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Tyrosine Kinase Inhibitor

Zipalertinib for Non-Small Cell Lung Cancer (REZILIENT1 Trial)

Verified Trial
Phase 1 & 2
Recruiting
Research Sponsored by Cullinan Oncology, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are you able to carry out light work throughout your day?
Have you been diagnosed with advanced or metastatic non small cell lung cancer?
Must not have
Do you currently smoke?
Have you previously been treated with poziotinib, mobocertinib, amivantamab, DZD9008, or BDTX-189?
Timeline
Screening 28 days
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

REZILIENT1 Trial Summary

This trial is testing a new drug for patients with a specific type of lung cancer. The goal is to find the best dose of the drug and to see if it is effective.

Who is the study for?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has a specific mutation called EGFR exon 20 insertion. Participants can be new to treatment or have had certain prior therapies, but not treatments targeting this specific mutation or CLN-081. They should be able to do light work and must not currently smoke or have used tobacco recently.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of a drug named CLN-081 in patients with NSCLC who have the EGFR exon 20 insertion mutation. It's an early-stage trial aiming to find the best dose for Phase 2 and see how well it works against this type of lung cancer.See study design
What are the potential side effects?
While side effects are being studied, potential risks may include typical reactions seen with cancer drugs such as fatigue, digestive issues, skin changes, blood disorders, and possibly effects on lung function given concerns about excluding those with past severe pneumonitis.

REZILIENT1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can do light work throughout the day.
Select...
I have advanced or metastatic non-small cell lung cancer.
Select...
My cancer has an EGFR ex20ins mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not been treated with poziotinib, mobocertinib, amivantamab, DZD9008, or BDTX-189.

REZILIENT1 Trial Timeline

Screening ~ 28 days
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 28 days for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Module B: To see if zipalertinib is safe and effective in patients who had prior chemotherapy or standard treatment
Module C: To see if zipalertinib is safe and effective in patients who had prior therapy with an agent approved for EGFR exon20 insertion mutation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

REZILIENT1 Trial Design

2Treatment groups
Experimental Treatment
Group I: Module CExperimental Treatment1 Intervention
Patients who have previously progressed on targeted treatment for their exon20 insertion mutation will be given a standard determined dose of Zipalertinib.
Group II: Module BExperimental Treatment1 Intervention
Patients who have previously progressed on chemotherapy treatment will be given a standard determined dose of Zipalertinib.

Find a Location

Who is running the clinical trial?

Cullinan Oncology, LLCLead Sponsor
6 Previous Clinical Trials
768 Total Patients Enrolled
Cullinan PearlLead Sponsor
Zosia Piotrowska, MDStudy ChairMassachusetts General Hospital
1 Previous Clinical Trials
156 Total Patients Enrolled

Media Library

CLN-081 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04036682 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Module C, Module B
Non-Small Cell Lung Cancer Clinical Trial 2023: CLN-081 Highlights & Side Effects. Trial Name: NCT04036682 — Phase 1 & 2
CLN-081 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04036682 — Phase 1 & 2

Frequently Asked Questions

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

How many people have been treated with Zipalertinib before me?

"To date over 200 people have been treated with Zipalertinib"

Verified Answer

How safe is Zipalertinib alone or in combination with chemotherapy?

"The study drug is zipalertinib alone, not combined with chemotherapy. The safety profile is favorable and manageable comparing with other treatments and for details"

Verified Answer

Will I know what medication I'm taking?

"Yes, all patients in the trial are treated with Zipalterinib"

Verified Answer

Can participants with other forms of cancer participate in this trial?

"No"

Verified Answer

Will I have access to the study drug or treatment after the trial ends?

"No"

Verified Answer

Can I leave this clinical trial if I change my mind or experience side effects?

"Yes, participation in the study is voluntary and you may leave the trial at any time if you decided to"

Verified Answer

Can I participate in this clinical trial while receiving other treatments?

"No other anti-tumor treatment allowed."

Verified Answer

How long will I be required to participate in this clinical trial?

"Participation in the study will continue until you choose to stop or until your disease worsens, you have a requirement for another anticancer treatment, it is not in your best interest to continue or you have an adverse event which is unmanageable."

Verified Answer

Who else is applying?

What state do they live in?
Texas
How old are they?
< 18
65+
18 - 65
What site did they apply to?
University of Michigan Health System - University Hospital
Pacific Cancer Medical Center, Inc
Other
AdventHealth Hematology and Oncology
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I have had a Lobectomy, radiation and chemo twice. Last year with Carboplatin. Cancer still spread and am now doing Carboplatin and Taxol. Looking for a miracle.
PatientReceived 1 prior treatment
During a recent CAT scan Dr's discovered a 21mm Squamish cancer spot on my left lobe. PET scan Jan 2nd to see if it has spread. About to start immunotherapy. I'm seeking Additional treatments and want to further help cancer studies. I'm otherwise super healthy, athletic, 58 year old man.
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. NYU Cancer Institute: < 24 hours
  2. AdventHealth Hematology and Oncology: < 24 hours
  3. Hollings Cancer Center Medical University Of South Carolina: < 24 hours
Average response time
  • < 2 Days
Typically responds via
Email
Phone Call
~46 spots leftby Dec 2024