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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04059874
• Other study ID #: ZGDLH001
• Status: Recruiting
• Phase: Phase 1
• Start date: July 31, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: August 2019
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Jianying Zhou, MD
• Phone: 13505719970
• Email: drzjy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 30, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1?18 years age or older ,male or female

2?Histologically or cytologically confirmed diagnosis of local advanced or metastatic NSCLC

3?Previously received with two or more systemic Antitumor treatments (Chemotherapy or targeted therapy). 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. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation

5?Asymptomatic patients with uncontrolled brain metastases or brain metastases involving the pia mater

6?Patients must have recovered from all toxicities related to prior anticancer therapies to = 2 (CTCAE v5.0). AE of Neurology must be = 1

7?Life expectancy = 12 weeks

8?ECOG performance status 0-1

Exclusion Criteria:

1. Small cell lung cancer (including small lung cancer mixed with non-small cell lung cancer)

2. Patients at risk of bleeding treated with antiangiogenic drugs

3. Subjects who are using immunosuppressive agents, or systemic, or absorbable topical hormone therapy for immunosuppressive purposes (dose >10mg/ dprednisone or other therapeutic hormones) and who continue to use it for 2 weeks prior to enrollment

4. Patients with active, known or suspected autoimmune diseases, including tuberculosis, HIV infection, active hepatitis, etc.

5. Patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, severe impairment of lung function, etc

6. Women who are pregnant or lactating, or who are unwilling to use contraception during the trial

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• donafenib tablets
donafenib tablets 100mg qd dose group and donafenib tablets 100mg bid dose group

Locations

Country	Name	City	State
China	The First Affiliated Hospital of College of Medicine Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety assessments	safety assessments	From signing ICF to 30 days after the end of treatment
Secondary	Effective evaluation	progression-free survival (PFS)	Continue treatment until the end of treatment,an average of 12 months
Secondary	Overall response rate		Continue treatment until the end of treatment,an average of 12 months
Secondary	Disease control rate		Continue treatment until the end of treatment,an average of 12 months