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Locally Advanced or Metastatic NSCLCPhase 3NCT05990127

A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer

A Phase 3 study testing AK104, Tislelizumab and carboplatin in people with Locally Advanced or Metastatic NSCLC, run by Akeso at 62 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK104 combined chemotherapy versus Tislelizumab combined chemotherapy in first-line treatment of Locally advanced or metastatic NSCLC with PD-L1 TPS < 1%. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Locally Advanced or Metastatic NSCLC
What is being tested?
AK104, Tislelizumab and carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
642 participants
Where
62 sitesChina
Study dates
14 Nov 2023to 28 Nov 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • The subjects voluntarily participated in the study with full informed consent and signed written informed consent form.
  • Aged ≥18 years when the subject signed the informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy ≥ 3 months.
  • Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) that not amenable to complete surgical resection and not amenable to radical concurrent/sequential chemoradiation or metastatic (Stage IV) NSCLC (American Joint Committee on Cancer [AJCC] 8th edition).
  • No prior systemic therapy for advanced or metastatic NSCLC was received.
  • PD-L1 TPS < 1%.
  • No EGFR sensitive mutations or ALK gene translocation alterations.

Who cannot join

  • Histologically confirmed small cell lung cancer (SCLC).
  • NSCLC with driver gene mutations for approved targeted drug indications.
  • Active central nervous system (CNS) metastases were present.
  • Pulmonary radiation therapy > 30 Gy within 6 months prior to first dose.
  • Active malignant tumors within the past 5 years, except for tumors in this study and scured local tumors.
  • Pregnant or lactating women.
Show all 12Show fewer
  • Clinically significant cardiovascular or cerebrovascular disease.
  • Subjects with a known history of severe hypersensitivity to other monoclonal antibodies. A known history of allergy or hypersensitivity to all investigational drugs or any of their components.
  • Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment, or autoimmune diseases that may relapse or require scheduled treatment as judged by the Investigator.
  • Known active pulmonary tuberculosis.
  • Patients with active hepatitis B or active hepatitis C.
  • Known medical history of immunodeficiency or positive HIV test.

Trial locations and contacts

62 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhifang Yao, M.D. contact

+86-0760-89873999

clinicaltrials@akesobio.com

62 sites in 1 country

China62 sites

  • Affiliated hospital of Hebei university

    Baoding, Hebei, 050031

  • Cancer hospital, Chinese academy of medical sciences and Peking union medical college

    Beijing, Beijing Municipality, 100021

  • The Fifth Medical Center of the Chinese People's Liberation Army General Hospital

    Beijing, Beijing Municipality, 100039

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Beijing Chest hospital

    Beijing, Beijing Municipality, 101149

  • The first affiliated hospital of bengbu medical college

    Bengbu, Anhui, 233099

  • Binzhou medical university hospital

    Binzhou, Shandong, 256603

  • The first hospital of Jilin Universit

    Changchun, Jilin, 130061

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

  • The Second Xiangya Hospital, Central South University

    Changsha, Hunan, 410012

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Changzhi people's hospital

    Changzhi, Shanxi, 046099

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610042

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • Fujian cancer hospital

    Fuzhou, Fujian, 350014

  • First Affiliated Hospital of Gannan medical college

    Ganzhou, Jiangxi, 341000

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • Affiliated cancer hospital and institute of guangzhou medical university

    Guangzhou, Guangdong, 510095

  • Nanfang hospital

    Guangzhou, Guangdong, 510515

  • Hainan cancer hospital

    Haikou, Hainan, 570312

  • The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310005

  • Harbin medical university cancer hospital

    Harbin, Heilongjiang, 150081

  • Anhui provincial hospital

    Hefei, Anhui, 230001

  • Anhui provincial cancer hospital

    Hefei, Anhui, 230088

  • The second people's hospital of Hengshui

    Hengshui, Hebei, 053099

  • Jiamusi Tuberculosis Prevention and Control Hospital (Jiamusi Cancer Hospital)

    Jiamusi, Heilongjiang, 154007

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Yunnan Cancer Hospital /the Third Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650118

  • Gansu provincial cancer hospital

    Lanzhou, Gansu, 730050

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 450052

  • Mianyang central hospital

    Mianyang, Sichuan, 621099

  • First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Nanyang central hospital

    Nanyang, Henan, 473005

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

  • The first hospital of Qiqihar

    Qiqihar, Heilongjiang, 161005

  • Zhongshan Hospital, Fudan university

    Shanghai, Shanghai Municipality, 200032

  • The First Hospital of China medical University

    Shenyang, Liaoning, 110002

  • Liaoning cancer hospital

    Shenyang, Liaoning, 110801

  • Cancer hospital Chinses academy of medical sciences， shenzhen center

    Shenzhen, Guangdong, 518172

  • The Second Hospital of HeBei Medical University

    Shijiazhuang, Hebei, 050004

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Shanxi Cancer hospital

    Taiyuan, Shanxi, 030013

  • Tangshang people's hospital

    Tangshan, Hebei, 063001

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality, 300222

  • Tonghua Central Hospital

    Tonghua, Jilin, 134099

  • Xinjiang Medical University Cancer Hospital

    Ürümqi, Xinjiang, 830000

  • Weifang NO.2 people's Hospital

    Weifang, Shandong, 261041

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The first affiliated hospital of wannan medical college

    Wuhu, Anhui, 241001

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

  • Qinghai university affiliated hospital

    Xining, Qinghai, 810012

  • The First Affiliated Hospital of Xinxiang Medical College

    Xinxiang, Henan, 45310

  • The affiliated hospital of xuzhou medical university

    Xuzhou, Jiangsu, 221799

  • The Second People's Hospital of Yibin City

    Yibin, Sichuan, 644000

  • General hospital of ningxia medical university

    Yinchuan, Ningxia, 750003

  • Zhangzhou municipal hospital of fujian province

    Zhangzhou, Fujian, 363099

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: A Randomized, Double-blind, Phase III Trial to Compare the Efficacy and Safety of AK104 Combined With Chemotherapy to Tislelizumab Combined With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer (NSCLC)

This is a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK104 combined chemotherapy versus Tislelizumab combined chemotherapy in first-line treatment of Locally advanced or metastatic NSCLC with PD-L1 TPS < 1%.

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 NCT05990127
Study groupRoleWhat they receive
AK104 armExperimentalNot described
Receives: Drug: AK104; Drug: carboplatin; Drug: Pemetrexed; Drug: Paclitaxel
Tislelizumab armActive comparatorNot described
Receives: Drug: Tislelizumab; Drug: carboplatin; Drug: Pemetrexed; Drug: Paclitaxel

What is being measured

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

  1. Overall Survival(OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Through Database Cutoff Date (Up to approximately 39 months)

  2. Progression-Free Survival(PFS) by investigator(INV)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1

    Measured: Through Database Cutoff Date (Up to approximately 39 months)

Secondary outcomes (14)

  1. Progression-Free Survival(PFS) by Blind independent center review(BIRC)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1

    Measured: Through Database Cutoff Date (Up to approximately 39 months)

  2. Objective response rate (ORR) was assessed by INV

    ORR is the proportion of subjects with CR or PR based on RECIST v1.1

    Measured: Through Database Cutoff Date (Up to approximately 39 months)

  3. Disease control rate (DCR) was assessed by INV

    Disease control rate (DCR) was assessed based on RECIST V1.1 criteria

    Measured: Through Database Cutoff Date (Up to approximately 39 months)

  4. Time to response (TTR) was assessed by INV

    The time from the first administration to the date of documented CR or PR

    Measured: Through Database Cutoff Date (Up to approximately 39 months)

  5. Duration of response (DOR) was assessed by INV

    Measured from the date of partial or complete response to therapy until the disease progression per RECIST v1.1 criteria

    Measured: Through Database Cutoff Date (Up to approximately 39 months)

  6. Objective response rate (ORR) was assessed by BIRC

    ORR is the proportion of subjects with CR or PR based on RECIST v1.1

    Measured: Through Database Cutoff Date (Up to approximately 39 months)

  7. Disease control rate (DCR) was assessed BIRC

    Disease control rate (DCR) was assessed based on RECIST V1.1 criteria

    Measured: Through Database Cutoff Date (Up to approximately 39 months)

  8. Time to response (TTR) was assessed by BIRC

    The time from the first administration to the date of documented CR or PR

    Measured: Through Database Cutoff Date (Up to approximately 39 months)

  9. Duration of response (DOR) was assessed by BIRC

    Measured from the date of partial or complete response to therapy until the disease progression per RECIST v1.1 criteria

    Measured: Through Database Cutoff Date (Up to approximately 39 months)

  10. The number of subjects experiencing adverse events (AEs)

    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results.

    Measured: Through Database Cutoff Date (Up to approximately 39 months)

  11. Pharmacokinetic

    The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration

    Measured: Through Database Cutoff Date (Up to approximately 39 months)

  12. Antidrug antibodies (ADA) of AK104

    Proportion of subjects who develop detectable anti-drug antibodies (ADAs)

    Measured: Through Database Cutoff Date (Up to approximately 39 months)

  13. Health-related Quality of Life (HRQoL) assessment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

    EORTC QLQ-C30 measures cancer patients' physical, psychological, and social functions. Scale ranges from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much". Higher score for the functioning scales and global health status denotes a better level of functioning, while higher scores on the symptom and single-item scales indicate a higher level of symptoms.

    Measured: Through Database Cutoff Date (Up to approximately 39 months)

  14. Health-related Quality of Life (HRQoL) assessment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 29 module (EORTC QLQ-LC29)

    EORTC-QLQ-LC29 measures the quality of life in patients with lung cancer. Symptom scale ranges from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much". For symptoms scales, higher scores indicated greater symptom burden.

    Measured: Through Database Cutoff Date (Up to approximately 39 months)

Timeline

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

  1. First posted14 Aug 2023
  2. Study start14 Nov 2023 (estimated)
  3. Primary completion5 Aug 2025 (estimated)
  4. Study completion28 Nov 2026 (estimated)

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
642 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05990127
Sponsor's protocol ID
AK104-307
Status last verified
Aug 2023
First submitted
3 Aug 2023
Last updated
14 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AK104, Tislelizumab and carboplatin in people with Locally Advanced or Metastatic NSCLC, run by Akeso at 62 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 12 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: opening soon, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Zhifang Yao, M.D. (+86-0760-89873999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival(OS) (time frame: Through Database Cutoff Date (Up to approximately 39 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 NCT05990127.

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 14 Aug 2023; AzTrials last refreshed its copy on 26 Oct 2026.

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