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Report for Clinical Trial NCT03792074

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

to Evaluate SCT510 Compared to Avasitin Respectively Combined Paclitaxel and Carboplatin First-line Treatment of Locally Advanced and Metastatic or Recurrent Squamous Cell Non-small Cell Lung Cancer Efficacy and Safety

To evaluate the safety, efficacy and immunogenicity of SCT510 combined with paclitaxel and carboplatin compared with bevacizumab combined with paclitaxel and carboplatin in the first-line treatment of locally advanced metastatic or recurrent squamous cell non-small cell lung cancer.

NCT03792074 Non-squamous Cell Non-small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

4 Interventions

Name: SCT510

Description: SCT510 Injection
Type: Drug
Group Labels: 1

SCT510 combined paclitaxel and carboplatin

Name: Bevacizumab

Description: Bevacizumab Injection
Type: Drug
Group Labels: 1

Bevacizumab combined paclitaxel and carboplatin

Name: Paclitaxel

Description: Paclitaxel Injection
Type: Drug
Group Labels: 2

Bevacizumab combined paclitaxel and carboplatin SCT510 combined paclitaxel and carboplatin

Name: Carboplatin

Description: Carboplatin injection
Type: Drug
Group Labels: 2

Bevacizumab combined paclitaxel and carboplatin SCT510 combined paclitaxel and carboplatin


Primary Outcomes

Description: the proportion of subjects whose CR(complete response) and PR(partial response)combined , according to RECIST 1.1 criteria

Measure: Objective response rate

Time: 12 weeks

Secondary Outcomes

Description: the proportion of subjects whose CR(complete response) and PR(partial response)combined , according to RECIST 1.1 criteria

Measure: Objective response rate

Time: 18 week

Description: the proportion of subjects with CR(complete response), PR(partial response) and SD(Stable disease) combined,according to RECIST 1.1 criteria

Measure: Disease control rate

Time: 12 weeks and 18 weeks

Description: The time from the first assessment of CR(complete response) or PR(partial response) to the first assessment of PD(progressive disease) or any cause of death,according to RECIST 1.1 criteria

Measure: Duration of Response

Time: 3 years

Description: The time from randomization to PD(progressive disease) or any cause of death,according to RECIST 1.1 criteria

Measure: Progression free survival

Time: 3 years

Description: The proportion of subjects who survived longer than 1 year after randomization

Measure: 1-year overall survival rate

Time: 1 year

Description: Defined as the time from randomization of subjects to death from any cause

Measure: Overall survival

Time: 3 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 L858R

21 (L858R, L861Q)) and ALK fusion.Subjects who have not previously undergone EGFR and ALK gene testing will need to undergo genetic testing during the screening period.Among them, subjects whose EGFR or ALK gene status cannot be determined for various reasons can be enrolled;Subjects who are known to have EGFR sensitive mutations and/or ALK fusion may also be enrolled if they are currently unable to obtain the corresponding targeted drugs (including the rejection of the subjects) and chemotherapy is standard treatment at the research center; 5. --- L858R ---


2 L861Q

21 (L858R, L861Q)) and ALK fusion.Subjects who have not previously undergone EGFR and ALK gene testing will need to undergo genetic testing during the screening period.Among them, subjects whose EGFR or ALK gene status cannot be determined for various reasons can be enrolled;Subjects who are known to have EGFR sensitive mutations and/or ALK fusion may also be enrolled if they are currently unable to obtain the corresponding targeted drugs (including the rejection of the subjects) and chemotherapy is standard treatment at the research center; 5. --- L858R --- --- L861Q ---



HPO Nodes


HPO: