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

April 7, 2024 updated by: Linzhu Zhai, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

33

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group
Tislelizumab 200mg iv D1+anlotinib(12mg D1-12)
Drug: Tislelizumab
200mg iv D1 Q3W
Drug: Anlotinib
Anlotinib 12mg D1-12 Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival time
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
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
over survival time
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
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
disease control rate
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
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
safety including any grade adverse events
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

April 7, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 7, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A single-arm pilot

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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