Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06749886

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

Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2024-12-27

22

Participants Needed

1

Research Sites

136 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histologically or cytologically confirmed stage IV non-bone metastatic NSCLC
  • EGFR, ALK, and ROS1 wild-type tumors
  • Previous first-line immune checkpoint inhibitor treatment with clinical benefit (PFS  3 months)
  • Measurable lesions per RECIST 1.1 criteria
  • ECOG performance status 0 to 2
  • Estimated survival time of at least 3 months
  • Adequate blood counts: neutrophils  1.5 x 10^9/L, platelets  80 x 10^9/L, hemoglobin  90 g/L
  • Adequate liver function: total bilirubin  1.5 times ULN, AST and ALT  2.5 times ULN (or  5 times ULN if liver metastases present)
  • Adequate kidney function: creatinine clearance  50 ml/min
  • Adequate coagulation: INR or PT  1.5 times ULN
  • Negative pregnancy test within 3 days before first dose for women of childbearing potential
  • Use of effective contraception during and for 180 days after treatment if at risk of conception
  • Voluntary informed consent and willingness to comply with study procedures
Not Eligible

You will not qualify if you...

  • Receiving first-line docetaxel chemotherapy
  • Symptomatic brain metastases unless stable for at least 1 month without steroids or anticonvulsants
  • Clinically uncontrollable pleural or ascites effusion requiring frequent drainage
  • Unresolved toxicity or complications from previous treatments above grade 1 (except fatigue or hair loss)
  • Diagnosis of other malignancies within 5 years, except certain skin cancers treated radically
  • Active bleeding, diverticulitis, intra-abdominal abscess, bowel obstruction, or peritoneal metastasis needing intervention
  • History of solid organ or blood system transplantation
  • Severe heart failure (NYHA class III-IV) or uncontrolled significant arrhythmia
  • Active autoimmune disease requiring systemic treatment within 2 years
  • Need for long-term systemic corticosteroids (inhaled or local corticosteroids for COPD/asthma allowed)
  • History of non-infectious pneumonitis needing corticosteroids within 1 year
  • Active infection requiring treatment or recent systemic anti-infective use within 1 week
  • Psychiatric illness or substance abuse affecting study compliance
  • Investigator’s judgment deeming the patient unsuitable for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai Pulmonary Hospital

Shanghai, China, 200433

Actively Recruiting

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Research Team

C

Chunxia Su

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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