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Non-Small Cell Lung CancerPhase 3NCT03594747

A Study of Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer

A Phase 3 study testing Tislelizumab, Paclitaxel and Nab-paclitaxel in people with Non-Small Cell Lung Cancer, run by BeiGene at 43 sites in China.

Completed

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

Official record
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Trial summary

An open-label, randomized, multicenter Phase 3 study designed to compare the efficacy and safety of tislelizumab combined with chemotherapy versus chemotherapy only as first-line treatment in advanced squamous non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Tislelizumab, Paclitaxel and Nab-paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
43 sitesChina
Study dates
30 Jul 2018to 28 Apr 2023
Phase
Phase 3
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75 years old, male or female, and signed informed consent form (ICF)
  • Advanced NSCLC diagnosed by pathological or clinical physicians
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
  • Participants must have ≥ 1 measurable lesion as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Must be treatment-naive for locally advanced or metastatic squamous NSCLC
  • Life expectancy ≥ 12 weeks
  • Participants must have adequate organ function
  • Male/Female is willing to use a highly effective method of birth control

Who cannot join

  • Diagnosed with NSCLC but with epidermal growth factor receptors (EGFR)-sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation
  • Received any approved systemic anticancer therapy
  • Received prior treatment with EGFR inhibitors or ALK inhibitors
  • Received prior therapies targeting programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1)
  • With history of interstitial lung disease
  • Clinically significant pericardial effusion
Show all 13Show fewer
  • Severe infections, active leptomeningeal disease or uncontrolled, untreated brain metastasis
  • Any major surgical procedure before randomization
  • Human immunodeficiency virus infection
  • Untreated hepatitis B virus (HBV)/hepatitis C virus (HCV)
  • Active autoimmune diseases or history of autoimmune diseases
  • History of allergic reactions to chemotherapy
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

China43 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Chinese Pla General Hospital

    Beijing, Beijing Municipality, 100853

  • Beijing Chest Hospital, Capital Medical University

    Beijing, Beijing Municipality, 101149

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • 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 Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010

  • Southwest Hospital

    Chongqing, Chongqing Municipality, 400038

  • Daping Hospital, Third Military Medical University

    Chongqing, Chongqing Municipality, 400042

  • Chongqing Three Gorges Central Hospital

    Chongqing, Chongqing Municipality, 404000

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Hangzhou First Peoples Hospital

    Hangzhou, Zhejiang, 310006

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230000

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250000

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • Jinan Military General Hospital

    Jinan, Shandong, 250031

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • General Hospital of Eastern Theater Command

    Nanjing, Jiangsu, 210002

  • The Peoples Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530021

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong, 515031

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Weifang Peoples Hospital

    Weifang, Shandong, 261000

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

    Wuhan, Hubei, 430022

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, Shaanxi, 710061

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • The Affiliated Hospital of Zunyi Medical College

    Zunyi, Guizhou, 563000

Other trials in China

About this study

Official title: A Phase 3, Multicenter, Randomized Open-Label Study to Compare the Efficacy and Safety of Tislelizumab (BGB A317, Anti-PD1 Antibody) Combined With Paclitaxel Plus Carboplatin or Nab Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Carboplatin Alone as First-Line Treatment for Untreated Advanced Squamous Non-small Cell Lung Cancer

An open-label, randomized, multicenter Phase 3 study designed to compare the efficacy and safety of tislelizumab combined with chemotherapy versus chemotherapy only as first-line treatment in advanced squamous non-small cell lung cancer (NSCLC).

Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • TislelizumabDrug

    Also called BGB-A317, Tevimbra

    Administered intravenously as described

  • PaclitaxelDrug

    Administered intravenously as described

  • Nab-paclitaxelDrug

    Administered intravenously as described

  • CarboplatinDrug

    Administered intravenously as described

Study groups in NCT03594747
Study groupRoleWhat they receive
Tislelizumab + Paclitaxel + CarboplatinExperimentalTislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)
Receives: Drug: Tislelizumab; Drug: Paclitaxel; Drug: Carboplatin
Tislelizumab + Nab-paclitaxel + CarboplatinExperimentalTislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days)
Receives: Drug: Tislelizumab; Drug: Nab-paclitaxel; Drug: Carboplatin
Paclitaxel + CarboplatinActive comparatorPaclitaxel 175 mg/m^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days)
Receives: Drug: Paclitaxel; Drug: Carboplatin

What is being measured

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

  1. Progression Free Survival (PFS) by Independent Review Committee (IRC) Assessment as of Data Cut-off Date of 06DEC2019

    PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first

    Measured: Through primary analysis data cut-off date of 06DEC2019 (up to approximately 1 year and 4 months)

  2. PFS by IRC Assessment as of Data Cut-off Date of 30SEP2020

    PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per RECIST v1.1 or death from any cause, whichever occurs first

    Measured: Through primary analysis data cut-off date of 30SEP2020 (up to approximately 2 years and 2 months)

Secondary outcomes (10)

  1. Overall Survival (OS)

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

    Measured: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)

  2. Objective Response Rate (ORR) by IRC Assessment

    ORR is defined as the percentage of participants with complete response (CR) and partial response (PR), as assessed by the IRC using RECIST v1.1.

    Measured: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)

  3. ORR by Investigator Assessment

    ORR is defined as the percentage of participants with complete response (CR) and partial response (PR), as assessed by the investigator using RECIST v1.1.

    Measured: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)

  4. Duration of Response (DOR) by IRC Assessment

    DOR is defined as the time from the first occurrence of a documented objective response to the time of documented disease progression assessed by the IRC using RECIST v1.1, or death from any cause, whichever comes first, in all randomized participants with documented objective responses. Data are based on number of responders.

    Measured: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)

  5. DOR by Investigator Assessment

    DOR is defined as the time from the first occurrence of a documented objective response to the time of documented disease progression assessed by the investigator using RECIST v1.1, or death from any cause, whichever comes first, in all randomized participants with documented objective responses. Data are based on number of responders.

    Measured: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)

  6. PFS by Investigator Assessment

    PFS is defined as the time from randomization until first documentation of disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurs first

    Measured: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)

  7. PFS by IRC Based on Programmed Death Ligand 1 (PD-L1) Expression

    PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per RECIST v1.1 or death from any cause, whichever occurs first, based on PD-L1 expression in tumor cells

    Measured: Through study completion data cut-off date of 28APR2023 (up to approximately 4 years and 9 months)

  8. European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13)

    Least squares mean change from baseline in EORTC QLQ-CL13 scores for chest pain, coughing, and dyspnea between tislelizumab arms and paclitaxel + carboplatin arm. The EORTC QLQ-LC13 is a questionnaire that measures lung cancer-specific disease and treatment symptoms. It includes questions about specific symptoms in which participants respond based on a 4-point scale, where 1 is "not at all" and 4 is "very much". Raw scores are transformed into a 0 to 100 scale via linear transformation. A lower score indicates an improvement in symptoms.

    Measured: Baseline to Cycle 5; each cycle is 21 days

  9. European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status

    Least squares mean change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score between tislelizumab arms and paclitaxel + carboplatin arm. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.

    Measured: Baseline to Cycle 5; each cycle is 21 days

  10. Number of Participants With Adverse Events

    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs, according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0

    Measured: From first dose to 30 days after the last dose (up to approximately 4 years and 9 months)

Timeline

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

  1. First posted20 Jul 2018
  2. Study start30 Jul 2018
  3. Primary completion30 Sep 2020
  4. Study completion28 Apr 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03594747
Sponsor's protocol ID
BGB-A317-307
Other IDs
CTR20180292
Status last verified
Oct 2024
First submitted
3 Jul 2018
Last updated
26 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Wang J, Lu S, Yu X, Hu Y, Sun Y, Wang Z, Zhao J, Yu Y, Hu C, Yang K, Feng G, Ying K, Zhuang W, Zhou J, Wu J, Leaw SJ, Zhang J, Lin X, Liang L, Yang N. Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 May 1;7(5):709-717. doi: 10.1001/jamaoncol.2021.0366.

    PubMed 33792623

  • Wang, J, S. Lu, et al. Randomized Phase III Study of Tislelizumab plus Chemotherapy versus Chemotherapy Alone as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer (Sq-NSCLC): RATIONALE-307 Updated Analysis. IOTECH Abstract, Vol. 16 Supplement 1, Dec. 2022. doi.org/10.1016/j.iotech.2022.100244.

  • Wang Z, Yu X, Zhao J, Yu Y, Wu J, Ma R, Ma Z, Cui J, Zhang J, Bao Y, Leaw S, Wang J. First-Line Tislelizumab Plus Chemotherapy for Advanced or Metastatic Squamous Non-Small Cell Lung Cancer: 4-Year Long-Term Follow-Up from RATIONALE-307. Oncol Ther. 2026 Jun;14(2):811-825. doi: 10.1007/s40487-026-00424-z. Epub 2026 Mar 11.

    PubMed 41811656

  • Duan J, Zhang Y, Chen R, Liang L, Huo Y, Lu S, Zhao J, Hu C, Sun Y, Yang K, Chen M, Yu Y, Ying J, Huang R, Ma X, Leaw S, Bai F, Shen Z, Cai S, Gao D, Wang J, Wang Z. Tumor-immune microenvironment and NRF2 associate with clinical efficacy of PD-1 blockade combined with chemotherapy in lung squamous cell carcinoma. Cell Rep Med. 2023 Dec 19;4(12):101302. doi: 10.1016/j.xcrm.2023.101302. Epub 2023 Dec 4.

    PubMed 38052215

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tislelizumab, Paclitaxel and Nab-paclitaxel in people with Non-Small Cell Lung Cancer, run by BeiGene at 43 sites in China.

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 8 inclusion and 13 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 43 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 17 Oct 2023). 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) by Independent Review Committee (IRC) Assessment as of Data Cut-off Date of 06DEC2019 (time frame: Through primary analysis data cut-off date of 06DEC2019 (up to approximately 1 year and 4 months)). The study lists 2 primary outcomes in all. 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 NCT03594747, which also lists 4 linked publications.

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.

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