A clinical trial to compare a medicine called pralsetinib with standard-of-care chemotherapy treatments in people with non-small cell lung cancer (NSCLC)

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

  • Non-Small Cell Lung Cancer
Trial Status:

Recruiting

This trial runs in
Countries
  • Australia
  • Belgium
  • Canada
  • Costa Rica
  • France
  • Germany
  • Ireland
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Norway
  • Panama
  • Poland
  • Portugal
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Turkey
  • United Kingdom
  • United States
Trial Identifier:

NCT04222972 2019-002463-10, BLU-667-2303 BO42864

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT04222972 , BO42864 , 2019-002463-10, BLU-667-2303 Trial Identifier
      All Gender
      ≥18 Years Age
      No Healthy Volunteers

      How does the AcceleRET-Lung clinical trial work?
      AcceleRET-Lung is a phase III clinical trial comparing new treatments with the best standard-of-care chemotherapy treatments currently available. The purpose of this clinical trial is to compare the effects, good or bad, of pralsetinib treatment against the clinical trial doctor’s choice of standard-of-care chemotherapy treatment, in patients who have a type of lung cancer called non-small cell lung cancer (NSCLC) with changes in a gene called RET

      This clinical trial is recruiting people with NSCLC that cannot be removed through surgery or that has spread to other parts of the body. 

      If you take part in this clinical trial, you will have a 1 in 2 (50%) chance of receiving either pralsetinib or the standard-of-care chemotherapy treatment chosen by your clinical trial doctor. 

      How do I take part in this clinical trial?
      You will be able to take part in this clinical trial if you: 

      • Are at least 18 years old at the time of giving informed consent
      • Have been diagnosed with NSCLC that cannot be removed through surgery or has spread to other parts of your body 
      • Have changes in a gene called RET (RET fusion-positive NSCLC) detected by a genetic test carried out by your clinical trial doctor

      If you think this clinical trial may be suitable for you and you would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.

      You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.

      Your clinical trial doctor will also collect tumour samples for testing, which may involve an additional procedure. 

      Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part. 

      While taking part in the clinical trial, both men and women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons. 

      What treatment will I be given if I join this clinical trial?
      Pralsetinib works by interfering with the growth of cancer cells and eventually destroys them. Pralsetinib is designed specifically to treat your RET-fusion positive cancer. 

      Everyone who joins this clinical trial will be split into two groups randomly (like flipping a coin) and given either:

      • pralsetinib, as four capsules once a day in three-week (21-day) treatment cycles 
      • OR the clinical trial doctor’s choice of standard-of-care chemotherapy treatment 

       

      If you have been diagnosed with non-squamous NSCLC and are placed in the standard-of-care chemotherapy group, you will have three-week (21-day) treatment cycles of either: 

      • Pemetrexed and either carboplatin or cisplatin as infusions into the vein on Day 1
      • OR pembrolizumab and either carboplatin or cisplatin and pemetrexed as infusions into the vein on Day 1 

      If you have been diagnosed with squamous NSCLC and are placed in the standard-of-care chemotherapy group, you will have three-week (21-day) treatment cycles of either:

      • Carboplatin or cisplatin as infusions into the vein on Day 1, and gemcitabine as an infusion into the vein on Days 1 and 8 
      • OR carboplatin and pembrolizumab as infusions into the vein on Day 1 with either:
        • paclitaxel on Day 1 
        • OR nab-paclitaxel on Days 1, 8 and 15 

      The type of standard-of-care chemotherapy treatment you will receive will depend on your NSCLC and your clinical trial doctor will be able to explain this to you. You will have four or six cycles of standard-of-care chemotherapy treatment. Each treatment cycle will last for three weeks. 

      If you are receiving standard-of-care chemotherapy treatment and your cancer worsens, you may be given the chance to switch treatment groups and receive pralsetinib treatment. Patients who are eligible to switch treatment groups to receive pralsetinib treatment must first provide written informed consent. 

      This is an open-label trial which means that you and your clinical trial doctor will both know which treatment you are receiving.

      How often will I be seen in follow-up appointments and for how long?
      You will continue to receive clinical trial treatment until your NSCLC worsens, you can no longer tolerate the treatment, or your clinical trial doctor decides you must stop treatment. You are free to stop this treatment at any time. During the clinical trial, you will have visits approximately every three weeks (21 days) while you are receiving treatment to see how you are responding and check any side effects that you may be having. Visits may last for several hours. 

      You will have one clinic visit roughly one month after your final dose of clinical trial treatment. You will then have regular check-ups roughly every three months, so that the clinical trial doctor can check whether your cancer has got worse. If your cancer gets worse, these visits will stop and you will have telephone appointments every three months instead, for as long as you agree. 

      Your check-ups with your clinical trial doctor will include a physical examination and heart rate monitoring. You will also need to provide a urine sample and answer a health questionnaire. 

      What happens if I am unable to take part in this clinical trial?
      If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.

      For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT04222972

      Trial-identifier: NCT04222972

      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT04222972 , BO42864 , 2019-002463-10, BLU-667-2303 Trial Identifier
      Pralsetinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab, Gemcitabine, Paclitaxel, Nab-Paclitaxel Treatments
      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 Condition
      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

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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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