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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05014815




Registration number
NCT05014815
Ethics application status
Date submitted
16/08/2021
Date registered
20/08/2021

Titles & IDs
Public title
Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Small Cell Lung Cancer
Scientific title
AdvanTIG-205: A Phase 2, Randomized Study of Ociperlimab (BGB-A1217) and Tislelizumab With Chemotherapy in Patients With Previously Untreated Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Secondary ID [1] 0 0
2021-001075-17
Secondary ID [2] 0 0
AdvanTIG-205
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC) 0 0
Nonsmall Cell Lung Cancer, Stage IV 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ociperlimab
Treatment: Drugs - Tislelizumab
Treatment: Drugs - histology-based chemotherapy
Treatment: Drugs - Placebo

Experimental: Arm A: Ociperlimab + tislelizumab histology-based chemotherapy -

Placebo comparator: Arm B: Placebo + tislelizumab + histology-based chemotherapy -


Treatment: Drugs: Ociperlimab
Ociperlimab intravenous injection

Treatment: Drugs: Tislelizumab
Tislelizumab intravenous injection

Treatment: Drugs: histology-based chemotherapy
Administered intravenously

Treatment: Drugs: Placebo
Administered as an intravenous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) as Assessed by Investigators
Timepoint [1] 0 0
Up to approximately 30 months
Secondary outcome [1] 0 0
Overall Response Rate (ORR) as Assessed by Investigators
Timepoint [1] 0 0
Up to approximately 30 months
Secondary outcome [2] 0 0
Duration of Response (DoR) As Assessed by Investigators
Timepoint [2] 0 0
Up to approximately 30 months
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Up to approximately 30 months
Secondary outcome [4] 0 0
Number of Participants Experiencing Adverse Events (AEs)
Timepoint [4] 0 0
90 days (±14) after last dose

Eligibility
Key inclusion criteria
Key

1. Histologically or cytologically documented locally advanced or recurrent NSCLC that is not eligible for curative surgery and/or definitive radiotherapy, with or without chemotherapy, or metastatic non-squamous or squamous NSCLC.
2. No prior systemic therapy for locally advanced or metastatic squamous or non-squamous NSCLC, including but not limited to chemotherapy or targeted therapy. Participants who have received prior neoadjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for nonmetastatic disease must have experienced a disease-free interval of = 6 months from the last dose of chemotherapy and/or concurrent radiotherapy prior to randomization.
3. Archival tumor tissue or fresh biopsy (if archival tissue is not available) for the determination of PD-L1 levels and retrospective analyses of other biomarkers. Only participantswho have evaluable PD-L1 results are eligible.
4. At least one measurable lesion by the investigator per RECIST v1.1.

.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status = 1.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known mutations in:

* EGFR gene Note: For non-squamous NSCLC, articipants with unknown EGFR mutation status will be required to have a tissue-based EGFR test either locally or at the central laboratory before enrollment, or endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)-based EGFR test locally. Participants found to have EGFR-sensitizing mutations will be excluded.
* ALK fusion oncogene.
* BRAF V600E
* ROS1
2. Prior treatment with EGFR inhibitors, ALK inhibitors, or targeted therapy for other driver mutations.
3. Any prior therapy targeting T-cell costimulation or checkpoint pathways in metastatic NSCLC.
4. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication = 14 days before randomization.
5. Infection (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before randomization.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
16/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
Accrual to date
Final
272
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Northern Beaches Hospital - Frenchs Forest
Recruitment hospital [2] 0 0
Port Macquarie Base Hospital - Port Macquarie,
Recruitment hospital [3] 0 0
Townsville University Hospital - Douglas
Recruitment hospital [4] 0 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [5] 0 0
Peninsula & South Eastern Hematology and Oncology Group - Frankston
Recruitment hospital [6] 0 0
Olivia Newton-John Cancer Wellness & Research Centre - Heidelberg
Recruitment postcode(s) [1] 0 0
2086 - Frenchs Forest
Recruitment postcode(s) [2] 0 0
2444 - Port Macquarie,
Recruitment postcode(s) [3] 0 0
4814 - Douglas
Recruitment postcode(s) [4] 0 0
4350 - Toowoomba
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
Nevada
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Austria
State/province [9] 0 0
Krems An Der Donau
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
China
State/province [11] 0 0
Chongqing
Country [12] 0 0
China
State/province [12] 0 0
Fujian
Country [13] 0 0
China
State/province [13] 0 0
Gansu
Country [14] 0 0
China
State/province [14] 0 0
Guangdong
Country [15] 0 0
China
State/province [15] 0 0
Heilongjiang
Country [16] 0 0
China
State/province [16] 0 0
Henan
Country [17] 0 0
China
State/province [17] 0 0
Hubei
Country [18] 0 0
China
State/province [18] 0 0
Hunan
Country [19] 0 0
China
State/province [19] 0 0
Jiangsu
Country [20] 0 0
China
State/province [20] 0 0
Liaoning
Country [21] 0 0
China
State/province [21] 0 0
Shandong
Country [22] 0 0
China
State/province [22] 0 0
Shanghai
Country [23] 0 0
China
State/province [23] 0 0
Sichuan
Country [24] 0 0
China
State/province [24] 0 0
Xinjiang
Country [25] 0 0
China
State/province [25] 0 0
Zhejiang
Country [26] 0 0
France
State/province [26] 0 0
Cedex
Country [27] 0 0
France
State/province [27] 0 0
Paris
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Gangnam-Gu
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Busan
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Gyeonggi-do
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Seoul
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Ulsan
Country [33] 0 0
Spain
State/province [33] 0 0
Austrias
Country [34] 0 0
Spain
State/province [34] 0 0
Comunidad De Valencia
Country [35] 0 0
Spain
State/province [35] 0 0
Leon
Country [36] 0 0
Spain
State/province [36] 0 0
A Coruña
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
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?
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/NCT05014815