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

• Status: Unknown status
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Zhejiang University
• Treatments: Antibodies; Antibodies, Monoclonal

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