Status:
UNKNOWN
Treatment of Non-small Cell Lung Cancer With PD-1 Monoclonal Antibody Combined With Donafenib Toluene Sulfonate
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 hum...
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 eff...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04059874
Start Date
July 31 2019
End Date
November 30 2020
Last Update
August 16 2019
Active Locations (1)
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1
The First Affiliated Hospital of College of Medicine Zhejiang University
Hangzhou, Zhejiang, China, 310000