External Control, Observational, Retrospective Study Comparing Pralsetinib to Best Available Therapy in Patients With RET-Fusion Positive NSCLC

Last updated: August 9, 2021
Sponsor: Blueprint Medicines Corporation
Overall Status: Active - Enrolling

Phase

N/A

Condition

Carcinoma

Neoplasms

Testicular Cancer

Treatment

N/A

Clinical Study ID

NCT04697446
BLU-667-2404
  • Ages > 18
  • All Genders

Study Summary

This is an external control, observational, retrospective study designed to compare clinical outcomes for pralsetinib compared with best available therapy for patients with RET-fusion positive advanced NSCLC.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must have a diagnosis of locally advanced (non-resectable) or metastatic RET-fusionpositive NSCLC
  • Must have received at least one line of systemic therapy for locally advanced (non-resectable) or metastatic RET-fusion positive NSCLC, which may include regimenscontaining:
  • Chemotherapy, e.g., regimens containing platinum doublet-based therapy (carboplatin, cisplatin)
  • Chemotherapy in combination with other drugs will be assessed, e.g., incombination with pemetrexed, immune checkpoint inhibitors (pembrolizumab),bevacizumab
  • Ramucirumab in combination with docetaxel
  • Immune checkpoint inhibitors, e.g., pembrolizumab, nivolumab, and atezolizumab
  • MKIs, e.g., cabozantinib, alectinib, vandetanib, sunitinib, and nintedanib
  • Must be aged ≥18 years of age at the initiation of first systemic line of therapy
  • Must have availabile of performance status (e.g., Eastern Cooperative Oncology Group [ECOG] score or Karnofsky score)
  • Must have an index date at least 3 months prior to the start of data collection (inorder to include patients with at least 3 months of follow-up after index date),unless date of death occurred less than three months from index date
  • Must have an approved waiver of informed consent or signed informed consent forparticipation in the retrospective chart review study, as applicable

Exclusion

Exclusion Criteria:

  • Known primary driver alteration other than RET (e.g., targetable mutation in EGFR,ALK, ROS1, or BRAF)
  • History of other malignancy, other than non-melanoma skin cancer, within 1 year priorto initiation of first systemic therapy
  • Received pralsetinib as the first line of systemic therapy for RET-fusion positiveNSCLC, or prior to initiation of first systemic therapy

Study Design

Total Participants: 279
Study Start date:
December 01, 2020
Estimated Completion Date:
October 31, 2021

Connect with a study center

  • University Hospital Center of Toulouse - Larrey Hospital

    Toulouse, 31300
    France

    Site Not Available

  • Lucerne Cantonal Hospital

    Lucerne, 6000
    Switzerland

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

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