Clinical trial NCT05635708: A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer
Official title: Master Protocol: A Phase 2, Open-label, Multi-arm Study of Tislelizumab in Combination With Investigational Agents With or Without Chemotherapy in Patients With Previously Untreated, Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Metastatic Non-small Cell Lung Cancer
Keywords: Non-small Cell Lung Cancer
NSCLC
programmed cell death protein-1
PD-L1 Low Tumors
PD-L1 Negative Tumors
Metastatic Non-Small Cell Lung Cancer
PD-L1 High Tumors
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2022-12-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the antitumor activity, safety, and tolerability of tislelizumab plus investigational agent(s) with or without chemotherapy. This study is structured as a master protocol with separate sub- studies. Sub-study 1 includes participants with non-small cell lung cancer (NSCLC) with high programmed cell death protein ligand-1 (PD-L1) expression (≥ 50%), and Sub-study 2 includes participants with NSCLC with low or negative (PD-L1) expression (\< 50%).


Eligibility criteria: Key Inclusion Criteria:

1. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including nonsquamous or squamous subtypes, that is either locally advanced or recurrent and not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic NSCLC.
2. No prior systemic therapy administered as the primary treatment for metastatic NSCLC. Prior adjuvant or neoadjuvant chemotherapy, definitive chemoradiation, or adjuvant radiotherapy for locally advanced disease is permitted, provided the last dose of chemotherapy and/or radiotherapy occurred at least 6 months prior to randomization/enrollment.
3. Tumor programmed death-ligand 1 (PD-L1) expression must be evaluable, as determined by a local or central laboratory using archival tumor tissue or a fresh biopsy. Participants with unknown PD-L1 expression are not eligible.
4. At least one measurable lesion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Key Exclusion Criteria:

1. Diagnosis of mixed small cell lung cancer.
2. Known genomic alterations for which effective targeted therapies are available according to local standard of care, including but not limited to:

   * Epidermal growth factor receptor (EGFR) mutations
   * Anaplastic lymphoma kinase (ALK) rearrangements
   * B-Raf proto-oncogene (BRAF) mutations
   * Rearranged during transfection (RET) fusions
   * c-ros oncogene 1 (ROS1) rearrangements
3. Participants with nonsquamous NSCLC and unknown EGFR mutation status must undergo local testing. Those found to have EGFR-sensitizing mutations will be excluded.
4. Prior treatment with immune-based therapies that target immune checkpoint pathways, including:

   * PD-1 (programmed cell death protein 1) inhibitors
   * PD-L1 (programmed death-ligand 1) inhibitors
   * PD-L2 (programmed death-ligand 2) inhibitors
   * TIGIT (T cell immunoreceptor with Ig and ITIM domains) inhibitors
   * LAG-3 (lymphocyte activation gene 3) inhibitors
5. Participants previously treated with these agents in a neoadjuvant, adjuvant, or consolidation setting may be eligible if a treatment-free interval of at least 6 months has elapsed since the last dose and radiologic evidence of recurrence is present.
6. Use of Chinese herbal medicines or Chinese patent medicines intended for cancer control within 14 days prior to randomization/enrollment.
7. Presence of active leptomeningeal disease, untreated or uncontrolled brain metastases, or active autoimmune disease.

Note: Additional protocol-defined and sub-study-specific criteria may apply.

Primary outcomes:
measure: Confirmed overall response rate (ORR)
timeFrame: Up to 6 months
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to 1 year
measure: Duration of Response (DOR)
timeFrame: Up to 1 year
measure: Clinical Benefit Rate (CBR)
timeFrame: Up to 6 months
measure: Disease Control Rate (DCR)
timeFrame: Up to 6 months
measure: Number of participants with adverse events (AEs)
timeFrame: From the first dose of study drug(s) to 90 days after initiation of new anticancer therapy, death, withdrawal of consent, or loss to follow-up, whichever occurs first, up to approximately 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Valkyrie Clinical Trials
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Presbyterian
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center Mskcc
state: New York
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Oncology and Hematology Care Clinic Westside
state: Oregon
city: Houston
country: United States
facility: The University of Texas Md Anderson Cancer Center
state: Texas
city: Blacktown
country: Australia
facility: Blacktown Cancer and Haematology Centre
state: New South Wales
city: Camperdown
country: Australia
facility: Chris Obrien Lifehouse
state: New South Wales
city: Frenchs Forest
country: Australia
facility: Northern Beaches Hospital
state: New South Wales
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital
state: New South Wales
city: Nedlands
country: Australia
facility: One Clinical Research
state: Western Australia
city: Subiaco
country: Australia
facility: St John of God Health Care
state: Western Australia
city: Barretos
country: Brazil
facility: Hospital de Amor Barretos
city: Londrina
country: Brazil
facility: Hospital Do Cancer de Londrina
city: Porto Alegre
country: Brazil
facility: Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
city: Sao Jose Do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
city: Sao Paulo
country: Brazil
facility: Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: The Fifth Medical Center of Chinese Pla General Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Nantong
country: China
facility: Nantong Tumor Hospital Branch North
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University Branch Xianghu
state: Jiangxi
city: Jining
country: China
facility: Jining No Peoples Hospital East Branch
state: Shandong
city: Linyi
country: China
facility: Linyi Peoples Hospital
state: Shandong
city: Shanghai
country: China
facility: Affiliated Zhongshan Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital Branch Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang
state: Zhejiang
city: Paris
country: France
facility: Institut Curie
city: SaintHerblain
country: France
facility: Chu Nantes Hopital Nord Laennec
city: Tbilisi
country: Georgia
facility: Arensia Exploratory Medicine Llc
city: Roma
country: Italy
facility: Regina Elena, Istituto Nazionale Dei Tumori, Ifo, Irccs
city: Verona
country: Italy
facility: Centro Ricerche Cliniche Di Verona
city: SeowonGu CheongjuSi
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbukdo
city: BundangGu SeongnamSi
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: IlsandongGu GoyangSi
country: Korea, Republic of
facility: National Cancer Center (Korea)
state: Gyeonggi-do
city: PaldalGu SuwonSi
country: Korea, Republic of
facility: The Catholic University of Korea, St Vincents Hospital
state: Gyeonggi-do
city: GangnamGu
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul Teugbyeolsi
city: SeodaemunGu
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
state: Seoul Teugbyeolsi
city: SongpaGu
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul Teugbyeolsi
city: Georgetown
country: Malaysia
facility: Pulau Pinang Hospital
city: Johor Bahru
country: Malaysia
facility: Sultan Ismail Hospital
city: Kuantan
country: Malaysia
facility: Tengku Ampuan Afzan Hospital
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Petaling Jaya
country: Malaysia
facility: Beacon Hospital
city: Chisinau
country: Moldova, Republic of
facility: The Institute of Oncology, Arensia Exploratory Medicine
city: Bucureti
country: Romania
facility: Institute of Oncology Bucharest Prof Dr Alexandru Trestioreanu
city: ClujNapoca
country: Romania
facility: Arensia Research Clinic At the Oncology Institute Prof Dr Ion Chiricu
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Barcelona
country: Spain
facility: Hospital Universitario Vall Dhebron
city: Madrid
country: Spain
facility: Hospital Universitario de Octubre
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Hat Yai
country: Thailand
facility: Songklanagarind Hospital (Prince of Songkhla University)
city: Muang
country: Thailand
facility: Srinagarind Hospital (Khon Kaen University)
city: Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)
city: Ongkharak
country: Thailand
facility: Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: