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NCT Number: NCT06356675

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

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.

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Key information

Conditions

Advanced NSCLC

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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

Treatment and study plan

Tislelizumab

Drug

200mg iv D1 Q3W

Anlotinib

Drug

Anlotinib 12mg D1-12 Q3W

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

  2. 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).

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

linzhu zhai

CONTACT

[email protected]

02036492550

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 10, 2024
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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