Advanced non-squamous non-small cell lung cancer (NSCLC) with negative driver genes that has developed secondary resistance after first-line treatment with a combination of PD-1/L1 inhibitors and a platinum-based doublet regimen.
Conditions
Interventions
Sponsors
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the clinical study; fully understand and be informed about this study and sign the Informed Consent Form (ICF); be willing to comply with and have the ability to complete all the procedures of the trial; 2. The age should be between 18 and 75 years old (including the boundary values), regardless of gender. 3. Locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with negative driver genes, which has been pathologically confirmed to be inoperable or unsuitable for radical radiotherapy. 4. Patients who have developed secondary resistance after receiving first-line treatment with a combination regimen of a PD-1/L1 inhibitor and a platinum-containing doublet drug. 5. There must be an interval of at least 4 weeks from the end of the previous systemic anti-tumor treatment to the start of the study drug administration. And the treatment-related adverse events (AEs) should have recovered to a grade = 6 months. 9. The main organ functions are good, that is, they meet the following criteria, and within 14 days before the first administration of the drug in this study, the patient has not received blood transfusion, albumin, recombinant human thrombopoietin or colony-stimulating factor (CSF) treatment. 10. All clinical data are complete.
Exclusion criteria
Exclusion criteria: 1. Patients with primary resistance who progress within 2 to 4 cycles of treatment with a combination of a PD-1/L1 inhibitor and a platinum-containing regimen during the first-line treatment. 2. Patients who received chemotherapy with nab-paclitaxel or taxane drugs during the first-line treatment. 3. Patients who received other immunotherapeutic drugs (such as CTLA-4 inhibitors, etc.) during the first-line treatment. 4. Patients who used macromolecular monoclonal antibodies with anti-angiogenic effects such as bevacizumab, or small-molecule tyrosine kinase inhibitor (TKI) drugs for other anti-angiogenic treatments, such as anlotinib, lenvatinib, etc., during the first-line treatment. 5. Patients whose tumors are close to major blood vessels and have a high tendency to bleed; patients with any signs of bleeding or a history of bleeding, and those judged by the investigator to be likely to be affected in terms of treatment; patients who have experienced any bleeding event of >= grade 3 according to CTCAE within 4 weeks before the first administration of the study drug, and those with unhealed wounds, ulcers or fractures. 6. Hemoptysis > 50 ml per day; 7. Poorly controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg); 8. Patients with known other malignant tumors that are developing or require active treatment. 9. Patients who are currently participating in or have participated in a clinical study of other drugs. 10. Having interstitial lung disease or (non-infectious) pneumonia that requires treatment with steroid medications. 11. Known to have a mental disorder or a substance abuse disorder that may interfere with cooperation with the requirements of the trial. 12. From the screening visit until 120 days after treatment, being pregnant or breastfeeding during the planned duration of the trial, or expecting to become pregnant or give birth. 13. The investigator deems that the subject has any clinical or laboratory abnormalities or compliance issues that make it inappropriate for the subject to participate in this clinical study. 14. Any condition that requires systemic treatment with corticosteroids (at a dose higher than 10 mg of prednisone per day or an equivalent dose of similar medications) or treatment with other immunosuppressive agents within <= 14 days before enrollment; Note: Patients who are currently using or have previously used any of the following steroid regimens may be eligible for inclusion: a) Adrenal replacement steroids (prednisone <= 10 mg per day or an equivalent dose of similar medications); b) Topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids with minimal systemic absorption; c) Short-term (<= 7 days) prophylactic use of corticosteroids (e.g., for contrast media allergy) or use for the treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reactions caused by contact allergens). 15. Meeting any of the following cardiovascular disease criteria: a) Cardiac chest pain occurring within <= 28 days before enrollment, defined as moderate pain that restricts functional activities in daily life; b) Symptomatic pulmonary embolism having occurred within <= 28 days before enrollment; c) Acute myocardial infarction having occurred within <= 6 months before enrollment, and having a history of any heart failure reaching New York Heart Association class III or IV within <= 6 months before enrollment; d) Ventricular arrhythmi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;Overall Survival(OS);Duration of Response(DOR);Progression-Free Survival(PFS);Disease Control Rate (DCR); | — |
Countries
China
Contacts
Public ContactLinliping
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Outcome results
None listed