NCT04222972|TerminatedPhase 3ResultsDMCFDA Drug

Study Stopped

Early termination of the study resulted from organizational and commercial decisions that led to the discontinuation of pralsetinib's global marketing and development in all territories (excluding US and Greater China).

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

AcceleRET-Lung

A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for First-Line Treatment of RET Fusion-Positive, Metastatic Non-Small Cell Lung Cancer

Hoffmann-La Roche ClinicalTrials.gov

Compare

4 other identifiers

BO428642019-002463-10BLU-667-23032023-505035-12-00

Study Type

interventional

Target

223

Locations

22 countries

Sites

Timeline

RegisteredJan 2020

StartedJul 2020

CompletionJan 2025

Brief Summary

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

223

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Jul 2020

Typical duration for phase_3

Geographic Reach

22 countries

74 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.5 years study duration

First Submitted

Initial submission to the registry

January 3, 2020

Completed

7 days until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed

7 months until next milestone

Study Start

First participant enrolled

July 24, 2020

Completed

4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2025

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

March 5, 2026

Completed

Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

4.5 years

First QC Date

January 3, 2020

Results QC Date

January 5, 2026

Last Update Submit

February 12, 2026

Conditions

RET-fusion Non Small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Disease Carcinoma, Bronchogenic Bronchial Diseases Head and Neck Neoplasms Carcinoma Neoplasms, Nerve Tissue Lung Neoplasm Adenocarcinoma Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal

Keywords

Advanced Non-Small Cell Lung CancerRET LungRET MutationRET AlterationRET PositiveRET InhibitorRET AlteredRET RearrangementRET NSCLCRET-Rearranged NSCLCRET FusionRET Fusion Lung CancerM918TTRIM33-RETLung Cancer MutationBLU 667PralsetinibRET Tyrosine KinaseRET Gene MutationRET KinaseAdvanced Lung CancerMetastatic Lung CancerKIF5B-RETCCDC6-RET

Outcome Measures

Primary Outcomes (1)

Arm A vs Arm B: Treatment Period: Progression-free Survival (PFS)
PFS was defined as the time from randomization to the date of first documented PD as determined by the investigator with the use of Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints, including baseline. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of at least 5 millimeters (mm). Kaplan-Meier (K-M) method was used to estimate median PFS. 95% CI for median was computed using the method of Brookmeyer and Crowley.
Up to approximately 50 months

Secondary Outcomes (7)

Arm A vs Arm B: Objective Response Rate (ORR)
Up to approximately 50 months
Arm A vs Arm B: Overall Survival (OS)
From randomization to death (up to approximately 50 months)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Up to approximately 50 months
Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
Baseline up to 50 months
Arm A vs Arm B: Duration of Response (DOR)
Up to approximately 50 months
+2 more secondary outcomes

Study Arms (2)

Pralsetinib

EXPERIMENTAL

Participants randomized to the Experimental Arm will receive Pralsetinib

Drug: Pralsetinib

Platinum-based chemotherapy with or without pembrolizumab

ACTIVE COMPARATOR

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

Drug: CarboplatinDrug: CisplatinDrug: PemetrexedDrug: PembrolizumabDrug: GemcitabineDrug: PaclitaxelDrug: Nab-Paclitaxel

Interventions

PralsetinibDRUG

Administered orally

Also known as: BLU-667

Pralsetinib

CarboplatinDRUG

Administered IV