Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Sponsor

BeiGene (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04921358

Collaborator

(none)

420

Enrollment

112

Locations

Arms

35.1

Anticipated Duration (Months)

3.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of tislelizumab in combination with sitravatinib compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have disease progression following platinum-based chemotherapy and anti-programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) antibody, with the anti-PD-(L)1 antibody administered in combination with or sequentially before or after the platinum-based chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Non-Small Cell Lung Cancer (NSCLC)	Drug: Tislelizumab Drug: Docetaxel Drug: Sitravatinib	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

420 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

SAFFRON-301: A Randomized Phase 3 Study of Tislelizumab in Combination With Sitravatinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer That Progressed on or After Platinum-Based Chemotherapy and Anti-PD-(L)1 Antibody

Actual Study Start Date :

Jul 27, 2021

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A: Tislelizumab in combination with Sitravatinib tislelizumab 200 mg intravenously once every 3 weeks in combination with sitravatinib 100 mg orally once a day	Drug: Tislelizumab administered intravenously Drug: Sitravatinib administered orally
Active Comparator: Arm B: Docetaxel docetaxel 75 mg/m2 intravenously once every 3 weeks	Drug: Docetaxel administered intravenously

Arm

Intervention/Treatment

Experimental: Arm A: Tislelizumab in combination with Sitravatinib

tislelizumab 200 mg intravenously once every 3 weeks in combination with sitravatinib 100 mg orally once a day

Drug: Tislelizumab

administered intravenously

Drug: Sitravatinib

administered orally

Active Comparator: Arm B: Docetaxel

docetaxel 75 mg/m2 intravenously once every 3 weeks

Drug: Docetaxel

administered intravenously

Outcome Measures

Primary Outcome Measures

Overall survival (OS) [From first randomization up to 35 months, approximately]
OS is defined as the time from randomization to the date of death due to any reason.
Progression-free survival (PFS) as assessed by Independent Review Committee (IRC) [From first randomization up to 35 months, approximately]
defined as the time from randomization to the first occurrence of disease progression as determined by the IRC based on RECIST v1.1, or death from any cause, whichever occurs first

Secondary Outcome Measures

Progression-free survival (PFS) [From first randomization up to 35 months, approximately]
defined as the time from randomization to the first occurrence of disease progression as determined by the investigator based on RECIST v1.1, or death from any cause, whichever occurs first
Overall response rate (ORR) [From first randomization up to 35 months, approximately]
defined as the proportion of participants with partial response or complete response as determined by the IRC based on RECIST v1.1
Duration of Response (DOR) [From first randomization up to 35 months, approximately]
defined as the time from the first occurrence of a documented objective response to the time of the first occurrence of disease progression, as determined by the IRC based on RECIST v1.1, or death from any cause, whichever occurs first
Disease control rate (DCR) [From first randomization up to 35 months, approximately]
defined as the proportion of participants whose best overall response (BOR) is complete response, partial response or stable disease as determined by the IRC based on RECIST v1.1
Health-related quality of life (HRQoL) as assessed according to the European Organization and Treatment of Cancer lung cancer module, QLQ-LC13 [From first randomization up to 35 months, approximately]
A score of 1-4 will be administrated for each item in QLQ-LC13. The higher scores will indicate the worse outcomes.
Health-related quality of life (HRQoL) as assessed according to the European Organization for Research and Treatment of Cancer (EORTC) core cancer (QLQ-C30) [From first randomization up to 35 months, approximately]
The EORTC QLQ-C30 is completed by the participant. The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best).
Health-related quality of life (HRQoL) as assessed according to the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) [From first randomization up to 35 months, approximately]
Participant-reported outcomes based on EuroQoL-Five Dimensions, Five Levels (EQ-5D-5L) for all cohorts The EQ-5D- is a generic, self-reported measure of utility that consists of a five-item descriptive system and a visual analogue scale (EQ VAS). The descriptive system has two versions, namely the 3L and 5L, both involving five health dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). In the EQ-5D-5L that will be used, participants may choose from the following five response levels: no problems=1; slight problems=2; moderate problems=3; severe problems=4; and unable to/extreme problems=5. Higher values indicate worst health.
Number of participants experiencing treatment-emergent adverse events (TEAEs) graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 [From first randomization up to 35 months, approximately]
Plasma concentration of sitravatinib [From first randomization up to 35 months, approximately]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Metastatic or unresectable locally advanced histologicallyor cytologically confirmed Non-Small Cell Lung Cancer (NCSLC), not amenable to treatment with curative intent
Able to provide archival/fresh tumor tissues for biomarker analysis to assess PD-L1 expression and other biomarkers.
No known Epidermal Growth Factor Receptor (EGFR) or B-Raf proto-oncogene (BRAF) sensitizing mutation, or anaplastic lymphoma kinase (ALK) rearrangement or ROS proto oncogene 1 (ROS1) rearrangement
Radiographic progression per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 on or after anti-PD-(L)1 containing therapy for locally advanced and unresectable or metastatic NSCLC.
No prior anticancer therapy having the same mechanism of action as sitravatinib (eg, tyrosine kinase inhibitor with a similar target profile or Vascular endothelial growth factor (VEGF)- or VEGFR inhibitor)
At least 1 measurable lesion as defined based on RECIST v1.1 by investigator

Key Exclusion Criteria:

Has received docetaxel as monotherapy or in combination with other therapies.
Squamous NSCLC with central cavitation, or NSCLC with hemoptysis (> 50 mL/day)
Participants with tumor shown by imaging to be located around important vascular structures or if the investigator determines that the tumor is likely to invade important blood vessels and may cause fatal bleeding.
Active leptomeningeal disease for metastatic NSCLC, or uncontrolled or untreated brain metastasis.
Active autoimmune diseases or history of autoimmune diseases that may relapse.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Genesis Cancer Center	Tucson	Arizona	United States	71913
2	Scripps Health	La Jolla	California	United States	92037
3	Helen F Graham Cancer Center-Christiana Care	Newark	Delaware	United States	19713
4	University Medical Center New Orleans	New Orleans	Louisiana	United States	70121
5	University of Mississippi Medical Center	Jackson	Mississippi	United States	32916
6	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198
7	Hunterdon Hematology Oncology	Flemington	New Jersey	United States	08822
8	Summit Medical Group, PA	Florham Park	New Jersey	United States	07932
9	Atlantic Health System/Morristown Medical Center	Morristown	New Jersey	United States	07960
10	Ny Cancer And Blood Specialists	Port Jefferson Station	New York	United States	11776
11	Clinical Research Alliance, Inc.	Westbury	New York	United States	11590
12	TriHealth Cancer Institute	Cincinnati	Ohio	United States	45242
13	The James Thoracic Oncology Center	Columbus	Ohio	United States	43201
14	Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43210
15	Ohio State University Hospital	Columbus	Ohio	United States	43210
16	Thomas Jefferson University Hospital - Central	Philadelphia	Pennsylvania	United States	19107
17	Charleston Oncology, P.A.	Charleston	South Carolina	United States	29414
18	Hematology/Oncology Knoxville, TN	Knoxville	Tennessee	United States	37909
19	X-Cancer/Tennessee Cancer Specialists	Knoxville	Tennessee	United States	37909
20	Brooke Army Medical Center (BAMC)	Fort Sam Houston	Texas	United States	78234
21	San Antonio Military Medical Center (SAMMC)	Fort Sam Houston	Texas	United States	78234
22	D/B/A UT Health East Hope Cancer Center	Tyler	Texas	United States	75701
23	The University of Texas Health Science Center at Tyler	Tyler	Texas	United States	75701
24	Fort Belvoir Community Hospital (Geneva Foundation)	Fort Belvoir	Virginia	United States	22060
25	Cancer Care Northwest	Spokane Valley	Washington	United States	99216
26	Blacktown Cancer and Haematology Centre	Blacktown	New South Wales	Australia	2148
27	Campbelltown Hospital	Campbelltown	New South Wales	Australia	2560
28	St George Hospital	Kogarah	New South Wales	Australia	2217
29	The Tweed Hospital	Tweed Heads	New South Wales	Australia
30	Cairns and Hinterland Hospital and Health Service	Cairns	Queensland	Australia	4870
31	Gallipoli Medical Research Foundation (Greenslopes Private Hospital)	Greenslopes	Queensland	Australia	4120
32	Cancer Research South Australia	Adelaide	South Australia	Australia	5000
33	Monash Health	Clayton	Victoria	Australia
34	St Vincent's Hospital Melbourne	East Melbourne	Victoria	Australia	3002
35	Northern Hospital	Epping	Victoria	Australia	3076
36	Sunshine Hospital, Western Health	Saint Albans	Victoria	Australia	3021
37	Pindara Private Hospital	Benowa		Australia	4217
38	Anhui Cancer Hospital aka West Branch of Anhui Province Hospital	Hefei	Anhui	China	230001
39	Beijing Cancer Center	Beijing	Beijing	China	100142
40	Peking Union Medical College Hospital - Oncology	Beijing	Beijing	China	100730
41	Beijing Cancer Hospital	Beijing	Beijing	China
42	Cancer Hospital Chinese Academy of Medical Science	Beijing	Beijing	China
43	Xinqiao Hospital Affiliated to The Army Medical University	Chongqing	Chongqing	China	400030
44	Daping Hospital, Third Military Medical University	Chongqing	Chongqing	China	400042
45	Fujian Provincial Cancer Hospital	Fuzhou	Fujian	China	350014
46	First Affiliated Hospital of Xiamen University	Xiamen	Fujian	China	361003
47	First Hospital of Lanzhou University	Lanzhou	Gansu	China	730000
48	Cancer Center of Guangzhou Medical University	Guangzhou	Guangdong	China	510059
49	Guangdong Provincial People's Hospital	Guangzhou	Guangdong	China	510080
50	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong	China	510515
51	Cancer Hospital of Shantou University Medical College - Oncology	Shantou	Guangdong	China	515031
52	Affiliated Tumor Hospital of Guangxi Medical University	Nanning	Guangxi	China	530021
53	The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi	China	530021
54	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang	China	150081
55	Henan Cancer Hospital	Zhengzhou	Henan	China	450008
56	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China	450052
57	Union Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430022
58	Tongji Hospital of Tongji Medical College Huazhong University of Science Technology	Wuhan	Hubei	China	430030
59	Hubei cancer hospital	Wuhan	Hubei	China	430070
60	The Second Xiangya Hospital central South University	Changsha	Hunan	China	410011
61	The First People's Hospital of Chenzhou	Chenzhou	Hunan	China	430407
62	The Second Hospital, University of South China	Hengyang	Hunan	China	430407
63	Nanjing First Hospital	Nanjing	Jiangsu	China	210009
64	Zhongda Hospital Southeast University	Nanjing	Jiangsu	China	210009
65	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215000
66	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China
67	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu	China	221000
68	The Second Affiliated Hospital of Nanchang University	Jiangxi	Jiangxi	China	330006
69	The First affiliated hospital of Nanchang University	Nanchang	Jiangxi	China	330006
70	The First Hospital of Jilin University	Changchun	Jilin	China	130021
71	The First Hospital of Dalian Medical University	Dalian	Liaoning	China	116044
72	Liaoning Cancer Hospital & Institute - Medical Oncology - Oncology	Shenyang	Liaoning	China	110017
73	General Hospital of Ningxia Medical University	Yinchuan	Ningxia	China
74	Jinan Central Hospital	Jinan	Shandong	China	250013
75	Shandong Cancer Hospital	Jinan	Shandong	China	250117
76	Affiliated hospital of Qingdao University	Qingdao	Shandong	China	266003
77	Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.	Shanghai	Shanghai	China	200020
78	Affiliated Zhongshan Hospital of Fudan University	Shanghai	Shanghai	China	200032
79	Huashan hospital affiliated to Fudan University	Shanghai	Shanghai	China	200040
80	West China Hospital ,Sichuan University	Chengdu	Sichuan	China	610041
81	Sichuan Cancer Hospital	Chengdu	Sichuan	China	610042
82	Tianjin Medical University General Hospital	Tianjin	Tianjin	China	300052
83	Tianjin Medical University Cancer institute & Hospital	Tianjin	Tianjin	China	300070
84	Affiliated Cancer Hospital of Xinjiang Medical University	Ürümqi	Xinjiang	China	830000
85	Yunnan Cancer Hospital	Kunming	Yunnan	China	650100
86	Sir Run Run Shaw Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310000
87	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	310022
88	Changzhou No.2 People's Hospital	Changzhou		China	213003
89	Taizhou Hospital of Zhejiang Province	Taizhou		China	317000
90	Institut de Cancérologie de l'Ouest	Angers Cedex 02		France	49055
91	Centre Hospitalier Intercommunal de Creteil	Créteil		France	94010
92	Centre Hospitalier Universitaire Limoges CHU de Limoges	Limoges		France
93	Onkologische Schwerpunktpraxis Bielefeld	Bielefeld	Nordrhein-Westfalen	Germany	33604
94	Asklepios Fachklinik Munchen-Gauting	Gauting		Germany	82131
95	Universitätsklinikum Münster Hämatologie und Onkologie	Munster		Germany	48149
96	Sana Klinikum Offenbach Gmbh	Offenbach am Main		Germany	63069
97	Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Torino	Italy	10043
98	Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi	Bologna		Italy	40138
99	Azienda Ospedaliera Universitaria San Martino	Genova		Italy
100	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano		Italy
101	IOV - Istituto Oncologico Veneto IRCCS	Padova		Italy	35128
102	Azienda Ospedaliera Universitaria Integrata Di Verona	Verona		Italy	37126
103	Jeroen Bosch Ziekenhuis - Hertogenbosch	's-Hertogenbosch		Netherlands	5223 GZ
104	Ico Badalona	Badalon	Barcelona	Spain	08013
105	Hospital Universitario Vall d'Hebrón	Barcelona		Spain	08035
106	Hospital Universitario Arnau de Vilanova	Lleida		Spain	25198
107	Hospital Universitario Gregorio Marañon	Madrid		Spain	28007
108	Hospital Universitario 12 de Octubre	Madrid		Spain
109	Hospital Regional Universitario de Malaga	Málaga		Spain	29011
110	Clinica Universidad de Navarra	Navarro		Spain
111	Hospital Universitario Virgen de la Macarena	Sevilla		Spain	41009
112	Hospital Universitario Virgen del Rocio	Sevilla		Spain	41013

Sponsors and Collaborators

BeiGene

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

BeiGene

ClinicalTrials.gov Identifier:

NCT04921358

Other Study ID Numbers:

BGB-A317-Sitravatinib-301
2022-001779-15
SAFFRON-301

First Posted:

Jun 10, 2021

Last Update Posted:

Aug 25, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Docetaxel

Study Results

No Results Posted as of Aug 25, 2022