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

NCT ID: NCT04059874

Last Updated: 2019-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2020-11-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

donafenib tablets 1

This is the dose group was given once a day. donafenib tablets 1 100mg qd dose group

Group Type: EXPERIMENTAL

donafenib tablets

Intervention Type: DRUG

donafenib tablets 100mg qd dose group and donafenib tablets 100mg bid dose group

donafenib tablets 2

This is the dose group was given twice a day. donafenib tablets 2 100mg bid dose group

Group Type: EXPERIMENTAL

donafenib tablets

Intervention Type: DRUG

donafenib tablets 100mg qd dose group and donafenib tablets 100mg bid dose group

Interventions

donafenib tablets

donafenib tablets 100mg qd dose group and donafenib tablets 100mg bid dose group

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Zhou Jianying

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianying Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Locations

The First Affiliated Hospital of College of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianying Zhou, MD

Role: CONTACT

drzjy@163.com

13505719970

Jianya Zhou, MD

Role: CONTACT

zhoujianya@hotmail.com

13858123060

Facility Contacts

Jianying Zhou, MD

Role: primary

drzjy@163.com

13505719970

Jianya Zhou, MD

Role: backup

zhoujianya@hotmail.com

13858123060

Other Identifiers

ZGDLH001

Identifier Type: -

Identifier Source: org_study_id