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Non-Small Cell Lung CancerPhase 3NCT03663205

A Study Evaluating the Efficacy and Safety of Tislelizumab Versus Chemotherapy in Advanced Non-Squamous Non-small Cell Lung Cancer

A Phase 3 study testing Tislelizumab, Cisplatin and Carboplatin in people with Non-Small Cell Lung Cancer, run by BeiGene at 47 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

This study evaluated the efficacy and safety of tislelizumab in combination with platinum (cisplatin or carboplatin) and pemetrexed compared with platinum and pemetrexed alone as first-line treatment in participants with Stage IIIB or IV non-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, Cisplatin and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
334 participants
Where
47 sitesChina
Study dates
23 Jul 2018to 26 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, signed informed consent form
  • Advanced NSCLC diagnosed by pathological or clinical physicians
  • Eastern Cooperative Oncology Group (ECOG) performance score ≤ 1
  • Participants must have ≥ 1 measurable lesion as defined per RECIST v1.1
  • Participants must have no prior systemic chemotherapy for advanced or metastatic 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 receptor (EGFR)-sensitizing mutation or anaplastic lymphoma kinase (ALK) gene translocation
  • Received any approved systemic anticancer therapy within 28 days prior to the initiation of study treatment
  • Received prior treatment with EGFR inhibitors or ALK inhibitors
  • Received prior therapies targeting programmed cell death protein-1 (PD-1) or programmed cell death protein ligand-1 (PD-L1)
  • With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases
  • Clinically significant pericardial effusion
Show all 13Show fewer
  • Severe infections, active leptomeningeal disease or uncontrolled, untreated brain metastasis
  • Any major surgical procedure ≤ 28 days before randomization
  • Human immunodeficiency virus (HIV) infection
  • Participants with untreated hepatitis B or C virus (HBV/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

47 sites in 1 country.

47 sites in 1 country

China47 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Chinese Pla General Hospital

    Beijing, Beijing Municipality, 100853

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Changsha Central Hospital

    Changsha, Hunan, 410004

  • 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

  • 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

  • Cancer Center of Guangzhou Medical University

    Guangzhou, Guangdong, 510030

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, 541001

  • Guizhou Cancer Hospital

    Guiyang, Guizhou, 550000

  • Hainan General Hospital

    Haikou, Hainan, 570206

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Hangzhou First Peoples Hospital

    Hangzhou, Zhejiang, 310006

  • Zhejiang University College of Medicine Second Affiliated Hospital

    Hangzhou, Zhejiang, 310009

  • 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

  • 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

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650100

  • The Peoples Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530021

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong, 515031

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042

  • The First Affiliated Hospital of Soochow University Branch Shizi

    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

  • 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, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Tislelizumab (BGB-A317) (Anti-PD1 Antibody) Combined With Platinum-Pemetrexed Versus Platinum-Pemetrexed Alone as First-line Treatment for Patients With Stage IIIB or IV Non-Squamous Non-Small Cell Lung Cancer

This study evaluated the efficacy and safety of tislelizumab in combination with platinum (cisplatin or carboplatin) and pemetrexed compared with platinum and pemetrexed alone as first-line treatment in participants with Stage IIIB or IV non-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.

Study groups in NCT03663205
Study groupRoleWhat they receive
Tislelizumab + Platinum + PemetrexedExperimentalTislelizumab 200 milligrams (mg) administered intravenously (IV) once every 3 weeks plus cisplatin 75 mg/m^2 or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
Receives: Drug: Tislelizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed
Platinum + PemetrexedActive comparatorCisplatin 75 mg/m^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days)
Receives: Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed

What is being measured

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

  1. Progression Free Survival (PFS) Assessed by Independent Review Committee (IRC) Assessment

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

    Measured: Through primary analysis data cut-off date of 23JAN2020 (up to approximately 1 year and 6 months)

Secondary outcomes (10)

  1. Objective Response Rate (ORR) by IRC Assessment

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

    Measured: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)

  2. 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, or death from any cause, whichever comes first, as assessed by the IRC using RECIST v1.1 in participants with documented objective responses

    Measured: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)

  3. 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 26APR2023 (up to approximately 4 years and 9 months)

  4. PFS by Investigator Assessment

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

    Measured: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)

  5. ORR by Investigator Assessment

    ORR is defined as the percentage of participants with CR or PR, as assessed by the investigator using RECIST v1.1

    Measured: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)

  6. 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, or death from any cause, whichever comes first, as assessed by the investigator using RECIST v1.1 in participants with documented objective responses

    Measured: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)

  7. Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13)

    Change from baseline in EORTC QLQ-CL13 scores for coughing, dyspnea, and chest pain . 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)

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

    Change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of participants with cancer. 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)

  9. 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: Through study completion data cut-off date of 26APR2023 (up to approximately 4 years and 9 months)

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

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

    Measured: Through study completion data cut-off date of 26APR2023 (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 posted10 Sep 2018
  2. Study start23 Jul 2018
  3. Primary completion23 Jan 2020
  4. Study completion26 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
334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03663205
Sponsor's protocol ID
BGB-A317-304
Other IDs
CTR20180032
Status last verified
Sep 2024
First submitted
16 Aug 2018
Last updated
4 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Lu S, Wang J, Yu Y, Yu X, Hu Y, Ai X, Ma Z, Li X, Zhuang W, Liu Y, Li W, Cui J, Wang D, Liao W, Zhou J, Wang Z, Sun Y, Qiu X, Gao J, Bao Y, Liang L, Wang M. Tislelizumab Plus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC (RATIONALE 304): A Randomized Phase 3 Trial. J Thorac Oncol. 2021 Sep;16(9):1512-1522. doi: 10.1016/j.jtho.2021.05.005. Epub 2021 May 23.

    PubMed 34033975

  • Lu S, Wang J, Yu Y, Yu X, Hu Y, Wangjun L, Li X, Liu Y, Li W, Qu X, Bao Y, Wang M. First-Line Tislelizumab Plus Chemotherapy in Advanced Non-Squamous Non-Small Cell Lung Cancer: PD-L1 >/= 50% Subgroup Analysis from the RATIONALE-304 Trial. Oncol Ther. 2025 Dec;13(4):1087-1104. doi: 10.1007/s40487-025-00378-8. Epub 2025 Sep 14.

    PubMed 40946254

  • Lu S, Yu Y, Barnes G, Qiu X, Bao Y, Tang B. Examining the Impact of Tislelizumab Added to Chemotherapy on Health-Related Quality-of-Life Outcomes in Previously Untreated Patients With Nonsquamous Non-Small Cell Lung Cancer. Cancer J. 2022 Mar-Apr 01;28(2):96-104. doi: 10.1097/PPO.0000000000000583.

    PubMed 35333492

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tislelizumab, Cisplatin and Carboplatin in people with Non-Small Cell Lung Cancer, run by BeiGene at 47 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 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 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 25 Nov 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) Assessed by Independent Review Committee (IRC) Assessment (time frame: Through primary analysis data cut-off date of 23JAN2020 (up to approximately 1 year and 6 months)). 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 NCT03663205, which also lists 3 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 4 Feb 2025.

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