Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04697446
Other study ID # BLU-667-2404
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date October 31, 2021

Study information

Verified date August 2021
Source Blueprint Medicines Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 279
Est. completion date October 31, 2021
Est. primary completion date October 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Must have a diagnosis of locally advanced (non-resectable) or metastatic RET-fusion positive 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 regimens containing: - Chemotherapy, e.g., regimens containing platinum doublet-based therapy (carboplatin, cisplatin) - Chemotherapy in combination with other drugs will be assessed, e.g., in combination 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 (in order 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 for participation in the retrospective chart review study, as applicable 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 prior to initiation of first systemic therapy - Received pralsetinib as the first line of systemic therapy for RET-fusion positive NSCLC, or prior to initiation of first systemic therapy

Study Design


Locations

Country Name City State
France University Hospital Center of Toulouse - Larrey Hospital Toulouse
Switzerland Lucerne Cantonal Hospital Lucerne
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
Blueprint Medicines Corporation Analysis Group, Inc.

Countries where clinical trial is conducted

United States,  France,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparative evaluation of real-world response rate (rwORR) between patients receiving best available therapy versus pralsetinib rwORR, defined as the proportion of patients with clinician-assess complete response (CR) or partial response (PR) Up to 12 years
Secondary Comparative evaluation between patients receiving best available therapy versus pralsetinib of Overall survival (OS) OS, defined as time from initiation of a given line of therapy to death from any cause Up to 12 years
Secondary Comparative evaluation between patients receiving best available therapy versus pralsetinib of Real-world duration of response (rwDOR) rwDOR, defined as the duration of time from the first documented clinician-assessed response to the first documented clinician-assessed progressive disease or death due to any cause within 30 days of the last radiological exam, for each line of treatment Up to 12 years
Secondary Comparative evaluation between patients receiving best available therapy versus pralsetinib of Real-world disease control rate (rwDCR) rwDCR, defined as proportion of patients with clinician-assessed complete response, partial response, or stable disease Up to 12 years
Secondary Comparative evaluation between patients receiving best available therapy versus pralsetinib of Real-world clinical benefit rate (rwCBR) rwCBR, defined as proportion of patients who had documented clinician-assessed complete response or partial response, or stable disease lasting at least 16 weeks Up to 12 years
Secondary Comparative evaluation between patients receiving best available therapy versus pralsetinib of Real-world progression-free survival (rwPFS) rwPFS, defined as time from initiation of line of therapy to clinician-assessed disease progression or death from any cause, whichever occurs first Up to 12 years
Secondary Comparative evaluation between patients receiving best available therapy versus pralsetinib of Duration of treatment (DOT) DOT, defined as time from initiation of line of systemic treatment to discontinuation of same line of treatment for any reason Up to 12 years
Secondary Comparative evaluation between patients receiving best available therapy versus pralsetinib of Time to next treatment line (TtNTL) TtNTL, defined as the time from initiation of line of systemic treatment to the initiation of the next line of treatment Up to 12 years
Secondary To characterize the safety profile and conduct comparative evaluation of safety between patients receiving best available care vs. pralsetinib Adverse events (AEs) that result in treatment modification or discontinuation, hospitalization, or death according to evaluation of responsible physician Up to 12 years
See also
  Status Clinical Trial Phase
Completed NCT03826043 - THrombo-Embolic Event in Onco-hematology N/A
Terminated NCT03166631 - A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Phase 1
Completed NCT01938846 - BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors Phase 1
Recruiting NCT06058312 - Individual Food Preferences for the Mediterranean Diet in Cancer Patients N/A
Completed NCT03308942 - Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants Phase 2
Recruiting NCT06018311 - Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads N/A
Withdrawn NCT05431439 - Omics of Cancer: OncoGenomics
Completed NCT01343043 - A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma Phase 1
Completed NCT01938638 - Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer Phase 1
Recruiting NCT05514444 - Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001) Phase 1
Recruiting NCT02292641 - Beyond TME Origins N/A
Terminated NCT00954512 - Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004) Phase 1/Phase 2
Recruiting NCT04958239 - A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) Phase 1
Recruiting NCT04627376 - Multimodal Program for Cancer Related Cachexia Prevention N/A
Completed NCT01222728 - Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
Recruiting NCT06004440 - Real World Registry for Use of the Ion Endoluminal System
Active, not recruiting NCT05636696 - COMPANION: A Couple Intervention Targeting Cancer-related Fatigue N/A
Not yet recruiting NCT06035549 - Resilience in East Asian Immigrants for Advance Care Planning Discussions N/A
Recruiting NCT06004466 - Noninvasive Internal Jugular Venous Oximetry
Completed NCT02909348 - Immunophenotyping of Melanoma Patients on Treatment With Pembrolizumab