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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.

Must not have

Participant previously received treatment with a selective RET inhibitor.

Participant with a history of pneumonitis within the last 12 months.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up estimated at up to 32 months

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with a selective RET inhibitor before.

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I have had pneumonitis in the past year.

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I haven't had radiotherapy in the last 14 days or high-dose lung radiotherapy in the last 6 months.

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I have had another type of cancer or needed cancer treatment in the last 3 years.

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

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

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

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

Clinical Benefit Rate (CBR)

Disease Control Rate (DCR)

+4 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

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

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 / 11Eligibility criteria met