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

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

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

Treatments tested in this trial

  • Tislelizumab
  • Anlotinib

Treatment groups

33 Participants
are divided into 1 treatment group

Locations

This trial has no locations