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

ConditionAdvanced NSCLC
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab

    Drug

    200mg iv D1 Q3W

  • Anlotinib

    Drug

    Anlotinib 12mg D1-12 Q3W

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: treatment groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

objective response rate

The rate of tumor shrinkage reached 30% at least .including part reponse and complete response

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

Secondary outcomes

1

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).

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
2

over survival time

the time from initiation of treatment to death as assessed by the treating physicians in the study (investigator-assessed).

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
3

disease control rate

assessment of tumor the rate of the tumor harvest control including CR.PR and SD

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
4

safety including any grade adverse events

The adverse event type and the proportion of AE during the progress of disease treatment

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: