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
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
donafenib tablets 100mg qd dose group and donafenib tablets 100mg bid dose group
The First Affiliated Hospital of College of Medicine Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGsafety assessments
safety assessments
Time frame: From signing ICF to 30 days after the end of treatment
Effective evaluation
progression-free survival (PFS)
Time frame: Continue treatment until the end of treatment,an average of 12 months
Overall response rate
Time frame: Continue treatment until the end of treatment,an average of 12 months
Disease control rate
Time frame: Continue treatment until the end of treatment,an average of 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.