Pralsetinib for Lung Cancer

(AcceleRET-Lung Trial)

No longer recruiting at 180 trial locations

Overseen By Reference Study ID Number: BO42864 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hoffmann-La Roche

Must not be taking: Selective RET inhibitors

Disqualifiers: EGFR, ALK, ROS1, MET, BRAF, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 21

Duration: Estimated up to 32 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether pralsetinib, a new medication, can improve outcomes for people with RET fusion-positive metastatic NSCLC, a specific type of lung cancer. Participants will receive either pralsetinib or a standard chemotherapy treatment chosen by their doctor. The trial aims to determine if pralsetinib can help patients live longer without cancer progression. Individuals diagnosed with this type of lung cancer who have not yet received treatment might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it does mention that participants should not have received any prior anticancer therapy for metastatic disease.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that pralsetinib is generally safe for treating lung cancer. One study involved 281 patients with RET fusion-positive NSCLC who took pralsetinib for about 15 months on average. This study found that pralsetinib was effective and safe for these patients. Another review of real-world data confirmed some known side effects, such as heart, blood, and stomach issues, but overall, it supported pralsetinib's safety.

Despite some side effects, pralsetinib is usually well-tolerated. It has been tested in many patients, and these studies help ensure its safety for those considering joining this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Pralsetinib is unique because it specifically targets a genetic mutation known as RET fusions, which are found in some types of lung cancer. This is different from the standard lung cancer treatments like platinum-based chemotherapy and pembrolizumab, which do not target this specific mutation. Researchers are excited about pralsetinib because it offers a more personalized treatment option that could potentially be more effective for patients with this particular genetic profile. By focusing on the RET fusion mutation, pralsetinib aims to provide a more precise and effective treatment, potentially leading to better outcomes for those affected.

What evidence suggests that pralsetinib might be an effective treatment for lung cancer?

Studies have shown that pralsetinib effectively treats RET fusion-positive non-small cell lung cancer (NSCLC). Research indicates that patients taking pralsetinib had a median time of 16.4 months before their cancer worsened, allowing many to live longer without progression. Additionally, real-world data shows a median overall survival of 23.8 months for patients using pralsetinib. This trial will compare pralsetinib to platinum-based chemotherapy, with or without pembrolizumab, another treatment option under study. These findings suggest that pralsetinib can effectively manage this type of lung cancer, helping to control the disease for extended periods. ^{2 3 4 5 6}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

My cancer can be measured by scans.

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

Exclusion Criteria

I have been treated with a selective RET inhibitor before.

My tumor has genetic changes other than RET that can be targeted with treatment.

I have had pneumonitis in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Pralsetinib or a platinum-based chemotherapy regimen with or without pembrolizumab

Estimated up to 32 months

Every 21-day cycle visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

Estimated up to 32 months

What Are the Treatments Tested in This Trial?

Interventions

• Pralsetinib

Trial Overview

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.

How Is the Trial Designed?

Group I: Pralsetinib Experimental Treatment 1 Intervention

Participants randomized to the Experimental Arm will receive Pralsetinib

Group II: Platinum-based chemotherapy with or without pembrolizumab Active Control 7 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

Pralsetinib is already approved in United States, European Union for the following indications:

Approved in United States as Gavreto for:

• Non-small cell lung cancer (NSCLC) with RET fusions
• Medullary thyroid cancer (MTC) with RET mutations
• Thyroid cancer with RET fusions

Approved in European Union as Gavreto for:

• Non-small cell lung cancer (NSCLC) with RET fusions

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Citations

1.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK601718/

Clinical Review - Pralsetinib (Gavreto) - NCBI - NIH

Median PFS was 16.4 months (95% CI, 11.0 to 24.1), with 56.2% of patients censored at data cut-off. Health-Related Quality of Life. Baseline mean global health ...

2.

jtocrr.org

jtocrr.org/article/S2666-3643(24)00113-9/fulltext

Real-World Outcomes of Pralsetinib in RET Fusion-Positive ...

Median overall survival from pralsetinib initiation was 23.8 (95% CI: 16.5–not reached) months. Conclusion. In this extensive real-world cohort ...

3.

gavreto-hcp.com

gavreto-hcp.com/mnsclc/efficacy/

RET+ mNSCLC Trial Information | GAVRETO® (pralsetinib)

Efficacy and safety with GAVRETO (400 mg orally once daily) were evaluated in patients with RET fusion-positive mNSCLC in the ARROW study, a phase 1/2, ...

4.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.8644

Efficacy and safety of pralsetinib in patients with advanced ...

Results: 281 patients with RET-fusion-positive NSCLC received pralsetinib 400 mg QD, with a median duration of treatment of 14.95 months (mos).

5.

lungcancerjournal.info

lungcancerjournal.info/article/S0169-5002(24)00470-7/fulltext

Efficacy and safety of pralsetinib in patients with RET fusion ...

Pralsetinib demonstrated promising activity in patients with advanced NSCLC harboring RET fusion with a favorable safety profile.

6.

nature.com

nature.com/articles/s41598-025-17627-5

Real-world FAERS safety analysis of Pralsetinib

This FAERS analysis confirms established pralsetinib-associated adverse events including cardiovascular, hematologic, and gastrointestinal ...