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

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

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: donafenib tablets

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

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The First Affiliated Hospital of College of Medicine Zhejiang University
      • Contact: Jianying Zhou, MD; Phone Number: 13505719970; Email: drzjy@163.com
      • Contact: Jianya Zhou, MD; Phone Number: 13858123060; Email: zhoujianya@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: donafenib tablets 1; This is the dose group was given once a day. donafenib tablets 1 100mg qd dose group	Drug: donafenib tablets; donafenib tablets 100mg qd dose group and donafenib tablets 100mg bid dose group
Experimental: donafenib tablets 2; This is the dose group was given twice a day. donafenib tablets 2 100mg bid dose group	Drug: donafenib tablets; donafenib tablets 100mg qd dose group and donafenib tablets 100mg bid dose group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety assessments	safety assessments	From signing ICF to 30 days after the end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective evaluation	progression-free survival (PFS)	Continue treatment until the end of treatment，an average of 12 months
Overall response rate		Continue treatment until the end of treatment，an average of 12 months
Disease control rate		Continue treatment until the end of treatment，an average of 12 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Investigators: Principal Investigator: Jianying Zhou, MD, First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2019
• Primary Completion (Anticipated): July 31, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: August 5, 2019
• First Submitted That Met QC Criteria: August 15, 2019
• First Posted (Actual): August 16, 2019

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: ZGDLH001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share date of the trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No