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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    226
  • sponsor
    Hoffmann-La Roche
Updated on 5 June 2021
paclitaxel
cancer
measurable disease
lung cancer
treatment regimen
x-rays
metastasis
progressive disease
chemoradiotherapy
pemetrexed
pralsetinib
carboplatin
gemcitabine
pembrolizumab
RET
chemotherapy regimen
cancer treatment
primary cancer
cancer chemotherapy
metastatic cancer
platinum-based chemotherapy
immunomodulator
stage iv nsclc
immunostimulants
administration intravenous
ret inhibitor
stage iv non-small cell lung cancer
lung carcinoma
metastatic non-small cell lung cancer

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. Participants 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, Pulmonary Disease, Adenocarcinoma, Cancer, Respiratory Tract Diseases, Respiratory Tract Neoplasm, Thoracic Neoplasms, Carcinoma, Lung Neoplasm, Bronchial disorder, head and neck cancer, Neoplasms, Nerve Tissue, Germ cell tumor, Neoplasms by Histologic Type, Neoplasms by Site, Vulvar Dysplasia and Carcinoma, Cancer/Tumors, Ewing's Family Tumors, Advanced Malignancies, Cancer (Pediatric), Lung Cancer, Malignant Adenoma, Lung Disease, Neoplasms, Germ Cell Tumors, RET-fusion Non Small Cell Lung Cancer, RET-fusion Non Small Cell Lung Cancer, RET-fusion Non Small Cell Lung Cancer, RET-fusion Non Small Cell Lung Cancer, RET-fusion Non Small Cell Lung Cancer, RET-fusion Non Small Cell Lung Cancer, RET-fusion Non Small Cell Lung Cancer, head and neck neoplasms, head and neck tumor, pulmonary diseases, lung diseases, pulmonary disorders, adenocarcinomas, lung tumor, respiratory tract disease, carcinomas, RET-fusion Non Small Cell Lung Cancer, RET-fusion Non Small Cell Lung Cancer, RET-fusion Non Small Cell Lung Cancer, RET-fusion Non Small Cell Lung Cancer, RET-fusion Non Small Cell Lung Cancer, RET-fusion Non Small Cell Lung Cancer, RET-fusion Non Small Cell Lung Cancer
Treatment cisplatin, carboplatin, Gemcitabine, Paclitaxel, Pembrolizumab, Pemetrexed, Nab-paclitaxel, Pralsetinib
Clinical Study IdentifierNCT04222972
SponsorHoffmann-La Roche
Last Modified on5 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant has pathologically confirmed, definitively diagnosed, locally 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
Participant must have a documented RET-fusion
Participant has measurable disease based on RECIST 1.1 as determined by the local site Investigator/radiology assessment
Participant has an ECOG Performance Status of 0 or 1
Participant should not have received any prior anticancer therapy for metastatic disease
Participants 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
Participants that received previous immune checkpoint inhibitors in the adjuvant or consolidation following chemoradiation are not allowed to receive pembrolizumab if randomized in Arm B
Participant is an appropriate candidate for and agrees to receive 1 of the Investigator choice platinum-based chemotherapy regimens if randomized to Arm B
For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception
For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom and agree to refrain from donating sperm

Exclusion Criteria

Participant'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
Participant previously received treatment with a selective RET inhibitor
Participant 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
Participant with a history of pneumonitis within the last 12 months
Participant 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 participant requires corticosteroids for management of CNS disease, the dose must have been stable for the 2 weeks before Cycle 1 Day 1
Participant has had a history of another primary malignancy that has been diagnosed or required therapy within the past 3 years prior to randomization
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