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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06356675
Other study ID # A single-arm pilot
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date July 1, 2024
Est. completion date July 1, 2028

Study information

Verified date April 2024
Source The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Contact linzhu zhai
Phone 02036492550
Email linzhuzhai@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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怂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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 33
Est. completion date July 1, 2028
Est. primary completion date July 1, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tislelizumab
200mg iv D1 Q3W
Anlotinib
Anlotinib 12mg D1-12 Q3W

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Outcome

Type Measure Description Time frame Safety issue
Primary objective response rate The rate of tumor shrinkage reached 30% at least .including part reponse and complete response 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
Secondary progression free survival time the time from initiation of treatment to disease progression or death as assessed by the treating physicians in the study (investigator-assessed). 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
Secondary over survival time the time from initiation of treatment to death as assessed by the treating physicians in the study (investigator-assessed). 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
Secondary disease control rate assessment of tumor the rate of the tumor harvest control including CR.PR and SD 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
Secondary safety including any grade adverse events The adverse event type and the proportion of AE during the progress of disease treatment 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
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