AzTrials
AzTrials

Limited Stage Small Cell Lung CancerPhase 2NCT04952597

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

A Phase 2 study testing Ociperlimab, Tislelizumab and Concurrent Chemoradiotherapy in people with Limited Stage Small Cell Lung Cancer, run by BeiGene at 33 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Limited Stage Small Cell Lung Cancer
What is being tested?
Ociperlimab, Tislelizumab and Concurrent Chemoradiotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
33 sitesin 3 countries
Study dates
15 Jul 2021to 26 Jul 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
  • Note: Other protocol-defined Inclusion/Exclusion criteria may apply

Trial locations and contacts

33 sites in 3 countries.

33 sites in 3 countries

China27 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • The First Affiliated Hospital, Sun Yat Sen University

    Guangzhou, Guangdong, 510080

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Hanzhong Central Hospital

    Hanzhong, Shaanxi, 72300

  • Huai An First Peoples Hospital

    Huaian, Jiangsu, 223300

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250000

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650000

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu, 730050

  • Linyi Cancer Hospital

    Linyi, Shandong, 276001

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan, 637000

  • Nanjing Chest Hospital

    Nanjing, Jiangsu, 210029

  • The Tumor Hospital Affiliated to Guangxi Medical University

    Nanning, Guangxi, 530021

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

    Ningbo, Zhejiang, 315000

  • Qingdao Central Hospital

    Qingdao, Shandong, 266031

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

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

    Wuhan, Hubei, 430022

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

South Korea5 sites

  • Chungbuk National University Hospital

    Cheongju-si, Chungcheongbukdo, 28644

  • Kyungpook National University Chilgok Hospital

    Daegu, Gyeongsangbukdo, 41404

  • Cha Bundang Medical Center, Cha University

    Gyeonggido, Gyeonggi-do, 13496

  • The Catholic University of Korea, St Vincents Hospital

    Suwon, Gyeonggi-do, 16247

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

United States1 site

  • Tennessee Cancer Specialist

    Knoxville, Tennessee, 37909

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Randomized, 3-Arm, Open-Label Study to Investigate the Preliminary Efficacy and Safety of the Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Plus Tislelizumab Plus Concurrent Chemoradiotherapy in Patients With Untreated Limited-Stage Small Cell Lung Cancer

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 .

Being tested
Ociperlimab, Tislelizumab, Concurrent Chemoradiotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OciperlimabDrug

    Also called BGB-A1217

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

  • TislelizumabDrug

    Also called BGB-A317

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

  • Concurrent ChemoradiotherapyDrug

    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)

Study groups in NCT04952597
Study groupRoleWhat they receive
Arm A: Ociperlimab + TislelizumabExperimentalOciperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
Receives: Drug: Ociperlimab; Drug: Tislelizumab; Drug: Concurrent Chemoradiotherapy
Arm B: TislelizumabExperimentalTislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Receives: Drug: Tislelizumab; Drug: Concurrent Chemoradiotherapy
Arm C: Concurrent Chemoradiotherapy (cCRT)ExperimentalcCRT only for 4 cycles at the investigator's discretion
Receives: Drug: Concurrent Chemoradiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Up to approximately 2 years

Secondary outcomes (12)

  1. Complete Response Rate (CR)

    defined as the percentage of participants who had CR as assessed by the investigator per RECIST v1.1

    Measured: Up to approximately 2 years

  2. Overall Response Rate (ORR)

    defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1

    Measured: Up to approximately 2 years

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

    defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1

    Measured: Up to approximately 2 years

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

    defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1

    Measured: Up to approximately 2 years

  5. Duration of Response (DOR)

    defined as the time from the date of the first occurrence of a documented objective response to the date of documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)

    Measured: Up to approximately 2 years

  6. Overall Survival (OS) in the ITT Analysis Set

    Defined as the time from the date of randomization to the date of death due to any cause

    Measured: Up to approximately 2 years

  7. Overall Survival (OS) in the PD-L1 Analysis Set

    defined as the time from the date of randomization to the date of death due to any cause

    Measured: Up to approximately 2 years

  8. Overall Survival (OS) in the TIGIT Analysis Set

    defined as the time from the date of randomization to the date of death due to any cause

    Measured: Up to approximately 2 years

  9. Distant Metastasis-free Survival (DMFS)

    defined as the time from the date of randomization to the date of the first documented distant metastasis as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)

    Measured: Up to approximately 2 years

  10. PFS in the PD-L1 Analysis Set

    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),

    Measured: Up to approximately 2 years

  11. PFS in the TIGIT Analysis Set

    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),

    Measured: Up to approximately 2 years

  12. Number of Participants Experiencing Adverse Events (AEs)

    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.03

    Measured: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2021
  2. Study start15 Jul 2021
  3. Primary completion26 Jul 2023
  4. Study completion26 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04952597
Sponsor's protocol ID
AdvanTIG-204
Other IDs
CTR20211531, BGB-A317-A1217-204
Status last verified
Oct 2024
First submitted
28 Jun 2021
Last updated
26 Oct 2024
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ociperlimab, Tislelizumab and Concurrent Chemoradiotherapy in people with Limited Stage Small Cell Lung Cancer, run by BeiGene at 33 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in China, South Korea, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04952597, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in