What is the mechanism of action of this treatment?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immune checkpoint inhibitors and tyrosine kinase inhibitors. Immune checkpoint inhibitors, like Tislelizumab, block the PD-1/PD-L1 pathway, enhancing the immune system's ability to attack cancer cells. Tyrosine kinase inhibitors, such as Sitravatinib, target enzymes that regulate tumor growth and angiogenesis, thereby inhibiting tumor progression. These mechanisms are important for NSCLC patients as they help tailor treatments to effectively target the cancer based on its specific characteristics.

What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immune checkpoint inhibitors like Tislelizumab, Pembrolizumab, and Nivolumab, which can cause side effects such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Tyrosine kinase inhibitors like Sitravatinib can lead to hypertension, proteinuria, diarrhea, fatigue, and hand-foot syndrome. These treatments aim to enhance the immune response and inhibit tumor growth and angiogenesis, but they also carry risks of significant immune-related and systemic toxicities.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Small Cell Lung Cancer (NSCLC) that involve anti-PD-1/PD-L1 antibodies and tyrosine kinase inhibitors. Pembrolizumab (Keytruda) and Nivolumab (Opdivo) are anti-PD-1 antibodies approved for use in various settings of NSCLC, often in combination with chemotherapy. Atezolizumab (Tecentriq), an anti-PD-L1 antibody, is also approved for NSCLC treatment. Tyrosine kinase inhibitors like Erlotinib (Tarceva) and Gefitinib (Iressa) target specific mutations in NSCLC. Combination therapies, such as Atezolizumab with chemotherapy, have shown efficacy in clinical trials and are part of the evolving treatment landscape for advanced NSCLC.

What other types of research exist?

Promising novel alternatives for NSCLC treatment in 2024 include combinations such as Pembrolizumab plus chemotherapy, Atezolizumab plus chemotherapy, and Lenvatinib plus Pembrolizumab. These combinations have shown improved overall survival and progression-free survival in clinical trials. Additionally, other combinations under clinical development, such as immune checkpoint inhibitors with olaparib, may also offer new therapeutic options.

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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

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests a combination of two drugs, tislelizumab and sitravatinib, in patients with advanced lung cancer who haven't responded to standard treatments. The goal is to see if this combination can better fight the cancer by boosting the immune system and blocking cancer growth signals.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival (OS)

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

Secondary study objectives

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

+4 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2017

Completed Phase 2

~510

Tislelizumab

2018

Completed Phase 3

~4560

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immune checkpoint inhibitors and tyrosine kinase inhibitors. Immune checkpoint inhibitors, like Tislelizumab, block the PD-1/PD-L1 pathway, enhancing the immune system's ability to attack cancer cells. Tyrosine kinase inhibitors, such as Sitravatinib, target enzymes that regulate tumor growth and angiogenesis, thereby inhibiting tumor progression. These mechanisms are important for NSCLC patients as they help tailor treatments to effectively target the cancer based on its specific characteristics.