To hear about similar clinical trials, please enter your email below
Trial Title:
A Single-arm Pilot Study of Tislelizumab Combined With Anlotinib in Patients With Advanced NSCLC With Driver-negative After Progression to Immunotherapy
NCT ID:
NCT06356675
Condition:
Advanced NSCLC
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Tislelizumab
Conditions: Keywords:
Progress in first-line immunotherapy
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
200mg iv D1 Q3W
Arm group label:
treatment group
Intervention type:
Drug
Intervention name:
Anlotinib
Description:
Anlotinib 12mg D1-12 Q3W
Arm group label:
treatment group
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
July 1, 2024
Completion date:
July 1, 2028
Lead sponsor:
Agency:
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Agency class:
Other
Source:
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06356675
