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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04222972




Registration number
NCT04222972
Ethics application status
Date submitted
3/01/2020
Date registered
10/01/2020

Titles & IDs
Public title
A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
Scientific 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
Secondary ID [1] 0 0
2019-002463-10
Secondary ID [2] 0 0
BO42864
Universal Trial Number (UTN)
Trial acronym
AcceleRET-Lung
Linked study record

Health condition
Health condition(s) or problem(s) studied:
RET-fusion Non Small Cell Lung Cancer 0 0
Lung Neoplasm 0 0
Carcinoma, Non-Small-Cell Lung 0 0
Respiratory Tract Neoplasms 0 0
Thoracic Neoplasms 0 0
Neoplasms by Site 0 0
Neoplasms 0 0
Lung Diseases 0 0
Respiratory Tract Disease 0 0
Carcinoma, Bronchogenic 0 0
Bronchial Diseases 0 0
Head and Neck Neoplasms 0 0
Adenocarcinoma 0 0
Carcinoma 0 0
Neoplasms by Histologic Type 0 0
Neoplasms, Germ Cell and Embryonal 0 0
Neoplasms, Nerve Tissue 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Head and neck
Cancer 0 0 0 0
Any cancer
Cancer 0 0 0 0
Other cancer types
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Testicular
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Pralsetinib
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Nab-Paclitaxel

Experimental: Pralsetinib - Participants randomized to the Experimental Arm will receive Pralsetinib

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)

Nonsquamous histology

* Carboplatin or cisplatin / pemetrexed (with vitamin supplementation); with optional pemetrexed (with vitamin supplementation) maintenance.
* Pembrolizumab / carboplatin or cisplatin / pemetrexed (with vitamin supplementation); followed by pembrolizumab and optional pemetrexed (with vitamin supplementation) maintenance.

Squamous histology

* Carboplatin or cisplatin / gemcitabine
* Carboplatin with paclitaxel/nab-paclitaxel and pembrolizumab


Treatment: Drugs: Pralsetinib
Administered orally

Treatment: Drugs: Carboplatin
Administered IV

Treatment: Drugs: Cisplatin
Administered IV

Treatment: Drugs: Pemetrexed
Administered IV

Treatment: Drugs: Pembrolizumab
Administered IV

Treatment: Drugs: Gemcitabine
Administered IV

Treatment: Drugs: Paclitaxel
Administered IV

Treatment: Drugs: Nab-Paclitaxel
Administered IV
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Estimated at up to 32 months
Secondary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Estimated at up to 32 months
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Estimated at approximately 32 months
Secondary outcome [3] 0 0
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [3] 0 0
Baseline, at every 21 day cycle visit until progressive disease or death (estimated 32 months)
Secondary outcome [4] 0 0
Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Timepoint [4] 0 0
Baseline, at every 21 day cycle visit until progressive disease or death (estimated 32 months)
Secondary outcome [5] 0 0
Duration of Response (DOR)
Timepoint [5] 0 0
Estimated at up to 32 months
Secondary outcome [6] 0 0
Clinical Benefit Rate (CBR)
Timepoint [6] 0 0
Estimated at up to 32 months
Secondary outcome [7] 0 0
Disease Control Rate (DCR)
Timepoint [7] 0 0
Estimated at up to 32 months

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
Accrual to date
Final
223
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital; Department of Medical Oncology - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
La Rioja
Country [4] 0 0
Belgium
State/province [4] 0 0
Edegem
Country [5] 0 0
Brazil
State/province [5] 0 0
RN
Country [6] 0 0
Brazil
State/province [6] 0 0
RS
Country [7] 0 0
Brazil
State/province [7] 0 0
SP
Country [8] 0 0
Costa Rica
State/province [8] 0 0
San José
Country [9] 0 0
France
State/province [9] 0 0
Bordeaux
Country [10] 0 0
France
State/province [10] 0 0
Boulogne Billancourt
Country [11] 0 0
France
State/province [11] 0 0
Bron
Country [12] 0 0
France
State/province [12] 0 0
Lille
Country [13] 0 0
France
State/province [13] 0 0
Marseille
Country [14] 0 0
France
State/province [14] 0 0
Paris
Country [15] 0 0
France
State/province [15] 0 0
Rennes
Country [16] 0 0
France
State/province [16] 0 0
Saint Herblain
Country [17] 0 0
France
State/province [17] 0 0
Strasbourg
Country [18] 0 0
France
State/province [18] 0 0
Toulouse cedex 9
Country [19] 0 0
France
State/province [19] 0 0
Villejuif
Country [20] 0 0
Germany
State/province [20] 0 0
Dresden
Country [21] 0 0
Germany
State/province [21] 0 0
Gauting
Country [22] 0 0
Germany
State/province [22] 0 0
Oldenburg
Country [23] 0 0
Germany
State/province [23] 0 0
Schweinfurt
Country [24] 0 0
Germany
State/province [24] 0 0
Stuttgart
Country [25] 0 0
Ireland
State/province [25] 0 0
Dublin
Country [26] 0 0
Italy
State/province [26] 0 0
Abruzzo
Country [27] 0 0
Italy
State/province [27] 0 0
Campania
Country [28] 0 0
Italy
State/province [28] 0 0
Emilia-Romagna
Country [29] 0 0
Italy
State/province [29] 0 0
Lazio
Country [30] 0 0
Italy
State/province [30] 0 0
Lombardia
Country [31] 0 0
Italy
State/province [31] 0 0
Puglia
Country [32] 0 0
Italy
State/province [32] 0 0
Toscana
Country [33] 0 0
Italy
State/province [33] 0 0
Veneto
Country [34] 0 0
Japan
State/province [34] 0 0
Aichi
Country [35] 0 0
Japan
State/province [35] 0 0
Aomori
Country [36] 0 0
Japan
State/province [36] 0 0
Ehime
Country [37] 0 0
Japan
State/province [37] 0 0
Fukuoka
Country [38] 0 0
Japan
State/province [38] 0 0
Hyogo
Country [39] 0 0
Japan
State/province [39] 0 0
Kanagawa
Country [40] 0 0
Japan
State/province [40] 0 0
Osaka
Country [41] 0 0
Japan
State/province [41] 0 0
Tokyo
Country [42] 0 0
Japan
State/province [42] 0 0
Yamaguchi
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Goyang-si
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Seoul
Country [45] 0 0
Mexico
State/province [45] 0 0
Mexico CITY (federal District)
Country [46] 0 0
Netherlands
State/province [46] 0 0
Amsterdam
Country [47] 0 0
Netherlands
State/province [47] 0 0
Groningen
Country [48] 0 0
Netherlands
State/province [48] 0 0
Maastricht
Country [49] 0 0
Norway
State/province [49] 0 0
Oslo
Country [50] 0 0
Panama
State/province [50] 0 0
Panama City
Country [51] 0 0
Poland
State/province [51] 0 0
Warszawa
Country [52] 0 0
Portugal
State/province [52] 0 0
Porto
Country [53] 0 0
Portugal
State/province [53] 0 0
Vila Nova de Gaia
Country [54] 0 0
Spain
State/province [54] 0 0
Barcelona
Country [55] 0 0
Spain
State/province [55] 0 0
Cantabria
Country [56] 0 0
Spain
State/province [56] 0 0
LA Coruña
Country [57] 0 0
Spain
State/province [57] 0 0
Madrid
Country [58] 0 0
Spain
State/province [58] 0 0
Malaga
Country [59] 0 0
Spain
State/province [59] 0 0
Zaragoza
Country [60] 0 0
Sweden
State/province [60] 0 0
Stockholm
Country [61] 0 0
Switzerland
State/province [61] 0 0
Zürich
Country [62] 0 0
Turkey
State/province [62] 0 0
Adana
Country [63] 0 0
Turkey
State/province [63] 0 0
Ankara
Country [64] 0 0
Turkey
State/province [64] 0 0
Kar?iyaka
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Cardiff
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Leicester
Country [67] 0 0
United Kingdom
State/province [67] 0 0
London
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Manchester
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04222972