TislelizumabPhase 2NCT05244837

Predictive Biomarker for Efficacy and Safety of Combination of Chemotherapy and Tislelizumab in NSCLC

A Phase 2 study testing Tislelizumab 200 mg, Carboplatin AUC 5 and pemetrexed 500mg/m2 in people with Tislelizumab and Safety, run by Hao Long at 4 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

To explore the related biomarkers for safety and efficacy of the combination of chemotherapy and tislelizumab in non-small cell lung cancer Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Tislelizumab, Safety, Biomarker
What is being tested?: Tislelizumab 200 mg, Carboplatin AUC 5 and pemetrexed 500mg/m2
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 4 sitesChina
Study dates: 22 Dec 2020to Dec 2023
Phase: Phase 2
Are there results?: None posted in the registry

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

Able to provide written informed consent and able to understand and agree to comply with study requirements and evaluation forms;
Must be at least 18 years of age (or the legal age of commitment in the study occurrence jurisdiction) on the date the informed consent is signed;
At least 1 measurable lesion as defined by RECIST v1.1 criteria; Note: Target lesions must be selected to meet one of the following criteria: 1) no prior local therapy or 2) subsequent progression within the previously treated local treatment area as determined by RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
Eligible for platinum-based doublet chemotherapy;
pre-treatment tumor tissue samples for biomarker analysis can be provided;

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Adequate hematology and end-organ function as defined by the following laboratory values (≤ 7 days prior to first dose):
Patients did not require blood transfusion, platelet transfusion, or growth factor support ≤ 14 days prior to blood draw: i. Absolute neutrophil count ≥ 1.5 * 109/L ii. Platelets ≥ 100 * 109/L iii. Hemoglobin ≥ 90 g/L
Serum creatinine ≤ 1.5 × upper limit of normal (ULN), or glomerular filtration rate ≥ 60 mL/min calculated by CKD-EPI formula;
AST and ALT ≤ 2.5 times ULN, or AST and ALT ≤ 5 times ULN in patients with a documented history of liver metastases;
Serum total bilirubin ≤ 1.5 times ULN (total bilirubin must be < 3 times ULN for patients with Gilbert's syndrome)
International normalized ratio (INR) ≤ 1.5 or prothrombin time ≤ 1.5 times ULN;
Partial thromboplastin time (APTT) ≤ 1.5 × ULN;
Females of childbearing potential must agree to practice highly effective contraception for the duration of the study and for ≥ 120 days after dosing and have a negative serum pregnancy test ≤ 7 days before the first dose of study drug;
Nonsterilized men must agree to use highly effective contraception for the duration of the study and for ≥ 120 days after study drug administration;
Life expectancy greater than 3 months;
Cohort A Specific Inclusion Criteria:
Histologically confirmed Stage IIB-IIIA NSCLC (as defined by the American Joint Committee on Cancer, 8th edition);
Confirmed eligibility for R0 resection for curative intent by thoracic surgeon assessment;
Adequate cardiopulmonary function, confirmed to meet the requirement for surgical resection for curative intent;
Cohort B Specific Inclusion Criteria:
1) Histologically or cytologically confirmed locally advanced (Stage IIIA-IIIC), or metastatic (Stage IV) NSCLC not amenable to curative surgery or radiotherapy.

Who cannot join

Patients with EGFR mutation, ALK gene rearrangement or ROS1 gene rearrangement:
For patients with non-squamous cell carcinoma, if EGFR mutation status is unknown, tissue samples should be provided for local or central laboratory testing before enrollment;
For patients with squamous cell carcinoma, if EGFR mutation status is unknown, it is not required to conduct test at screening;
Testing at screening is not required if ALK gene rearrangement or ROS1 gene rearrangement status is unknown;
Allergic to any study drug or excipients;
Patients who have been treated with immune checkpoint inhibitors such as anti-PD-1, PD-L1 or CTLA-4 therapy;

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Cohort A: patients who have received systemic platinum-based doublet chemotherapy; Cohort B: patients who have received systemic platinum-based doublet chemotherapy as advanced systemic therapy;
Patients received other approved systemic anticancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin 2, and tumor necrosis factor) 4 weeks before the first dose;
Cohort B: patients with refractory pleural effusion or ascites, such as pleural effusion or ascites requiring puncture and drainage 2 before the first dose;
Cohort B: Patients with active leptomeningeal disease or brain metastasis, such as central nervous system symptoms, requiring interventional therapy (including but not limited to radiotherapy, intracranial pressure lowering therapy, etc.);
Patients with any disease requiring systemic treatment with corticosteroids (daily dose of prednisone or equivalent > 10 mg) or other immunosuppressive drugs 14 days before grouping; Note: epinephrine replacement steroids (daily dose of prednisone ≤ 10 mg or equivalent) are allowed;Inhaled corticosteroids with minimal intranasal or systemic absorption; prophylactic use of prescription corticosteroids (eg, for contrast medium allergy) for short duration (≤ 7 days) or for treatment of non-autoimmune diseases (eg, delayed hypersensitivity reaction to contact allergens) is permitted;
Active autoimmune disease or history of autoimmune disease that may recur; Note: well-controlled type 1 diabetes is allowed; hypothyroidism (controlled with thyroid hormone replacement only); well-controlled celiac disease; skin disease not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia); any other condition that is not expected to recur in the absence of an external trigger.
History of interstitial lung disease, pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease;
4. Serious infection occurred before grouping, including but not limited to hospitalization due to infectious complications, bacteremia or severe pneumonia; severe chronic or active infection (including pulmonary tuberculosis infection, etc.) requiring systemic (oral or intravenous) antibiotics within 14 days before grouping;
HBV deoxyribonucleic acid (DNA) must be < 500 IU/mL (or 2500 copies/mL) in inactive/asymptomatic carriers, patients with chronic or active hepatitis B virus (HBV) at screening Note: Patients with detectable hepatitis B surface antigen (HBsAg) or detectable HBV DNA should be treated according to treatment guidelines. Patients receiving antiviral therapy at screening should be treated > 2 weeks prior to screening.
Any major surgery requiring general anesthesia ≤ 28 before the first dose;
Presence of underlying medical conditions or alcohol/drug abuse or dependence that would impair the administration of the study drug, or that could affect the interpretation of the results, or result in a high risk of treatment complications;
Simultaneous participation in another therapeutic clinical study;
Pregnant or lactating women, or male and female patients planning to have children during the study;
Other conditions that the investigators consider inappropriate for participation in this trial, such as poor compliance.

Trial locations and contacts

4 sites in 1 country.

Long Hao, MD contact

+86-20-87343314

longhao@sysucc.org.cn

China4 sites, 2 recruiting

Guangzhou Medical University Affiliated Cancer Hospital
Guangzhou, Guangdong
Active, not recruiting
Sun Yat-sen University cancer center
Guangzhou, Guangdong
Long Hao, MD, +86-20-87343261, longhao@sysucc.org.cn
Lin Yaobin, MD
Recruiting
Guangzhou panyu central hospital
Guangzhou
Active, not recruiting
Jiangmen Central Hospital
Jiangmen, Guangdong
Lin Zhichao, MD, +86-750-3989432, linzhichao@yeah.net
Recruiting

Other trials in China

About this study

Official title: Predictive Biomarker for the Efficacy and Safety of the Combination of Chemotherapy and Tislelizumab in Non Small Cell Lung Cancer：a Multicentre Prospective Clinical Trial

To explore the related biomarkers for safety and efficacy of the combination of chemotherapy and tislelizumab in non-small cell lung cancer

Conditions: Tislelizumab, Safety, Biomarker, Chemotherapy
Being tested: Tislelizumab 200 mg, Carboplatin AUC 5, pemetrexed 500mg/m2, Paclitaxel 175mg/m2, Nab-paclitaxel 260 mg/m2

What participants receive

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

Tislelizumab 200 mgDrug
Also called Tislelizumab
Tislelizumab 200mg IV Q3W + Followed by adjuvant treatment for 1 year (Tislelizumab 200 mg IV Q3W for 2 cycles and Tislelizumab 200 mg Q4W for 12 cycles)
Carboplatin AUC 5Drug
Also called Carboplatin
Carboplatin AUC 5 IV Q3W
pemetrexed 500mg/m2Drug
Also called pemetrexed
Pemetrexed 500mg/m2 IV Q3W if non-squamous lung cancer
Paclitaxel 175mg/m2Drug
Also called Paclitaxel
Paclitaxel 175mg/m2 IV Q3W if squamous lung cancer
Nab-paclitaxel 260 mg/m2Drug
Also called Nab-paclitaxel
nab-paclitaxel 260 mg/m2 Q3W if squamous lung cancer

Study groups in NCT05244837
Study group	Role	What they receive
Arm A:Resectable Stage IIB-IIIA Non Small Cell Lung Cancer (NSCLC)	Experimental	Patients received neoadjuvant treatment with Platinum-based doublet chemotherapy plus tislelizumab(200 mg) on day 1 of each 21-day cycle, for 3-4 cycles before surgical resection, followed by adjuvant intravenous tislelizumab monotherapy for 1 year ( 200 mg every 3 weeks for 2 cycles, followed by 200 mg every 4 weeks for 12 cycles). Receives: Drug: Tislelizumab 200 mg; Drug: Carboplatin AUC 5; Drug: pemetrexed 500mg/m2; Drug: Paclitaxel 175mg/m2; Drug: Nab-paclitaxel 260 mg/m2
Arm B：Unresectable Stage IIIA/IIIB/IIIC or IV Non Small Cell Lung Cancer (NSCLC)	Experimental	Patients received neoadjuvant treatment with Platinum-based doublet chemotherapy plus tislelizumab(200 mg) on day 1 of each 21-day cycle, for 4-6 cycles , followed by adjuvant intravenous tislelizumab monotherapy ( 200 mg every 3 weeks )，until disease progression or intolerable toxicity If surgery is not possible；If surgery is possible after assessment, subsequent treatment at the discretion of the investigator Receives: Drug: Tislelizumab 200 mg; Drug: Carboplatin AUC 5; Drug: pemetrexed 500mg/m2; Drug: Paclitaxel 175mg/m2; Drug: Nab-paclitaxel 260 mg/m2

What is being measured

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

Drug safety incidents
Safety as measured by number of participants with Grade 3 and 4 lab abnormalities, as defined by CTCAE v5.0
Measured: 90 days after initial treatment of tislelizumab or 30 days post-operation, whichever is later

Secondary outcomes (4)

Evaluation of the major pathologic response (MPR)
The major pathologic response is defined as less than 10% tumor cells in the pathologically resected specimen
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 36 months
pathologic complete response
defined as no tumor cells observed in pathologically resected specimens
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first，assessed up to 36 months
Resectable rate
defined as the number of patients who underwent surgical resection/the number of randomized patients in each group
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first，assessed up to 36 months
Disease-free survival
defined as the interval from the surgery to the observation of confirmed disease recurrence
Measured: From date of randomization until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60months

Timeline

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

22 Dec 2020Dec 2023

First posted17 Feb 2022
Study start22 Dec 2020
Primary completionJul 2022 (estimated)
Study completionDec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for TislelizumabStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Non-randomised
Intervention model: Parallel groups
Model description: This study consists includes two groups, one is the treatment of patients with resectable lung cancer and the other is the treatment of patients with unresectable lung cancer.
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05244837
Sponsor's protocol ID: A2020-008
Status last verified: Feb 2022
First submitted: 31 Oct 2021
Last updated: 17 Feb 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Cao A, Lin Y, Guan S, Chen Y, Zhai W, Zhou Y, Feng S, Guan Y, Zhang Y, Huang M, Wang X, Long H. Baseline multi-omics signatures could predict therapeutic response to neoadjuvant anti-PD-1 immunochemotherapy in non-small-cell lung cancer. Clin Transl Med. 2026 Jan;16(1):e70579. doi: 10.1002/ctm2.70579.
PubMed 41499358

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Predictive Biomarker for the Efficacy and Safety of the Combination of Chemotherapy and Tislelizumab in Non Small Cell Lung Cancer：a Multicentre Prospective Clinical Trial
ClinicalTrials.gov ID: NCT05244837
Acronym / sponsor ID: A2020-008
Conditions: Tislelizumab, Safety, Biomarker, Chemotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Hao LongUniversity, hospital or other
Study start: 22 Dec 2020 (actual)
Primary completion: Jul 2022 (estimated)
Study completion: Dec 2023 (estimated)
First posted: 17 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To explore the related biomarkers for safety and efficacy of the combination of chemotherapy and tislelizumab in non-small cell lung cancer

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This study consists includes two groups, one is the treatment of patients with resectable lung cancer and the other is the treatment of patients with unresectable lung cancer.

Arm	Type	Receives
Arm A:Resectable Stage IIB-IIIA Non Small Cell Lung Cancer (NSCLC)	Experimental	Drug: Tislelizumab 200 mg, Drug: Carboplatin AUC 5, Drug: pemetrexed 500mg/m2, Drug: Paclitaxel 175mg/m2, Drug: Nab-paclitaxel 260 mg/m2Patients received neoadjuvant treatment with Platinum-based doublet chemotherapy plus tislelizumab(200 mg) on day 1 of each 21-day cycle, for 3-4 cycles before surgical resection, followed by adjuvant intravenous tislelizumab monotherapy for 1 year ( 200 mg every 3 weeks for 2 cycles, followed by 200 mg every 4 weeks for 12 cycles).
Arm B：Unresectable Stage IIIA/IIIB/IIIC or IV Non Small Cell Lung Cancer (NSCLC)	Experimental	Drug: Tislelizumab 200 mg, Drug: Carboplatin AUC 5, Drug: pemetrexed 500mg/m2, Drug: Paclitaxel 175mg/m2, Drug: Nab-paclitaxel 260 mg/m2Patients received neoadjuvant treatment with Platinum-based doublet chemotherapy plus tislelizumab(200 mg) on day 1 of each 21-day cycle, for 4-6 cycles , followed by adjuvant intravenous tislelizumab monotherapy ( 200 mg every 3 weeks )，until disease progression or intolerable toxicity If surgery is not possible；If surgery is possible after assessment, subsequent treatment at the discretion of the investigator

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

Able to provide written informed consent and able to understand and agree to comply with study requirements and evaluation forms;
Must be at least 18 years of age (or the legal age of commitment in the study occurrence jurisdiction) on the date the informed consent is signed;
At least 1 measurable lesion as defined by RECIST v1.1 criteria; Note: Target lesions must be selected to meet one of the following criteria: 1) no prior local therapy or 2) subsequent progression within the previously treated local treatment area as determined by RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
Eligible for platinum-based doublet chemotherapy;

Key exclusion criteria (20 listed)

Patients with EGFR mutation, ALK gene rearrangement or ROS1 gene rearrangement:
Allergic to any study drug or excipients;
Patients who have been treated with immune checkpoint inhibitors such as anti-PD-1, PD-L1 or CTLA-4 therapy;
Cohort A: patients who have received systemic platinum-based doublet chemotherapy; Cohort B: patients who have received systemic platinum-based doublet chemotherapy as advanced systemic therapy;
Patients received other approved systemic anticancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin 2, and tumor necrosis factor) 4 weeks before the first dose;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tislelizumab 200 mgAlso: TislelizumabTislelizumab 200mg IV Q3W + Followed by adjuvant treatment for 1 year (Tislelizumab 200 mg IV Q3W for 2 cycles and Tislelizumab 200 mg Q4W for 12 cycles)	Drug	Arm A:Resectable Stage IIB-IIIA Non Small Cell Lung Cancer (NSCLC), Arm B：Unresectable Stage IIIA/IIIB/IIIC or IV Non Small Cell Lung Cancer (NSCLC)
Carboplatin AUC 5Also: CarboplatinCarboplatin AUC 5 IV Q3W	Drug	Arm A:Resectable Stage IIB-IIIA Non Small Cell Lung Cancer (NSCLC), Arm B：Unresectable Stage IIIA/IIIB/IIIC or IV Non Small Cell Lung Cancer (NSCLC)
pemetrexed 500mg/m2Also: pemetrexedPemetrexed 500mg/m2 IV Q3W if non-squamous lung cancer	Drug	Arm A:Resectable Stage IIB-IIIA Non Small Cell Lung Cancer (NSCLC), Arm B：Unresectable Stage IIIA/IIIB/IIIC or IV Non Small Cell Lung Cancer (NSCLC)
Paclitaxel 175mg/m2Also: PaclitaxelPaclitaxel 175mg/m2 IV Q3W if squamous lung cancer	Drug	Arm A:Resectable Stage IIB-IIIA Non Small Cell Lung Cancer (NSCLC), Arm B：Unresectable Stage IIIA/IIIB/IIIC or IV Non Small Cell Lung Cancer (NSCLC)
Nab-paclitaxel 260 mg/m2Also: Nab-paclitaxelnab-paclitaxel 260 mg/m2 Q3W if squamous lung cancer	Drug	Arm A:Resectable Stage IIB-IIIA Non Small Cell Lung Cancer (NSCLC), Arm B：Unresectable Stage IIIA/IIIB/IIIC or IV Non Small Cell Lung Cancer (NSCLC)

Primary outcome

Drug safety incidents
Time frame: 90 days after initial treatment of tislelizumab or 30 days post-operation, whichever is later
Safety as measured by number of participants with Grade 3 and 4 lab abnormalities, as defined by CTCAE v5.0

4 secondary outcomes

Evaluation of the major pathologic response (MPR)
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 36 months
pathologic complete response
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first，assessed up to 36 months
Resectable rate
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first，assessed up to 36 months
Disease-free survival
Time frame: From date of randomization until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
Derived from this study: PubMed 41499358Cao A, Lin Y, Guan S, Chen Y, Zhai W, Zhou Y, Feng S, Guan Y, Zhang Y, Huang M, Wang X, Long H. Baseline multi-omics signatures could predict therapeutic response to neoadjuvant anti-PD-1 immunochemotherapy in non-small-cell lung cancer. Clin Transl Med. 2026 Jan;16(1):e70579. doi: 10.1002/ctm2.70579.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Long Hao, MD contact

+86-20-87343314

longhao@sysucc.org.cn

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab 200 mg, Carboplatin AUC 5 and pemetrexed 500mg/m2 in people with Tislelizumab and Safety, run by Hao Long at 4 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 22 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 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?

Results are not available in the source record.

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

Contact Long Hao, MD (+86-20-87343314, longhao@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Drug safety incidents (time frame: 90 days after initial treatment of tislelizumab or 30 days post-operation, whichever is later). 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 NCT05244837, 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 17 Feb 2022.