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

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2028-07-01

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.

Conditions

Advanced NSCLC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment group

Tislelizumab 200mg iv D1+anlotinib(12mg D1-12)

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

200mg iv D1 Q3W

Anlotinib

Intervention Type: DRUG

Anlotinib 12mg D1-12 Q3W

Interventions

Tislelizumab

200mg iv D1 Q3W

Intervention Type: DRUG

Anlotinib

Anlotinib 12mg D1-12 Q3W

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Linzhu Zhai

professor of medicine，Deputy Director of Department of Radiotherapy, Oncology Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

linzhu zhai

Role: CONTACT

linzhuzhai@163.com

02036492550

Other Identifiers

A single-arm pilot

Identifier Type: -

Identifier Source: org_study_id