 7 days prior to examination): Absolute value of neutrophil (NE)\<1.5 × 109/L, platelet (PLT) count\<90 × 109/L, hemoglobin (HGB)\<90 g/L; Serum total bilirubin (TBIL)\>1.5 × ULN, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)\>2.5 × ULN (for liver metastases or Gilbert Syndrome, TBIL\>3 × ULN, and AST and/or ALT\>5 × ULN); Serum creatinine (SCr)\>1.5 × ULN, or creatinine clearance\<60ml/min. (According to the Cockcroft and Gault formula); Urinary protein ≥ ++, or 24-hour urine protein\>1.0g; International normalized ratio（INR）\>1.5 and activated partial thromboplastin time (APTT)\>1.5 ULN; Fasting blood glucose \>10mmol/L；
• Any of the following cardiac criteria is met：
• At rest, the mean corrected QT interval (QTc) by ECG \> 470 msec；
• Seriously abnormal of heart rhythm, conduction, or morphology of resting ECG;

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• Allist Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related Publications (1)

• Shi Y, Hu X, Zhang S, Lv D, Wu L, Yu Q, Zhang Y, Liu L, Wang X, Cheng Y, Ma Z, Niu H, Wang D, Feng J, Huang C, Liu C, Zhao H, Li J, Zhang X, Jiang Y, Gu C. Efficacy, safety, and genetic analysis of furmonertinib (AST2818) in patients with EGFR T790M mutated non-small-cell lung cancer: a phase 2b, multicentre, single-arm, open-label study. Lancet Respir Med. 2021 Aug;9(8):829-839. doi: 10.1016/S2213-2600(20)30455-0. Epub 2021 Mar 26.

  PMID: 33780662 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

aflutinib; anlotinib

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Baohui Han, MD

CONTACT

+86 021-22200000; xkyyhan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 20, 2021
• Study Start: October 12, 2021
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: January 6, 2023

Record last verified: 2023-01

Locations

CN (1)