A Single-arm Pilot Study of Tislelizumab Combined With Anlotinib in Patients With Advanced NSCLC With Driver-negative After Progression to Immunotherapy

Phase 4Not Yet RecruitingNCT06356675

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine33 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced NSCLC

Interventions

TislelizumabDRUG

200mg iv D1 Q3W

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

objective response rate

The rate of tumor shrinkage reached 30% at least .including part reponse and complete response

Time frame: 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

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).

Time frame: 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

over survival time

the time from initiation of treatment to death as assessed by the treating physicians in the study (investigator-assessed).

Time frame: 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

disease control rate

assessment of tumor the rate of the tumor harvest control including CR.PR and SD

Time frame: 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

safety including any grade adverse events

The adverse event type and the proportion of AE during the progress of disease treatment

Time frame: 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