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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05014815




Registration number
NCT05014815
Ethics application status
Date submitted
16/08/2021
Date registered
20/08/2021
Date last updated
21/05/2024

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
This is a randomized investigator and participant blinded, sponsor unblinded, multicenter
study that evaluates the safety and efficacy of ociperlimab with tislelizumab and
histology-based chemotherapy compared with treatment with tislelizumab and histology-based
chemotherapy in participants with previously untreated locally advanced, unresectable, or
metastatic NSCLC
Trial website
https://clinicaltrials.gov/ct2/show/NCT05014815
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