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Tyrosine Kinase Inhibitor

Tislelizumab + Sitravatinib for Lung Cancer

Phase 3

Waitlist Available

Research Sponsored by BeiGene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first randomization up to 35 months, approximately

Awards & highlights

Study Summary

This trial will study whether adding tislelizumab to sitravatinib can help people with lung cancer who have progressed after other treatments.

Who is the study for?

This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) who've seen their disease progress after platinum-based chemo and anti-PD-1/PD-L1 therapy. They should have at least one measurable lesion, no prior treatment like sitravatinib, and no major mutations in EGFR, BRAF, ALK or ROS1 genes. People with active autoimmune diseases, certain types of NSCLC with risk of bleeding, or those previously treated with docetaxel are excluded.Check my eligibility

What is being tested?

The study tests the effectiveness and safety of combining tislelizumab (an immune checkpoint inhibitor) with sitravatinib (a drug that targets specific proteins to stop tumor growth), versus using docetaxel alone in participants whose NSCLC has worsened despite previous treatments.See study design

What are the potential side effects?

Potential side effects include typical reactions to immunotherapy such as fatigue, skin issues, inflammation-related symptoms affecting various organs; plus side effects related to tyrosine kinase inhibitors like high blood pressure and diarrhea. Docetaxel can cause hair loss, nausea, neutropenia which increases infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first randomization up to 35 months, approximately

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first randomization up to 35 months, approximately

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first randomization up to 35 months, approximately for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall survival (OS)

Progression-free survival (PFS) as assessed by Independent Review Committee (IRC)

Secondary outcome measures

Disease control rate (DCR)

Duration of Response (DOR)

Health-related quality of life (HRQoL) as assessed according to the European Organization and Treatment of Cancer lung cancer module, QLQ-LC13

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A: Tislelizumab in combination with SitravatinibExperimental Treatment2 Interventions

tislelizumab 200 mg intravenously once every 3 weeks in combination with sitravatinib 100 mg orally once a day

Group II: Arm B: DocetaxelActive Control1 Intervention

docetaxel 75 mg/m2 intravenously once every 3 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sitravatinib

2021

Completed Phase 2

~700

Tislelizumab

2018

Completed Phase 3

~4260

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor

175 Previous Clinical Trials

28,437 Total Patients Enrolled

Cheng ChenStudy DirectorBeiGene

Jian LiStudy DirectorBeiGene

4 Previous Clinical Trials

128 Total Patients Enrolled

Media Library

Non-Small Cell Lung Cancer Research Study Groups: Arm A: Tislelizumab in combination with Sitravatinib, Arm B: Docetaxel

Non-Small Cell Lung Cancer Clinical Trial 2023: Sitravatinib Highlights & Side Effects. Trial Name: NCT04921358 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the patient safety profile for Tislelizumab in combination with Sitravatinib?

"Tislelizumab in combination with Sitravatinib has been given a safety score of 3."

Answered by AI

What are the primary cancers that Tislelizumab and Sitravatinib have been shown to be effective against?

"Tislelizumab in conjunction with Sitravatinib is an accepted cancer treatment for neoplasms that are malignant. Additionally, it can be used to target other serious conditions such as esophageal neoplasms and sarcoma."

Answered by AI

Could you provide an estimate for how many individuals are included in this research project?

"Yes, the trial is presently looking for patients, as indicated by the clinicaltrials.gov listing. This particular study was posted on 7/27/2021 and was edited on 8/23/2022. There are 25 locations enrolling a total of 420 participants."

Answered by AI

What other scientific research has involved Tislelizumab in combination with Sitravatinib?

"449 trials studying the combination of Tislelizumab and Sitravatinib are currently underway, with 150 of those in Phase 3. Most of the trials are based in Melbourne, Victoria, but there are 25264 locations running trials for the Tislelizumab and Sitravatinib combination."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

2021. "Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04921358.