AcceleRET Lung Study of Pralsetinib for 1L RET Fusion-positive Metastatic NSCLC

  • STATUS
    Recruiting
  • End date
    Dec 28, 2024
  • participants needed
    250
  • sponsor
    Blueprint Medicines Corporation
Updated on 19 February 2024
cancer
pulmonary disease
immunomodulator
measurable disease
metastasis
gemcitabine
platinum-based chemotherapy
carboplatin
pembrolizumab
lung cancer
pemetrexed
chemotherapy regimen
progressive disease
adenocarcinoma
chemoradiotherapy
cancer treatment
carcinoma
immunomodulators
cancer chemotherapy
stage iv non-small cell lung cancer
cancer therapy
pralsetinib
ret inhibitor
lung disease
head and neck neoplasms
immunostimulants
stage iv nsclc
metastatic cancer
metastatic non-small cell lung cancer
adjuvant
non-small cell lung cancer
small cell lung cancer
cisplatin
met inhibitor
bronchogenic carcinoma
lung neoplasm
respiratory tract diseases
neoplasms by site

Summary

This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcome 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 patients with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease. Patients who have centrally confirmed progressive disease on the control arm have the option to crossover to pralsetinib.

Details
Condition Bronchogenic Carcinoma, Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer, Pulmonary Disease, Adenocarcinoma, Adenocarcinoma, Cancer, Respiratory Tract Diseases, Respiratory Tract Neoplasm, Thoracic Neoplasms, Carcinoma, Lung Neoplasm, Bronchial disorder, head and neck cancer, head and neck cancer, Neoplasms, Nerve Tissue, Germ cell tumor, Neoplasms by Histologic Type, Neoplasms by Site, RET-fusion Non Small Cell Lung Cancer
Age 18-100 years
Treatment Carboplatin, Pembrolizumab, Pemetrexed, Gemcitabine, Cisplatin, Pralsetinib
Clinical Study IdentifierNCT04222972
SponsorBlueprint Medicines Corporation
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient is 18 years of age
Patient has pathologically confirmed, definitively diagnosed, advanced (not able to be treated with surgery or radiotherapy) or metastatic NSCLC and has not been treated with systemic anticancer therapy for metastatic disease
Patient must have a documented RET-fusion
Patient has measurable disease based on RECIST 1.1 as determined by the local site Investigator/radiology assessment
Patient has an ECOG PS of 0-1
Patient should not have received any prior anticancer therapy for metastatic disease
Patients can have received previous anticancer therapy (except a selective RET inhibitor) in the neoadjuvant or adjuvant setting but must have experienced an interval of at least 6 months from completion of therapy to recurrence
Patients that received previous immune checkpoint inhibitors in the adjuvant or consolidation following chemoradiation are not allowed to receive pembrolizumab if randomized in Arm B
Patient is an appropriate candidate for and agrees to receive 1 of the Investigator choice platinum-based chemotherapy regimens if randomized to Arm B
Patient provides signed informed consent to participate in the study

Exclusion Criteria

Patient's tumor has any additional known primary driver alterations other than RET, such as targetable mutations of EGFR, ALK, ROS1, MET, and BRAF. Investigators should discuss enrollment with Sponsor designee regarding co-mutations
Patient previously received treatment with a selective RET inhibitor
Patient received radiotherapy or radiosurgery to any site within 14 days before randomization or more than 30 Gy of radiotherapy to the lung in the 6 months before randomization
Patient has a presence of Grade 2 or worse interstitial lung disease or interstitial pneumonitis, including radiation pneumonitis within 28 days before randomization
Patient has CNS metastases or a primary CNS tumor that is associated with progressive neurological symptoms or requires increasing doses of corticosteroids to control the CNS disease. If a patient requires corticosteroids for management of CNS disease, the dose must have been stable for the 2 weeks before Cycle 1 Day 1
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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