Advanced NSCLC
Conditions
Keywords
Progress in first-line immunotherapy
Brief summary
Immune resistance after treatment, there is no standard treatment, one of the most important and the most effective measures is immune to combination therapy。Targeted angiogenesis therapy has always been the focus of research on the treatment of NSCLC patients with progressive disease after immunotherapy. From the mechanism of action, angiogenesis and immunosuppression are interrelated processes.
Interventions
DRUGTislelizumab
200mg iv D1 Q3W
DRUGAnlotinib
Anlotinib 12mg D1-12 Q3W
Sponsors
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. voluntary participation in clinical research; Fully understand and Informed the study and sign the Informed Consent Form (ICF); Be willing to follow and be able to complete all trial procedures; 2. age of 18-75 years old (including boundary value), regardless of gender; 3. Pathologically confirmed locally advanced, metastatic non-small cell lung cancer (NSCLC), including squamous non-small cell lung cancer and non-squamous non-small cell lung cancer. Patients with non-squamous non-small cell lung cancer should exclude known EGFR mutation or ALK gene rearrangement. 4. patients with resistance to first-line PD-(L)1 inhibitors combined with chemotherapy; 5. patients with tumor response of CR/PR/SD after at least one first-line immunotherapy; 6. Subjects' ECOG PS score was 0-1 (including boundary value); 7. Patients had to have ≥1 measurable lesion (according to RECIST1.1 criteria). 8. predicted survival time ≥6 months;
Exclusion criteria
1. Frontline treatment with anlotinib, anti-angiogenic macromolecular monoclonal antibody or other small molecule TKI drugs; 2. central lung cancer with large blood vessel invasion; 3. patients with any signs or history of bleeding that may affect treatment according to the investigator's judgment; Patients with bleeding events ≥CTCAE grade 3, unhealed wounds, ulcers, or fractures within 4 weeks before the first dose of study drug; 4. hemoptysis \> 50ml/d; 5. inability to swallow capsules or diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, gastric or small bowel resection, bariatric surgery, inflammatory bowel disease, partial or complete intestinal obstruction; 6. Poorly controlled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg) 7. other known malignant tumors that are developing or require active treatment; 8. Currently participating or has participated in the clinical research of other drugs; 9. interstitial lung disease or (non-infectious) pneumonia requiring steroid therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months | The rate of tumor shrinkage reached 30% at least .including part reponse and complete response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival time | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months | the time from initiation of treatment to disease progression or death as assessed by the treating physicians in the study (investigator-assessed). |
| over survival time | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to18 months | the time from initiation of treatment to death as assessed by the treating physicians in the study (investigator-assessed). |
| disease control rate | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months | assessment of tumor the rate of the tumor harvest control including CR.PR and SD |
| safety including any grade adverse events | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months | The adverse event type and the proportion of AE during the progress of disease treatment |
Contacts
Primary Contactlinzhu zhai
Outcome results
None listed