NCT04059874

Treatment of Non-small Cell Lung Cancer With PD-1 Monoclonal Antibody Combined With Donafenib Toluene Sulfonate

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Donafenib has a multi-target and dual anti-tumor effect, similar to sorafenib toluene sulfonate, and its effect is similar to that of sorafenib toluene sulfonate. Donafenib has the potential to be effective in the treatment of cancer, including advanced non-small cell lung cancer. PD-1 inhibitor has become a new therapy for advanced non-small cell lung cancer because of its strong specificity, definite efficacy, small side effects and long time of tumor control. This is a single-center, open, single-arm, exploratory phase Ib trial. There were two dosages of donafenib (100mg qd and 100mg bid, respectively). Three to six subjects were enrolled in the dosages of 100mg qd. The investigators determined that the dosages of 100mg bid were well tolerated

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	donafenib tablets	donafenib tablets 100mg qd dose group and donafenib tablets 100mg bid dose group

Timeline

• Start date: 2019-07-31
• Primary completion: 2020-07-31
• Completion: 2020-11-30
• First posted: 2019-08-16
• Last updated: 2019-08-16

Locations

1 site across 1 country: China