Study of Ociperlimab Plus Tislelizumab Plus Chemoradiotherapy in Participants With Untreated Limited-Stage Small Cell Lung Cancer

NCT04952597 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: AdvanTIG-204CTR20211531BGB-A317-A1217-204
• Study Type: interventional
• Target: 126
• Locations: 3 countries
• Sites: 33

Brief Summary

This phase 2 trial examined whether the preliminary efficacy and safety of ociperlimab, tislelizumab, and cCRT when used in combination is expected to advance treatment options in the serious unmet medical need population of Limited-Stage Small Cell Lung Cancer (LS-SCLC) participants .

Conditions

Limited Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)

  Up to approximately 2 years

Secondary Outcomes (12)

• Complete Response Rate (CR)

  Up to approximately 2 years

• Overall Response Rate (ORR)

  Up to approximately 2 years

• Overall Response Rate (ORR) in the Programmed Death-Ligand 1 (PD-L1) Analysis Set

  Up to approximately 2 years

• Overall Response Rate (ORR) in the T Cell Immunoreceptor With Immunoglobulin and ITIM Domain (TIGIT) Analysis Set

  Up to approximately 2 years

• Duration of Response (DOR)

  Up to approximately 2 years

Study Arms (3)

Arm A: Ociperlimab + Tislelizumab

EXPERIMENTAL

Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab

Drug: Ociperlimab; Drug: Tislelizumab; Drug: Concurrent Chemoradiotherapy

Arm B: Tislelizumab

EXPERIMENTAL

Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone

Drug: Tislelizumab; Drug: Concurrent Chemoradiotherapy

Arm C: Concurrent Chemoradiotherapy (cCRT)

EXPERIMENTAL

cCRT only for 4 cycles at the investigator's discretion

Drug: Concurrent Chemoradiotherapy

Interventions

Ociperlimab DRUG

Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle

Also known as: BGB-A1217

Arm A: Ociperlimab + Tislelizumab

Tislelizumab DRUG

Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle

Also known as: BGB-A317

Arm A: Ociperlimab + Tislelizumab; Arm B: Tislelizumab

Concurrent Chemoradiotherapy DRUG

Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles. Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)

Arm A: Ociperlimab + Tislelizumab; Arm B: Tislelizumab; Arm C: Concurrent Chemoradiotherapy (cCRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer
• Has limited-stage disease (stage Tx, T1-T4, N0-3, M0; AJCC staging, 8th edition), and can be safely treated with definitive radiation doses.
• Participant has not received any prior treatment for LS-SCLC.
• Participant has measurable disease as assessed according to RECIST v1.1 that is appropriate for selection as a target lesion for repeat measurement, as determined by local site investigator/radiology review
• ECOG Performance Status ≤ 2 assessed within 7 days before the first administration of study intervention, and must have a life expectancy of ≥ 12 weeks.

You may not qualify if:

• Mixed small cell lung cancer histology. Note: mixed SCLC with the component of neuroendocrine carcinoma origin is considered eligible
• Have received surgical resection for LS-SCLC
• Any participant for whom the tumor is considered resectable by surgery or stereotactic body radiation therapy/stereotactic ablative radiotherapy should be considered ineligible
• Is expected to require any other form of antineoplastic therapy while on study.
• Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways

Sponsors & Collaborators

• BeiGene: lead

Study Sites (33)

Tennessee Cancer Specialist

Knoxville, Tennessee, 37909, United States

Location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, 730050, China

Location

The First Affiliated Hospital, Sun Yat Sen University

Guangzhou, Guangdong, 510080, China

Location

The Tumor Hospital Affiliated to Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Huai An First Peoples Hospital

Huaian, Jiangsu, 223300, China

Location

Nanjing Chest Hospital

Nanjing, Jiangsu, 210029, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

Hanzhong Central Hospital

Hanzhong, Shaanxi, 72300, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250000, China

Location

Linyi Cancer Hospital

Linyi, Shandong, 276001, China

Location

Qingdao Central Hospital

Qingdao, Shandong, 266031, China

Location

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

Location

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, 637000, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650000, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital)

Ningbo, Zhejiang, 315000, China

Location

Chungbuk National University Hospital

Cheongju-si, Chungcheongbukdo, 28644, South Korea

Location

Cha Bundang Medical Center, Cha University

Gyeonggido, Gyeonggi-do, 13496, South Korea

Location

The Catholic University of Korea, St Vincents Hospital

Suwon, Gyeonggi-do, 16247, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Kyungpook National University Chilgok Hospital

Daegu, Gyeongsangbukdo, 41404, South Korea

Location

Related Publications (1)

• Youling Gong, Qingsong Pang, Rong Yu, Zhengfei Zhu, Jiangqiong Huang, Yufeng Cheng, Diansheng Zhong, Hongbo Wu, Seung Soo Yoo, Tracy Dobbs, Zinan Bao, Yunxia Zuo, Boxian Wei, Pu Sun, You Lu; Abstract CT255: AdvanTIG-204: A phase 2, multicenter, randomized, 3-arm, open-label study investigating the preliminary efficacy and safety of ociperlimab (anti-TIGIT) + tislelizumab (anti-PD-1) + concurrent chemoradiotherapy (cCRT) in patients with untreated limited-stage small cell lung cancer (SCLC). Cancer Res 1 April 2024; 84 (7_Supplement): CT255. https://doi.org/10.1158/1538-7445.AM2024-CT255

  BACKGROUND

MeSH Terms

Interventions

tislelizumab; Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Results Point of Contact

• Title: Study Director
• Organization: BeiGene

clinicaltrials@beigene.com

+1-877-828-5568

Study Officials

• BeiGene

  Study Director

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 7, 2021
• Study Start: July 15, 2021
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: October 26, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (27); KR (5); US (1)