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Report for Clinical Trial NCT03671538

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized Phase II Study of Anlotinib Combined With Pemetrexed and Cisplatin in First Treatment for Advanced Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Negative Mutations

Chemotherapy is still the standard first-line treatment option for EGFR unmutated patients. After a randomized phase Ⅲ trial, BEYOND was presented the synergistic effect of progression-free survival(PFS) could be expected when chemotherapy is combined with Antiangiogenesis agent bevacizumab in China;Therefore,in this study, The investigators will investigate the efficacy and safety of Anlotinb combined With Pemetrexed and Cisplatin as first-line therapy in patients with chemotherapy-naive, stage IIIB or IV, non-squamous NSCLC without targetable EGFR or ALK genetic aberrations.

NCT03671538 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

3 Interventions

Name: Anlotinib

Description: Anlotinib 12mg qd on day 1 to 14 of a 21-day cycle
Type: Drug
Group Labels: 1

Anlotinib Plus Pemetrexed and Cisplatin

Name: pemetrexed

Description: pemetrexed 500mg/m2 on day 1 of a 21-day cycle ;
Type: Drug
Group Labels: 1

Anlotinib Plus Pemetrexed and Cisplatin

Name: Cisplatin

Description: Cisplatin 75mg/m2 on day 1 of a 21-day cycle ;
Type: Drug
Group Labels: 1

Anlotinib Plus Pemetrexed and Cisplatin


Primary Outcomes

Description: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first

Measure: progression-free survival

Time: From enrollment to completion of study. Estimated about 24 months.

Secondary Outcomes

Description: Clinical response of treatment according to RESIST v1.1 criteria (ORR, Overall Response Rate)

Measure: Overall Response Rate

Time: From enrollment to progression of disease. Estimated about 24 months

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

Measure: disease control rate

Time: From enrollment to progression of disease. Estimated about 24 months

Description: From date of randomization until the date of death or date of last visit/contact, whichever came first

Measure: Overall Survival

Time: From enrollment to completion of study. Estimated about 24 months.

Description: Proportion of people who first documented disease progression or death from any cause, whichever came first ,during 6 months

Measure: 6-month PFS rate

Time: From enrollment to analysis, Estimated about 6 months

Description: Proportion of people who first documented disease progression or death from any cause, whichever came first ,during 12 months

Measure: 12-month PFS rate

Time: From enrollment to analysis. Estimated about 12 months.

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 2 SNPs

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) - Patients have not been received systematic treatment,including chemotherapy and EGFR-TKIs - EGFR mutations confirmed by molecular detection (including, but not limited to, T790M, 19 exon deletion and L858R) external pathological examination was accepted (including pathological or blood test results) - 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. --- T790M --- --- L858R ---


2 T790M

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) - Patients have not been received systematic treatment,including chemotherapy and EGFR-TKIs - EGFR mutations confirmed by molecular detection (including, but not limited to, T790M, 19 exon deletion and L858R) external pathological examination was accepted (including pathological or blood test results) - 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. --- T790M ---



HPO Nodes


HPO: