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Report for Clinical Trial NCT04059874

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

To Assess the Safety and Efficacy of Third-line and Above Therapy of Patients With Local Advanced or Metastatic NSCLC With Combined Treatment With Launched Recombinant Humanized Anti-PD-1 Monoclonal Antibody and Donafenib Tosilate

To assess the safety and efficacy of third-line and above therapy of patients with local advanced or metastatic non-small cell lung cancer (NSCLC) with combined treatment with launched recombinant humanized anti-PD-1 monoclonal antibody and Donafenib Tosilate

NCT04059874 Non-small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: donafenib tablets

Description: donafenib tablets 100mg qd dose group and donafenib tablets 100mg bid dose group
Type: Drug
Group Labels: 2

donafenib tablets 1 donafenib tablets 2


Primary Outcomes

Description: safety assessments

Measure: safety assessments

Time: From signing ICF to 30 days after the end of treatment

Secondary Outcomes

Description: progression-free survival (PFS)

Measure: Effective evaluation

Time: Continue treatment until the end of treatment,an average of 12 months

Measure: Overall response rate

Time: Continue treatment until the end of treatment,an average of 12 months

Measure: Disease control rate

Time: Continue treatment until the end of treatment,an average of 12 months

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There is one SNP

SNPs


1 T790M

Chemotherapy treatments must include a two-drug regimen containing platinum, patients with EGFR TKI drug resistance and unknow T790M mutation, after AZD9291 treatment patients with T790M mutation could be enrolled 4, At least one measurable lesion as defined by RECIST 1.1. --- T790M ---

Chemotherapy treatments must include a two-drug regimen containing platinum, patients with EGFR TKI drug resistance and unknow T790M mutation, after AZD9291 treatment patients with T790M mutation could be enrolled 4, At least one measurable lesion as defined by RECIST 1.1. --- T790M --- --- T790M ---



HPO Nodes


HPO: