Tislelizumab Combined With Anlotinib and Nab-paclitaxel in III Resectable Non-small Cell Lung Cancer : A Prospective, Single-Arm, Phase II Study

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQilu Hospital of Shandong University

About this trial

This study is a single-arm prospective clinical trial. The primary objective of the study is to explore the efficacy and safety of preoperative neoadjuvant therapy with Tislelizumab combined with Anlotinib and Nab-Paclitaxel in resectable stage III non-small cell lung cancer.Finally, it provides new evidence-based medical evidence for the perioperative treatment of non-small cell lung cancer.

Eligibility criteria

Qualifiers

Age 18-75 years old, gender is not limited;

Histologically confirmed Stage III non-small cell lung cancer (AJCC Stage 8th edition)

The tumor is resectable after assessment by the attending surgeon

EGFR/ALK mutation negative or unknown (unknown only for squamous non-small cell lung cancer)

Disqualifiers

A history of received treatment for current lung cancer, including radiotherapy and all systemic antitumor agents, including chemotherapy, immunotherapy, targeted therapy or antiangiogenic therapy.

Patients with known EGFR gene mutation, ALK rearrangement, ROS-1 fusion, RET fusion, HER-2 mutation, MET mutation, but if patients with squamous non-small cell lung cancer, the EGFR mutation status and ALK mutation status are unknown, it is not required to conduct tests during screening

There are multiple factors influencing patients taking oral medication (such as inability to swallow, chronic diarrhea, intestinal obstruction)

Allergy to any study drug (Tislelizumab, Anlotinib, albumin-bound Paclitaxel) or excipients.

Trial design

Treatments tested in this trial

  • neoadjuvant therapy
  • Surgery
  • Adjuvant therapy

Treatment groups

34 Participants
are divided into 1 treatment group