Last updated: August 9, 2021
Sponsor: Blueprint Medicines Corporation
Overall Status: Active - Enrolling
Phase
N/A
Condition
Carcinoma
Neoplasms
Testicular Cancer
Treatment
N/AClinical Study ID
NCT04697446
BLU-667-2404
Ages > 18 All Genders
Study Summary
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
FranceSite Not Available
Lucerne Cantonal Hospital
Lucerne, 6000
SwitzerlandSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
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