XL092 for Non-Small Cell Lung Cancer

Exelixis Clinical Site #32, Pittsburgh, PA
Non-Small Cell Lung Cancer+7 More ConditionsXL092 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the safety and effectiveness of a new drug, XL092, for treating advanced solid tumors. The drug will be tested alone and in combination with two other drugs, nivolumab and ipilimumab, to see if it is effective and has any harmful side effects.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Solid Tumors
  • Kidney Cancer
  • Liver Cancer
  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Metastatic Castration Resistant Prostate Cancer
  • Bladder Cancer
  • Colorectal Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Similar Trials

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: up to 36 months

6 months
Expansion Stage: Overall Survival (OS)
up to 24 months
Expansion Stage: Objective Response Rate (ORR)
Expansion Stage: Progression-Free Survival (PFS)
up to 36 months
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including immune-mediated adverse events (imAEs)

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

11 Treatment Groups

XL092 + Nivolumab + Relatlimab Expansion Cohorts
1 of 11
XL092 + Nivolumab + Ipilimumab Expansion Cohorts
1 of 11
XL092 + Nivolumab + Relatlimab Dose-Escalation Cohorts
1 of 11
XL092 + Nivolumab + Bempegaldesleukin Expansion Cohorts
1 of 11
XL092 + Nivolumab Dose-Escalation Cohorts
1 of 11
XL092 + Nivolumab + Bempegaldesleukin Dose-Escalation Cohorts
1 of 11
Nivolumab + Bempegaldesleukin Expansion Cohorts
1 of 11
Nivolumab + Ipilimumab Expansion Cohorts
1 of 11
XL092 + Nivolumab Expansion Cohorts
1 of 11
XL092 Single-Agent Expansion Cohorts
1 of 11
XL092 + Nivolumab + Ipilimumab Dose-Escalation Cohorts
1 of 11

Experimental Treatment

1078 Total Participants · 11 Treatment Groups

Primary Treatment: XL092 · No Placebo Group · Phase 1

XL092 + Nivolumab + Relatlimab Expansion CohortsExperimental Group · 2 Interventions: Nivolumab + Relatlimab, XL092 · Intervention Types: Drug, Drug
XL092 + Nivolumab + Ipilimumab Expansion CohortsExperimental Group · 3 Interventions: Ipilimumab, Nivolumab, XL092 · Intervention Types: Drug, Drug, Drug
XL092 + Nivolumab + Relatlimab Dose-Escalation CohortsExperimental Group · 2 Interventions: Nivolumab + Relatlimab, XL092 · Intervention Types: Drug, Drug
XL092 + Nivolumab + Bempegaldesleukin Expansion CohortsExperimental Group · 3 Interventions: Bempegaldesleukin, Nivolumab, XL092 · Intervention Types: Drug, Drug, Drug
XL092 + Nivolumab Dose-Escalation CohortsExperimental Group · 2 Interventions: Nivolumab, XL092 · Intervention Types: Drug, Drug
XL092 + Nivolumab + Bempegaldesleukin Dose-Escalation CohortsExperimental Group · 3 Interventions: Bempegaldesleukin, Nivolumab, XL092 · Intervention Types: Drug, Drug, Drug
Nivolumab + Bempegaldesleukin Expansion CohortsExperimental Group · 2 Interventions: Bempegaldesleukin, Nivolumab · Intervention Types: Drug, Drug
Nivolumab + Ipilimumab Expansion CohortsExperimental Group · 2 Interventions: Ipilimumab, Nivolumab · Intervention Types: Drug, Drug
XL092 + Nivolumab Expansion CohortsExperimental Group · 2 Interventions: Nivolumab, XL092 · Intervention Types: Drug, Drug
XL092 Single-Agent Expansion Cohorts
Drug
Experimental Group · 1 Intervention: XL092 · Intervention Types: Drug
XL092 + Nivolumab + Ipilimumab Dose-Escalation CohortsExperimental Group · 3 Interventions: Ipilimumab, Nivolumab, XL092 · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bempegaldesleukin
Not yet FDA approved
Ipilimumab
FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months

Who is running the clinical trial?

ExelixisLead Sponsor
110 Previous Clinical Trials
16,870 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a type of cancer that cannot be removed by surgery or has spread to other parts of your body, and there are no other options to help prolong your life or the current treatments are not tolerable or working anymore.
If you had non-VEGF targeted treatment before, you can still participate if your disease came back at least 6 months after your last treatment.
Men with prostate cancer that has spread to other parts of the body.

Frequently Asked Questions

What have the safety assessments revealed about the efficacy of XL092?

"Due to a lack of clinical data, our team has assigned XL092 a score of 1 on the safety scale. This is because it is currently in Phase 1 trials and no substantial evidence for efficacy or safety exists yet." - Anonymous Online Contributor

Unverified Answer

Are enrollment opportunities currently available to join this experiment?

"Per the information available on clinicaltrials.gov, this medical trial is now accepting participants. The study was first published on December 14th 2021 and the latest modification occurred in September 2022." - Anonymous Online Contributor

Unverified Answer

What health issues is XL092 commonly prescribed to address?

"XL092 may be an effective tool for individuals struggling with prior anti-angiogenic therapy, malignant tumours, and inoperable melanoma." - Anonymous Online Contributor

Unverified Answer

Are there multiple venues within the state which are running this investigation?

"Exelixis Clinical Sites #6 (in New York), #5 (Omaha, Nebraska) and #8 (Tampa, Florida) are recruiting for this study alongside 8 other trial sites." - Anonymous Online Contributor

Unverified Answer

Has XL092 been the subject of any previous scientific research?

"In 2009, XL092 first underwent clinical trials at Texas Children's Hospital. This drug has been studied extensively since then, with 367 completed studies and an additional 766 active ones occurring in locales such as New York City." - Anonymous Online Contributor

Unverified Answer

How many individuals are participating in the experiment?

"This research endeavour necessitates 622 participants that meet the requisite inclusion criteria. Exelixis, the clinical trial sponsor, will be running this study from two of its sites: #5 in Omaha and #6 in New York City." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.