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

NCT04059874 | Unknown Phase 1

• 1 other identifier: ZGDLH001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Non-small Cell Lung Cancer

Keywords

non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• safety assessments

  safety assessments

  From signing ICF to 30 days after the end of treatment

Secondary Outcomes (3)

• Effective evaluation

  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

Study Arms (2)

donafenib tablets 1

EXPERIMENTAL

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

Drug: donafenib tablets

donafenib tablets 2

EXPERIMENTAL

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

Drug: donafenib tablets

Interventions

donafenib tablets DRUG

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

donafenib tablets 1; donafenib tablets 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 、18 years age or older ,male or female
• 、Histologically or cytologically confirmed diagnosis of local advanced or metastatic NSCLC
• 、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
• 、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
• 、Asymptomatic patients with uncontrolled brain metastases or brain metastases involving the pia mater
• 、Patients must have recovered from all toxicities related to prior anticancer therapies to ≤ 2 (CTCAE v5.0). AE of Neurology must be ≤ 1
• 、Life expectancy ≥ 12 weeks
• 、ECOG performance status 0-1

You may not qualify if:

• Small cell lung cancer (including small lung cancer mixed with non-small cell lung cancer)
• Patients at risk of bleeding treated with antiangiogenic drugs
• 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
• Patients with active, known or suspected autoimmune diseases, including tuberculosis, HIV infection, active hepatitis, etc.
• Patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, severe impairment of lung function, etc
• Women who are pregnant or lactating, or who are unwilling to use contraception during the trial

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital of College of Medicine Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

donafenib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jianying Zhou, MD

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianying Zhou, MD

CONTACT

13505719970; drzjy@163.com

Jianya Zhou, MD

CONTACT

13858123060; zhoujianya@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Model Details: This is a single-center, open, single-arm, exploratory phase Ib trial

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 16, 2019
• Study Start: July 31, 2019
• Primary Completion: July 31, 2020
• Study Completion: November 30, 2020
• Last Updated: August 16, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)