Gefitinib With Anlotinib in Advanced Non-squamous NSCLC Patients With Uncleared Plasma ctDNA EGFRm After First-line Treatment With Gefitinib

NCT04358562 | Unknown Phase 2

• 1 other identifier: 20171BCD40022
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

TKIs therapy is the first-line treatment of patients with EGFR mutation advanced NSCLC.However, some patients have poor prognosis of drug resistance in the early stage. The dynamic alterations of ctDNA-based EGFR mutation after TKIs treatment is a predictor of the efficacy of TKIs treatment, which can be used to identify this part of patients in the early stage.Drug resistance can be overcome when TKIs is combined with drugs in different mechanisms of action, such as chemotherapy and anti-angiogenesis therapy.Gefitinib is the first-generation oral EGFR TKIs. Anlotinib is a domestic oral small molecule inhibitor of multireceptor tyrosine kinase, which has extensive inhibitory effect on tumor angiogenesis and growth.Gefitinib combined with anlotinib is a new option in the treatment of patients with uncleared plasma EGFRm after gefitinib treatment.

Conditions

Non-small Cell Lung Cancer; EGFR Gene Mutation

Keywords

Gefitinib; Anlotinib; EGFR Gene Mutation; Non-small Cell Lung Cancer; TKIs; Antivascular therapy

Outcome Measures

Primary Outcomes (1)

• progression-free survival, PFS

  The period from the start of treatment to the progression or death of a patient

  Every 6 weeks up to 2 years

Secondary Outcomes (3)

• overall survival, OS

  Every 6 weeks up to 2 years, and then every 3 months up to 5 years

• Objective Response Rate, ORR

  6 weeks after treatment

• adverse events

  Every 6 weeks up to 2 years

Study Arms (2)

Gefitinib with Anlotinib

EXPERIMENTAL

If persistence of plasma ctDNA EGFRm after 8 weeks of gefitinib first-line treatment, Gefitinib 250mg oral daily and Anlotinib 10mg oral d1-14, every 3 weeks

Drug: Gefitinib; Drug: Anlotinib

Gefitinib

EXPERIMENTAL

If clearance of plasma ctDNA EGFRm after 8 weeks of gefitinib first-line treatment, Gefitinib 250mg oral daily

Drug: Gefitinib

Interventions

Gefitinib DRUG

If persistence of plasma ctDNA EGFRm after 8 weeks of gefitinib first-line treatment

Also known as: Iressa

Gefitinib; Gefitinib with Anlotinib

Anlotinib DRUG

If clearance of plasma ctDNA EGFRm after 8 weeks of gefitinib first-line treatment

Also known as: AL3818

Gefitinib with Anlotinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed that EGFR sensitive mutation (ex19del or L858R mutation) in tumor tissue was detected by non-squamous NSCLC, and EGFR mutation (ex19del or L858R mutation) in ctDNA before treatment;
• Staging is IVB stage (AJCC 8th Edition) ;
• According to the comprehensive judgment of many disciplines, it is impossible to be treated by operation;
• PS score 0-1;
• The patient has at least one measurable tumor injury (the tumor is considered unmeasurable at the site of previous radiotherapy);
• Systemic anti-tumor therapy such as chemotherapy, immunotherapy and targeted therapy were not performed before entering the group;
• There is no history of malignant tumor and no serious medical disease;
• FEV1 ≥ 1.2L/ seconds or ≥ 50% predicted value;
• Laboratory examination: White blood cell count ≥ 4 \*10\^9/L, neutrophil count ≥ 2.0 \*10\^9, platelet count ≥ 100 \*10\^9, hemoglobin ≥ 10 g / L, liver and kidney function and ECG were normal;
• The pregnancy test was negative within 3 days before entering the group, and agreed to use medically effective contraceptive measures during the trial;
• Life expectancy is more than 12 weeks;
• Sign informed consent form; cooperate with regular follow-up.

You may not qualify if:

• T4 (AJCC 8th Edition) patients with severe destruction and stenosis of large vessels confirmed by imaging;
• Clinical severe infection (\> grade 2 NCI-CTC V3.0);
• Severe immunosuppressive disease;
• The patient's physical condition is life-threatening;
• A pregnant or breastfeeding patient. Female patients who are likely to become pregnant must be tested negative within 7 days of the start of treatment before continuing. Patients enrolled in the trial (both male and female) must use contraception during the trial period until two weeks after the trial is completed;
• PS score ≥ 2;
• At the same time, there are other serious diseases (congestive heart failure, transmural myocardial infarction, COPD or other respiratory diseases that affect treatment, etc.), considering that the study may aggravate or fail to control the disease;
• Those who have suffered or are currently suffering from tumors whose primary site or histology are different from those evaluated in this study. Excluding cervical carcinoma in situ, cured basal cell carcinoma, bladder surface tumor \[Ta,Tis\&T1\], or any cured tumor that has been in the study for more than 3 years;
• The patient refused to participate.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead
• Nanchang University: collaborator

Study Sites (1)

The Second Afiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib; anlotinib

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)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Liu Anwen, Phd

  Second Affiliated Hospital of Nanchang University

  STUDY DIRECTOR

Central Study Contacts

Liu Anwen, Phd

CONTACT

+8613767120022; awliu666@163.com

Wang Xia, Phd

CONTACT

+8618807070724; xiaoyaowangxia@163.com

Study Design

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

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: November 1, 2022
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)