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

NCT06356675 | Not Yet Recruiting Phase 4

• 1 other identifier: A single-arm pilot
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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

Keywords

Progress in first-line immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• progression free survival time

  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

  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

  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

  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

Study Arms (1)

treatment group

EXPERIMENTAL

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

Drug: Tislelizumab; Drug: Anlotinib

Interventions

Tislelizumab DRUG

200mg iv D1 Q3W

treatment group

Anlotinib DRUG

Anlotinib 12mg D1-12 Q3W

treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• age of 18-75 years old (including boundary value), regardless of gender;
• 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.
• patients with resistance to first-line PD-(L)1 inhibitors combined with chemotherapy;
• patients with tumor response of CR/PR/SD after at least one first-line immunotherapy;
• Subjects' ECOG PS score was 0-1 (including boundary value);
• Patients had to have ≥1 measurable lesion (according to RECIST1.1 criteria).
• predicted survival time ≥6 months;

You may not qualify if:

• Frontline treatment with anlotinib, anti-angiogenic macromolecular monoclonal antibody or other small molecule TKI drugs;
• central lung cancer with large blood vessel invasion;
• 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;
• hemoptysis \> 50ml/d;
• 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;
• Poorly controlled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg)
• other known malignant tumors that are developing or require active treatment;
• Currently participating or has participated in the clinical research of other drugs;
• interstitial lung disease or (non-infectious) pneumonia requiring steroid therapy

Sponsors & Collaborators

• The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine: lead

MeSH Terms

Interventions

tislelizumab; anlotinib

Central Study Contacts

linzhu zhai

CONTACT

02036492550; linzhuzhai@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of medicine，Deputy Director of Department of Radiotherapy, Oncology Center

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 10, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 10, 2024

Record last verified: 2024-04