Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
estimated completion

Description

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.

Official Title

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

Keywords

RET-fusion Non Small Cell Lung Cancer Lung Neoplasm 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 Adenocarcinoma Carcinoma Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Advanced Non-Small Cell Lung Cancer RET Lung RET Mutation RET Alteration RET Positive RET Inhibitor RET Altered RET Rearrangement RET NSCLC RET-Rearranged NSCLC RET Fusion RET Fusion Lung Cancer M918T TRIM33-RET Lung Cancer Mutation BLU 667 Pralsetinib RET Tyrosine Kinase RET Gene Mutation RET Kinase Advanced Lung Cancer Metastatic Lung Cancer KIF5B-RET CCDC6-RET Lung Neoplasms Respiratory Tract Diseases Gemcitabine Paclitaxel Albumin-Bound Paclitaxel Carboplatin Pembrolizumab Pemetrexed Cisplatin Nab-Paclitaxel

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UC Irvine Medical Center accepting new patients
    Orange California 92868 United States
  • Southern California Kaiser Permanente accepting new patients
    San Diego California 92108 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT04222972
Phase
Phase 3
Study Type
Interventional
Last Updated