A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) (AcceleRET-Lung)
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|ClinicalTrials.gov Identifier: NCT04222972|
Recruitment Status : Recruiting
First Posted : January 10, 2020
Last Update Posted : May 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Pralsetinib Drug: Carboplatin Drug: Cisplatin Drug: Pemetrexed Drug: Pembrolizumab Drug: Gemcitabine Drug: Paclitaxel Drug: Nab-Paclitaxel||Phase 3|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||226 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||July 24, 2020|
|Estimated Primary Completion Date :||September 30, 2023|
|Estimated Study Completion Date :||December 31, 2024|
Participants randomized to the Experimental Arm will receive Pralsetinib
Other Name: BLU-667
Active Comparator: Platinum-based chemotherapy with or without pembrolizumab
Participants randomized to the Active Comparator Arm will receive 1 of 6 platinum-based chemotherapy treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating Investigator (based on histology)
- Progression Free Survival (PFS) [ Time Frame: Estimated at up to 32 months ]Defined as the time from randomisation date to the first documented progressive disease (PD), as assessed by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 central imaging review or death due to any cause, whichever occurs first.
- Overall Response Rate (ORR) [ Time Frame: Estimated at up to 32 months ]Defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as assessed by BICR according to RECIST 1.1 central imaging review.
- Overall Survival (OS) [ Time Frame: Estimated at approximately 32 months ]Defined as the time from randomisation date to death due to any cause.
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline, at every 21 day cycle visit until progressive disease or death (estimated 32 months) ]The intensity of Adverse Events (AEs) will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0).
- Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS) [ Time Frame: Baseline, at every 21 day cycle visit until progressive disease or death (estimated 32 months) ]Further characterising safety and tolerability.
- Duration of Response (DOR) [ Time Frame: Estimated at up to 32 months ]Defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as assessed by BICR according to RECIST v1.1.
- Clinical Benefit Rate (CBR) [ Time Frame: Estimated at up to 32 months ]Defined as the proportion of participants who experience a best response of Stable Disease (SD) with a minimum duration of 6 months, a CR, or a PR, as assessed by BICR according to RECIST v1.1.
- Disease Control Rate (DCR) [ Time Frame: Estimated at up to 32 months ]Defined as the proportion of participants who experience a best response of CR, or PR, or SD, as assessed by BICR according to RECIST v1.1.
- European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ)-C30 Questionnaires [ Time Frame: From baseline until progressive disease or death (estimated 32 months) ]0-100 points (lower score represents worse quality of life)
- European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ)-LC13 Scores [ Time Frame: From baseline until progressive disease or death (estimated 32 months) ]The item scale ranges from 1-4 (1 = Not at all; 4 = Very Much) where the EORTC-QLQ-LC13 scoring algorithm is applied to convert to a 0-100 point scale where 100 is best quality of life (QOL), for comparability.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04222972
|Contact: Reference Study ID Number: BO42864 http://www.roche.com/about_roche/roche_worldwide.htm||888-662-6728 (U.S. and Canada)||email@example.com|
|Study Director:||Clinical Trials||Hoffmann-La Roche|