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

Advanced NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06356675
• Other study ID #: A single-arm pilot
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 1, 2024
• Est. completion date: July 1, 2028

Study information

• Verified date: April 2024
• Source: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
• Contact: linzhu zhai
• Phone: 02036492550
• Email: linzhuzhai[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 33
• Est. completion date: July 1, 2028
• Est. primary completion date: July 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced NSCLC
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Tislelizumab
200mg iv D1 Q3W
• Anlotinib
Anlotinib 12mg D1-12 Q3W

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	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
Secondary	over survival time	the time from initiation of treatment to death as assessed by the treating physicians in the study (investigator-assessed).	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
Secondary	disease control rate	assessment of tumor the rate of the tumor harvest control including CR.PR and SD	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	safety including any grade adverse events	The adverse event type and the proportion of AE during the progress of disease treatment	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