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Report for Clinical Trial NCT03602027

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Dose Climbing Trial of Anlotinib Plus Gefitinib in the First-line Treatment of Advanced Gene Positive Non-squamous Non-small Cell Lung Cancer

The purpose of this clinical study is to evaluate the tolerability and toxicity of different dose of Anlotinib puls Gefitinib in First-line Treatment of Advanced Gene Positive Non-squamous Non-small Cell Lung Cancer , to provide a reference of dosage for Phase II clinical trials

NCT03602027 Non-squamous Non-small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: Anlotinib

Description: Anlotinib 8mg p.o. qd in low-dose groups (3 subjects). 10mg p.o. qd in middle-dose groups (3 subjects). 12mg p.o. qd in high-dose groups (3 subjects).
Type: Drug
Group Labels: 1

Anlotinib Plus Gefitinib

Name: Gefitinib

Description: Gefitinib 250mg orally daily for three weeks
Type: Drug
Group Labels: 1

Anlotinib Plus Gefitinib


Primary Outcomes

Description: Dose Limiting Toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity according to NCI CTCAE 4.03 criteria

Measure: Dose limiting toxicity

Time: From enrollment to completion of study. Estimated about 4 months.

Description: Maximum Tolerance Dose (MTD) is the dose of treatment in the cohort where there are 2 cases of DLT reported.

Measure: Maximum tolerance dose

Time: From enrollment to completion of study. Estimated about 4 months

Secondary Outcomes

Description: Clinical response of treatment according to RESIST v1.1 criteria (DCR, disease control rate)

Measure: disease control rate

Time: From enrollment to 2 months after treatment

Description: The length of time from enrollment until the time of progression of disease (TTP, time to progression).

Measure: time to progression

Time: From enrollment to progression of disease. Estimated about 6 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 L858R

recurrent patients, adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant were assessed for eligibility, and the last treatment time must be more than 6 months before enrollment) - Epidermal Growth Factor Receptor(EGFR)mutations confirmed by molecular detection (including, but not limited to, 20 exon, 19 exon deletion and L858R) external pathological examination was accepted (including pathological or blood test results) - Patients have not been received systematic treatment,including chemotherapy and EGFR -TKIs(Tyrosine kinase inhibitors) - There were at least one target lesions in the past three months has not yet accepted radiotherapy, and could be recorded by magnetic resonance imaging (MRI) or computer tomography (CT) measuring accurately at least in one direction(The maximum diameter needs to be recorded), including conventional CT ≥20 mm or spiral CT ≥10 mm. - Life expectancy ≥3 months. --- L858R ---



HPO Nodes


HPO: