SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT03720873

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

An Multicenter,Phase II Trial of EGFR-TKIs Combine With Anlotinib as First-line Treatment for Patients With Advanced EGFR Mutation-positive NSCLC

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

NCT03720873 EGFR Gene Mutation

2 Interventions

Name: erlotinib or gefitinib or icotinib

Description: Patients will be treated with erlotinib 150mgQD or gefitinib250mgQD or icotinib 125 mg TID
Type: Drug
Group Labels: 1

EGFR-TKIs and Anlotinib

Name: Anlotinib

Description: Patients will be treated with Anlotinib 12mg po d1-14 Q21d
Type: Drug
Group Labels: 1

EGFR-TKIs and Anlotinib


Primary Outcomes

Description: Time from the date of enrolment to discontinuation of treatment for any reason (including progression of disease, treatment toxicity, refusal and death)

Measure: Progression free survival

Time: within 6 months of the last visit of last patient, approximately 30 months after inclusion of first patient

Secondary Outcomes

Description: 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.

Measure: Objective response

Time: through study completion,an average of three years

Description: Adverse events graded according to NCI CTCAE V4.03

Measure: Safety - Adverse events graded according to NCI CTCAE V4.03

Time: within 6 months of the last visit of last patient, approximately 30 months after inclusion of first patient

Description: Defined as the time in month from diagnosis of recurrent NPC to the date of death is observed or to last follow-up visit.

Measure: Overall survival

Time: Three years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 L858R

- 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. --- L858R ---



HPO Nodes