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Tyrosine Kinase Inhibitor

Temozolomide plus Lorlatinib for Non-Small Cell Lung Cancer

Phase 1

Waitlist Available

Led By Jose E Pacheco

Research Sponsored by University of Colorado, Denver

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 up to 3.5 years

Awards & highlights

Study Summary

This trial is testing two novel combinations of drugs which have not been evaluated in clinical trials before. The purpose of the trial is to see if adding temozolomide to osimertinib or temozolomide to lorlatinib may provide improvement in CNS disease control in patients with CNS progression on either of these latter two TKIs.

Eligible Conditions

Non-Small Cell Lung Cancer
Central Nervous System

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3.5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Adverse events

Secondary outcome measures

CNS PFS

CNS response rate

Extra-CNS PFS

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Patients with anaplastic lymphoma kinase (ALK) fusionsExperimental Treatment1 Intervention

Will include patients with anaplastic lymphoma kinase (ALK) fusions. Temozolomide plus Lorlatinib will be the study drug combination administered. Lorlatinib will be given at a fixed dose of 100 mg daily. Temozolomide will be started at a dose of 150 mg/m2 on days 1-5 of a 28 day cycle for cycle 1 and if tolerated will be increased to 200 mg/m2 on days 1-5 of a 28 day cycle for cycles 2+. There will be a -1 dose level depending on tolerability.

Group II: Exon 19 deletions or L858R point mutations in exon 21Experimental Treatment1 Intervention

Will include patients with exon 19 deletions or L858R point mutations in exon 21 of the epidermal growth factor receptor (EGFR) gene. Temozolomide plus Osimertinib will be the study drug combination administered. Osimertinib will be given at a fixed dose of 80 mg daily for dose level 1, with a potential to increase to 160 mg daily for dose level 2. Temozolomide will be started at a dose of 150 mg/m2 on days 1-5 of a 28 day cycle for cycle 1 and if tolerated will be increased to 200 mg/m2 on days 1-5 of a 28 day cycle for cycles 2+. There will be a -1 dose level.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide plus Lorlatinib

2020

Completed Phase 1

~10

Temozolomide plus Osimertinib

2020

Completed Phase 1

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cancer League of ColoradoOTHER

8 Previous Clinical Trials

230 Total Patients Enrolled

University of Colorado, DenverLead Sponsor

1,736 Previous Clinical Trials

2,149,194 Total Patients Enrolled

Jose E PachecoPrincipal InvestigatorUniversity of Colorado, Denver

Frequently Asked Questions

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

What is the total number of participants in this clinical experiment?

"Sadly, no new patients are being accepted into this clinical trial. First posted on October 29th 2020 and last updated May 12th 2022, the study has since ceased enrolment. However, there is still hope; currently 742 studies requiring participants with disease progression and 321 trials in need of Temozolomide plus Lorlatinib volunteers are open for registration."

Answered by AI

Have any previous experiments combined Temozolomide and Lorlatinib?

"At the moment, 321 trials examining Temozolomide in combination with Lorlatinib are underway. Of these studies, 41 have entered Phase 3. The primary research centre for such investigations is located in Uniondale, New york; however, 10323 distinct medical facilities across the world are conducting related examinations."

Answered by AI

Is this trial unique in its methodology or have there been similar ones before?

"Worldwide, 321 medical studies for Temozolomide plus Lorlatinib are taking place in over 1367 cities and 52 countries. The pioneering trial of this drug combination began back in 2002 by Schering-Plough with 60 patients participating at the Phase 2 approval stage. To date, a total of 337 trials have been concluded successfully."

Answered by AI

Does the Temozolomide plus Lorlatinib combination pose any considerable risks?

"Based on the limited research available, our Power team has assigned a safety score of 1 to Temozolomide plus Lorlatinib. This is in line with its status as a Phase 1 trial which indicates that there is only sparse data regarding efficacy and general safety."

Answered by AI

In what types of cases is the combination of Temozolomide and Lorlatinib most efficacious?

"Temozolomide in conjunction with Lorlatinib is usually prescribed for malignant neoplasms, but can also be employed to address nitrosourea treatment, advanced directives and intractable, late-stage mycosis fungoides."

Answered by AI

Are there vacancies available to participants in this research endeavor?

"This trial has concluded its recruitment process. Initially published on October 29th 2020 and last updated on May 12th 2022, the study is no longer looking for patients. However, there are currently 742 trials seeking participants with disease progression as well as 321 studies recruiting those requiring Temozolomide plus Lorlatinib treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Temodar Plus Tyrosine Kinase Inhibitors for Progressive CNS Disease

2020. "Temodar Plus Tyrosine Kinase Inhibitors for Progressive CNS Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04541407.