An Multicenter,Phase II Trial of EGFR-TKIs Combine With Anlotinib as First-line Treatment for Patients With Advanced EGFR Mutation-positive NSCLC
Overview
- Phase
- Phase 2
- Intervention
- erlotinib or gefitinib or icotinib
- Conditions
- EGFR Gene Mutation
- Sponsor
- Fujian Cancer Hospital
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Progression free survival
- Last Updated
- 7 years ago
Overview
Brief Summary
A single arm study: EGFR-TKIs Combine With Anlotinib as First-line Treatment in patients with EGFR-mutant non-small-cell lung cancer (NSCLC).
Detailed Description
This trial investigated the efficacy and safety of EGFR-TKIs Combine With Anlotinib as First-line Treatment in patients with EGFR-mutant NSCLC.
Investigators
Eligibility Criteria
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
Arms & Interventions
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
Intervention: erlotinib or gefitinib or icotinib
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
Intervention: Anlotinib
Outcomes
Primary Outcomes
Progression free survival
Time Frame: within 6 months of the last visit of last patient, approximately 30 months after inclusion of first patient
Time from the date of enrolment to discontinuation of treatment for any reason (including progression of disease, treatment toxicity, refusal and death)
Secondary Outcomes
- Overall survival(Three years)
- Objective response(through study completion,an average of three years)
- Safety - Adverse events graded according to NCI CTCAE V4.03(within 6 months of the last visit of last patient, approximately 30 months after inclusion of first patient)