Pralsetinib for Lung Cancer

(AcceleRET-Lung Trial)

Recruiting at 161 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: Unknown

223 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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.

Treatment Details

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.

Participant Groups

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