MedTrace Logo

An Exploratory Study of Tislelizumab in Combination with Chemotherapy in Immuno-experienced Patients with EGFR/ALK/ROS1-negative Advanced NSCLC in the Second-line Setting

NCT06749886 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-12-27

No results posted yet for this study

Summary

The goal of this clinical trial is to explore the efficacy and safety of denosumab in combination with tislelizumab and chemotherapy in the second-line treatment of immuno-experienced patients with EGFR/ALK/ROS1-negative advanced NSCLC.

Primary endpoint:

progression-free survival (PFS) assessed by investigators according to RECIST 1.1;

Secondary endpoint:

1. Overall survival (OS) assessed by investigators according to RECIST 1.1;
2. Objective response rate (ORR) assessed by investigators according to RECIST 1.1;
3. Disease control rate (DCR) assessed by investigators according to RECIST 1.1;
4. Duration of response (DOR) assessed by investigators according to RECIST 1.1;

Exploratory endpoint:

bone metastasis-free survival.

Participants will receive denosumab combined with tislelizumab and docetaxel.

Conditions

Interventions

DRUG

Denosumab

Denosumab, 120 mg subcutaneous injection, every 21-28 days a cycle, given on the first day, a loading dose is given on d8 of the first cycle, and continued use

DRUG

tislelizumab

Tislelizumab, 200 mg intravenous infusion, every 21 days a cycle, given on the first day, and continued use

DRUG

Docetaxel

Docetaxel, 60 mg/m2 intravenous infusion, every 21 days a cycle, given on the first day, and continued use.

Sponsors & Collaborators

  • Shanghai Pulmonary Hospital, Shanghai, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-19
Primary Completion
2026-11-30
Completion
2027-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06749886 on ClinicalTrials.gov