EGFR Gene Mutation
Conditions
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.
Interventions
DRUGerlotinib or gefitinib or icotinib
Patients will be treated with erlotinib 150mgQD or gefitinib250mgQD or icotinib 125 mg TID
DRUGAnlotinib
Patients will be treated with Anlotinib 12mg po d1-14 Q21d
Sponsors
Fujian Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Objective response | through study completion,an average of three years | Best overall response (complete remission or partial remission) across all assessment time-points according to RECIST Criteria 1.1, during the period from enrolment to termination of trial treatment. |
| 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 | Adverse events graded according to NCI CTCAE V4.03 |
| Overall survival | Three years | Defined as the time in month from diagnosis of recurrent NPC to the date of death is observed or to last follow-up visit. |
Countries
China
Contacts
Primary ContactZhiyong He, master
Outcome results
None listed