EGFR-TKIs Combine With Anlotinib as First-line Treatment for Patients With Advanced EGFR Mutation-positive NSCLC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-31

Study Completion Date

2022-09-30

Brief Summary

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A single arm study: EGFR-TKIs Combine With Anlotinib as First-line Treatment in patients with EGFR-mutant non-small-cell lung cancer (NSCLC).

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Detailed Description

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This trial investigated the efficacy and safety of EGFR-TKIs Combine With Anlotinib as First-line Treatment in patients with EGFR-mutant NSCLC.

Conditions

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EGFR Gene Mutation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EGFR-TKIs and Anlotinib

Experimental:EGFR-TKIs and Anlotinib EGFR-TKIs:erlotinib 150mg QD or gefitinib250mgQD or icotinib 125 mg TID , Anlotinib 12mg po qd d1-14 q21d

Group Type EXPERIMENTAL

erlotinib or gefitinib or icotinib

Intervention Type DRUG

Patients will be treated with erlotinib 150mgQD or gefitinib250mgQD or icotinib 125 mg TID

Anlotinib

Intervention Type DRUG

Patients will be treated with Anlotinib 12mg po d1-14 Q21d

Interventions

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erlotinib or gefitinib or icotinib

Patients will be treated with erlotinib 150mgQD or gefitinib250mgQD or icotinib 125 mg TID

Intervention Type DRUG

Anlotinib

Patients will be treated with Anlotinib 12mg po d1-14 Q21d

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* \- Age ≥ 18 years
* ECOG performance status 0-1
* Adequate haematological function, coagulation, liver function and renal function
* Pathological diagnosis of predominantly non-squamous, non-small-cell lung cancer (NSCLC)
* TNM version 7 stage IV disease including M1a (malignant effusion) or M1b (distant metastasis), or locally advanced disease not amenable to curative treatment (including patients progressing after radiochemotherapy for stage III disease)
* Measurable or evaluable disease (according to RECIST 1.1 criteria).
* Centrally confirmed EGFR exon 19 deletion (del19) or exon 21 mutation (L858R)

Exclusion Criteria

* \- Patients who have had in the past 5 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ breast carcinoma.

Patients with any known significant ophthalmologic anomaly of the ocular surface

* Patients who received prior chemotherapy for metastatic disease
* CNS metastases
* Patients who received previous treatment for lung cancer with drugs targeting EGFR or VEGF
* Pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No