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Tyrosine Kinase Inhibitor

Pralsetinib for Lung Cancer (AcceleRET-Lung Trial)

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom and agree to refrain from donating sperm.

Participant has measurable disease based on RECIST 1.1 as determined by the local site Investigator/radiology assessment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up estimated at up to 32 months

Awards & highlights

AcceleRET-Lung Trial Summary

This trial is testing whether a new drug, pralsetinib, can improve outcomes compared to existing cancer treatments for people with a certain type of lung cancer.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer (NSCLC) that haven't had systemic treatment for metastatic disease. They must have a specific RET fusion-positive tumor, good performance status, and no prior selective RET inhibitors. Previous therapy is okay if it was over 6 months ago. Women must use contraception; men agree to abstain or use condoms.Check my eligibility

What is being tested?

The study compares pralsetinib, a targeted drug for tumors with RET gene changes, against standard platinum-based chemotherapy regimens chosen by the investigator. The main goal is to see if pralsetinib can delay the cancer's progression better than existing treatments.See study design

What are the potential side effects?

Pralsetinib may cause high blood pressure, liver problems, bleeding issues, slow wound healing and tiredness among other side effects. Standard chemotherapies can lead to hair loss, nausea/vomiting, increased risk of infection due to low blood counts and potential damage to nerves causing numbness.

AcceleRET-Lung Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man and agree to either not have sex or use a condom and not donate sperm.

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My cancer can be measured by scans.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I've had cancer treatment before, but it's been over 6 months since my last treatment and my cancer has come back.

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My lung cancer is advanced or has spread, and I haven't had systemic treatment for it.

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My cancer has a documented RET-fusion.

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I have not received immune checkpoint inhibitors before pembrolizumab if in Arm B.

AcceleRET-Lung Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ estimated at up to 32 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~estimated at up to 32 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and estimated at up to 32 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

Progression Free Survival (PFS)

Secondary outcome measures

Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS)

Clinical Benefit Rate (CBR)

Disease Control Rate (DCR)

+6 more

AcceleRET-Lung Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PralsetinibExperimental Treatment1 Intervention

Participants randomized to the Experimental Arm will receive Pralsetinib

Group II: Platinum-based chemotherapy with or without pembrolizumabActive Control7 Interventions

Participants randomized to the Active Comparator Arm will receive 1 of 6 platinum-based chemotherapy treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating Investigator (based on histology) Nonsquamous histology Carboplatin or cisplatin / pemetrexed (with vitamin supplementation); with optional pemetrexed (with vitamin supplementation) maintenance. Pembrolizumab / carboplatin or cisplatin / pemetrexed (with vitamin supplementation); followed by pembrolizumab and optional pemetrexed (with vitamin supplementation) maintenance. Squamous histology Carboplatin or cisplatin / gemcitabine Carboplatin with paclitaxel/nab-paclitaxel and pembrolizumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pralsetinib

2021

Completed Phase 2

~260

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,428 Previous Clinical Trials

1,088,833 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,199 Previous Clinical Trials

888,281 Total Patients Enrolled

Media Library

Pralsetinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04222972 — Phase 3

Non-Small Cell Lung Cancer Research Study Groups: Platinum-based chemotherapy with or without pembrolizumab, Pralsetinib

Non-Small Cell Lung Cancer Clinical Trial 2023: Pralsetinib Highlights & Side Effects. Trial Name: NCT04222972 — Phase 3

Pralsetinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04222972 — Phase 3

Frequently Asked Questions

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

How many people are signing up to participate in this clinical trial?

"That is correct. The information available on clinicaltrials.gov indicates that the trial is still actively recruiting patients. This particular study was first posted on July 24th, 2020 and has since been updated on November 10th, 2020. They are looking for a total of 226 individuals across 3 different locations."

Answered by AI

Are there any patients currently being signed up for this experiment?

"That is accurate. The clinicaltrials.gov website does say that the trial is recruiting patients as of right now. This specific study was posted on 7/24/2020, and the last update to it was 11/10/2022. They are looking for 226 patients total from 3 different hospitals or medical facilities."

Answered by AI

What other scientific papers mention Pralsetinib?

"City of Hope Comprehensive Cancer Center first began studying pralsetinib in 1997. Since then, a total of 3069 clinical trials have completed. However, there are still 2573 active studies recruiting patients. The majority of these studies are based in Ste. Foy, Quebec."

Answered by AI

Are there any known risks associated with taking Pralsetinib?

"Pralsetinib has received a score of 3 for safety from our team at Power. This is because it is a Phase 3 trial, meaning there is some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

For what purpose is Pralsetinib regularly employed?

"Pralsetinib is most commonly used to target and treat neoplasm metastasis. It can also be effective against malignant melanoma of skin, recurrent cervical cancer, and refractory, relapsed mediastinal large b-cell lymphoma."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

2020. "A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04222972.

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