Advanced lung adenocarcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years old; 2. Patients with advanced lung adenocarcinoma (stage IIIB-IV) confirmed by histopathology or cytology; 3. According to RECIST v1.1 standard, patients with measurable target lesions by CT or MRI examination. The imaging evaluation was performed within 28 days before the first administration; 4. Patients who have relapsed or failed to receive platinum based dual drug combination chemotherapy. The definition of "treatment failure": disease progression during treatment or after the last treatment must have clear evidence of imaging or clinical progress. 5. Patients with negative EGFR, ALK and ros1 mutations; 6. ECoG PS score: 0-1; 7. Patients who volunteered to join the study signed informed consent and had good compliance, and cooperated with follow-up; 8. The researchers believe that patients can benefit.
Exclusion criteria
Exclusion criteria: 1. Excluding patients without measurable lesions; 2. Patients who have been proved to be allergic to the test drug and / or its excipients; 3. Patients with brain metastasis or meningeal metastasis with clinical symptoms. Patients with brain metastases after treatment need to meet the following conditions: no progress demonstrated by MRI at least 4 weeks after the end of treatment, treatment completed within 28 days before the first dose of study drug, and no systemic corticosteroid therapy (> 10mg / day prednisone or equivalent dose) was required before = 14 days before the first dose of study drug; 4. Patients with interstitial pneumonia (ILD), drug-induced pneumonia, radiation-induced pneumonia requiring steroid therapy, or active pneumonia with clinical symptoms or severe pulmonary dysfunction; 5. Patients with heart clinical symptoms or diseases that are not well controlled, such as: (1) NYHA grade 2 and above heart failure (2) Unstable angina pectoris (3) Myocardial infarction occurred within 24 weeks (4) Clinically significant supraventricular or ventricular arrhythmias need treatment or intervention; 6. Patients who have previously received any T-cell costimulation or immune checkpoint therapy, including but not limited to cytotoxic T lymphocyte associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1 / 2 inhibitors, or other drugs targeting T cells; 7. Patients with any immunodeficiency disease or history, or with a history of organ transplantation; 8. Pregnant or lactating women; 9. According to the judgment of the researcher, the patients who are not suitable to be included in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Desease control rate;Duration of remission;Adverse event; | — |
Countries
China
Contacts
The First Affiliated Hospital of University of Science and Technology of China