Clinical trial NCT06356675: A Single-arm Pilot Study of Tislelizumab Combined With Anlotinib in Patients With Advanced NSCLC With Driver-negative After Progression to Immunotherapy
Official title: A Single-arm Pilot Study of Tislelizumab Combined With Anlotinib in Patients With Advanced NSCLC With Driver-negative After Progression to Immunotherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Advanced NSCLC
Keywords: Progress in first-line immunotherapy
Lead sponsor: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: objective response rate
timeFrame: 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 outcomes:
measure: progression free survival time
timeFrame: 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
measure: over survival time
timeFrame: 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
measure: disease control rate
timeFrame: 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
measure: safety including any grade adverse events
timeFrame: 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
Other outcomes:
Locations:
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