Non-squamous Non-small Cell Lung CancerPhase 2NCT05394233
Tislelizumab +Bevacizumab+pc for Untreated EGFR+ and High PD-L1 Non-squamous NSCLC
A Phase 2 study testing Tislelizumab Combined With Bevacizumab and Platinum Plus Pemetrexed in people with Non-squamous Non-small Cell Lung Cancer and EGFR Gene Mutation, run by Sichuan Cancer Hospital and Research Institute at 3 sites in China.
Trial summary
A study to evaluate the efficacy and safety of tislelizumab combined with bevacizumab and platinum-based pemetrexed in the treatment of naïve patients with advanced non-squamous non-small cell lung cancer with sensitive EGFR mutations and high PD-L1 expression Prospective, open-label, single-arm phase II clinical study Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-squamous Non-small Cell Lung Cancer, EGFR Gene Mutation
- What is being tested?
- Tislelizumab Combined With Bevacizumab and Platinum Plus Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jun 2022to 1 Jun 2024
- 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
- ≥ 18 and ≤ 75 years of age. Signed the informed consent form prior to patient entry
- Histologically or pathologically confirmed non-squamous non-small cell lung cancer(NSCLC) with stage IV /III
- Patients with EGFR sensitive mutations: 19del and L858R who have not been treated with TKI for the first time, the patients need to provide the test results of the certified detection platform, and the PD-L1 expression based on tissue specimen detection is greater than 50% (PD-L1 detection clone number: SP263).
- A World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) Performance Status Score (PS) of 0 or 1 at the time of recruitment.
- Adequate organ and bone marrow function, defined as:
- Hemoglobin≥9.0 g/dL
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- Absolute neutrophil count ≥1.5 × 109/L
- Platelet count ≥100 × 109/L
- Serum bilirubin ≤ 1.5 × upper limit of normal range (ULN). This does not apply to patients diagnosed with Gilbert's syndrome (persistent or recurrent hyperbilirubinemia [primarily unconjugated bilirubin] without evidence of hemolysis or liver pathology), which may be allowed after consultation with a physician patients participating in the study.
- ALT and AST ≤2.5 × ULN
- Measured creatinine clearance (CL) >40 mL/min or Cockcroft-Gault calculated CL >40 mL/min (using actual body weight) Men: Creatinine clearance (mLmin⁄) = body weight (kg) x (140-age) 72 x serum creatinine (mg/dL) Female: creatinine clearance (mLmin⁄) = body weight (kg) x (140-age) 72 x serum creatinine (mg/dL) x 0.85
- The expected survival time of patients is ≥3 months
- Weight > 30 kg
- Have the ability to sign the informed consent form and comply with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.
Who cannot join
- Patients with grade ≥2 non-infectious pneumonia.
- History of allogeneic organ transplantation, except corneal transplantation.
- Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [except diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatous vasculitis, Graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). Exceptions to this standard include:
- Vitiligo or alopecia patients
- Patients with hypothyroidism who are stable on hormone replacement therapy (eg, after Hashimoto's syndrome)
- Any chronic skin disease that does not require systemic treatment
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- Patients without active disease within the past 5 years may be included in the study, but only after consultation with the study physician
- Patients with celiac disease that can be controlled with diet alone
- Uncontrolled concurrent diseases, including but not limited to: persistent or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active ILD , Severe chronic gastrointestinal disease with diarrhea, or a psychiatric/social condition that may limit compliance with study requirements, cause a significantly increased risk of AEs, or interfere with the subject's ability to provide written informed consent.
- History of another primary malignant tumor, except for the following cases;
- Malignant tumors with low potential risk of recurrence and no known active disease ≥5 years prior to first dose treated with curative intent
- Adequately treated non-melanoma skin cancer with no evidence of disease or lentigo maligna
- Adequately treated cervical carcinoma in situ without evidence of disease
- History of active primary immunodeficiency
- Active infection, including tuberculosis (clinical assessment, including clinical history, physical examination, radiographic findings, and tuberculosis testing consistent with local clinical practice).
- Known history of human immunodeficiency virus (HIV) infection; known active syphilis infection.
- Untreated active hepatitis B
- Hepatitis B patients who meet the following criteria are eligible for inclusion:
- Hepatitis B virus (HBV) load was below the lower limit of detection in our hospital before the first dose, and received anti-HBV therapy throughout the study period to avoid viral reactivation.
- Subjects with active hepatitis C (HCV) infection, HCV antibody positive patients only meet the study inclusion criteria when the polymerase chain reaction of HCV RNA is negative.
- Active brain metastases or spinal cord compression. Prior to study entry, all patients underwent MRI (preferred) or CT examination, preferably brain examination with intravenous contrast.
- Known allergy or hypersensitivity reaction to any study drug or any study drug excipients
- Previous exposure to immune-mediated therapy, including but not limited to: anti-PD-1, anti-PD-L1 and anti-programmed death ligand 2 (anti-PD-L2) antibodies, except for therapeutic anti-tumor vaccines .
- Live attenuated vaccine should be vaccinated within 30 days before the first dose, and live vaccine should not be vaccinated within 30 days after the last dose.
- Major surgery (as defined by the investigator) within 42 days prior to the first dose.
- Within 14 days before administration, immunosuppressive drugs are being used or have been used in the past. Exceptions to this standard include:
- Intranasal, inhaled, topical steroids, or topical steroid injections (eg, intra-articular injections)
- Systemic corticosteroid therapy not exceeding 10 mg/day of prednisone or its physiologic equivalent
- Steroids administered as prophylactic for hypersensitivity reactions (eg, prophylactic administration of CT scan)
- Pregnant or lactating female patients and fertile male or female patients are unwilling to take effective contraceptive measures from screening to 6 months after the last dose.
- Other researchers think that it is not suitable for inclusion.
- Mixed cell lung cancer: non-small cell and small cell mixed lung cancer and mixed adenosquamous lung cancer dominated by squamous cell carcinoma.
- Non-squamous non-small cell lung cancer with hemoptysis (>50 ml/day); clinically significant hemoptysis or bleeding symptoms occurred within 3 months before enrollment.
- Patients with brain metastases whose symptoms are not controlled after treatment.
- Imaging (CT/MRI) shows that the tumor lesion is less than 5 mm away from the large blood vessels, there is a central tumor that invades the local large blood vessels and is less than 2 cm away from the bronchial tree; or there is an obvious lung cavity or necrotic tumor.
- Arterial/venous thrombotic events that occurred within 12 months before enrollment
- Patients with any severe and/or uncontrolled disease (hypertension, liver cirrhosis, heart failure, etc.)
- Major surgical operation or severe traumatic injury, fracture or ulcer occurred within 4 weeks before enrollment
- Severe weight loss (greater than 10%)
- Abnormal coagulation function, with bleeding tendency or receiving thrombolytic or anticoagulation therapy
Trial locations and contacts
3 sites in 1 country.
China3 sites
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041
juan li, +8613880276636, dr.lijuan@gmail.com
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041
Sichuan Cancer Hospital
Chengdu, Sichuan
About this study
Official title: Efficacy and Safety of Tislelizumab Combined With Bevacizumab and Platinum Plus Pemetrexed for Untreated EGFR+ and High PD-L1 Expression Non-squamous NSCLC :a Phase II, Single-center, Single Arm Study
A study to evaluate the efficacy and safety of tislelizumab combined with bevacizumab and platinum-based pemetrexed in the treatment of naïve patients with advanced non-squamous non-small cell lung cancer with sensitive EGFR mutations and high PD-L1 expression Prospective, open-label, single-arm phase II clinical study
Read the detailed description
A study to evaluate the efficacy and safety of tislelizumab combined with bevacizumab and platinum-based pemetrexed in the treatment of naïve patients with advanced non-squamous non-small cell lung cancer with sensitive EGFR mutations and high PD-L1 expression Prospective, open-label, single-arm phase II clinical study;
Research purposes:
Main purpose: To evaluate the median progression-free rate of tislelizumab combined with bevacizumab and platinum pemetrexed in treatment-naïve advanced non-small cell lung cancer patients with sensitive EGFR mutations and high PD-L1 expression Survival (middle progression free survival, mPFS)
Secondary purpose:
- Evaluation of objective response rate (ORR) according to RECIST version 1.1;
- Evaluation of disease control rate (DCR) according to RECIST version 1.1;
- Assess overall survival (OS);
- Assess Duration of Response (DOR);
- Evaluate the safety of the treatment using NCI-CTCAE v5;
Exploratory Purpose:
- Assess potential predictive biomarkers.
- Being tested
- Tislelizumab Combined With Bevacizumab and Platinum Plus Pemetrexed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab Combined With Bevacizumab and Platinum Plus PemetrexedDrug
Bevacizumab: 7.5 mg/kg administered as an intravenous infusion on Day 1 of each 3-week cycle Cisplatin 75 mg/m2 will be administered as an intravenous infusion over 2 hours, every 3 weeks, Pemetrexed, 500 mg/m2, intravenously every 3 weeks, Tislelizumab, 200 mg IV every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| tislelizumab combined with bevacizumab and platinum plus pemetrexed | Experimental | Drug:
Induction Phase:
Bevacizumab: 7.5 mg/kg administered as an IV infusion on Day 1 of each 3-week cycle for 4 cycles Cisplatin 75 mg/m2 will be administered as an intravenous infusion over 2 hours every 3 weeks for 4 cycles.
Pemetrexed, 500 mg/m2, intravenously, every 3 weeks for 4 cycles
Maintenance phase:
Tislelizumab, 200 mg IV every 3 weeks;until disease progression or intolerance Bevacizumab: 7.5 mg/kg administered as an intravenous infusion on Day 1 of each 3-week cycle;until disease progression or intolerance Receives: Drug: Tislelizumab Combined With Bevacizumab and Platinum Plus Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
middle progression free survival
To evaluate the median progression-free survival (middle) of tislelizumab combined with bevacizumab and platinum-based pemetrexed in treatment-naïve advanced non-small cell lung cancer patients with sensitive EGFR mutations and high PD-L1 expression. progression free survival (mPFS)
Measured: Estimated about 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-squamous Non-small Cell Lung CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan LI, MD, Sichuan Cancer Hospital and Research Institute
- Investigators
- juan li, Study director, Sichuan Cancer Hospital Chengdu, Sichuan China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394233
- Sponsor's protocol ID
- BAT1706-LJ2022
- Status last verified
- May 2022
- First submitted
- 24 May 2022
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tislelizumab Combined With Bevacizumab and Platinum Plus Pemetrexed for Untreated EGFR+ and High PD-L1 Expression Non-squamous NSCLC :a Phase II, Single-center, Single Arm Study
- ClinicalTrials.gov ID
- NCT05394233
- Acronym / sponsor ID
- BAT1706-LJ2022
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 27 May 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.
A study to evaluate the efficacy and safety of tislelizumab combined with bevacizumab and platinum-based pemetrexed in the treatment of naïve patients with advanced non-squamous non-small cell lung cancer with sensitive EGFR mutations and high PD-L1 expression Prospective, open-label, single-arm phase II clinical study
Detailed description
A study to evaluate the efficacy and safety of tislelizumab combined with bevacizumab and platinum-based pemetrexed in the treatment of naïve patients with advanced non-squamous non-small cell lung cancer with sensitive EGFR mutations and high PD-L1 expression Prospective, open-label, single-arm phase II clinical study;
Research purposes:
Main purpose: To evaluate the median progression-free rate of tislelizumab combined with bevacizumab and platinum pemetrexed in treatment-naïve advanced non-small cell lung cancer patients with sensitive EGFR mutations and high PD-L1 expression Survival (middle progression free survival, mPFS)
Secondary purpose:
- Evaluation of objective response rate (ORR) according to RECIST version 1.1;
- Evaluation of disease control rate (DCR) according to RECIST version 1.1;
- Assess overall survival (OS);
- Assess Duration of Response (DOR);
- Evaluate the safety of the treatment using NCI-CTCAE v5;
Exploratory Purpose:
- Assess potential predictive biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tislelizumab combined with bevacizumab and platinum plus pemetrexed | Experimental | Drug: Tislelizumab Combined With Bevacizumab and Platinum Plus PemetrexedDrug: Induction Phase: Bevacizumab: 7.5 mg/kg administered as an IV infusion on Day 1 of each 3-week cycle for 4 cycles Cisplatin 75 mg/m2 will be administered as an intravenous infusion over 2 hours every 3 weeks for 4 cycles. Pemetrexed, 500 mg/m2, intravenously, every 3 weeks for 4 cycles Maintenance phase: Tislelizumab, 200 mg IV every 3 weeks;until disease progression or intolerance Bevacizumab: 7.5 mg/kg administered as an intravenous infusion on Day 1 of each 3-week cycle;until disease progression or intolerance |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- ≥ 18 and ≤ 75 years of age. Signed the informed consent form prior to patient entry
- Histologically or pathologically confirmed non-squamous non-small cell lung cancer(NSCLC) with stage IV /III
- Patients with EGFR sensitive mutations: 19del and L858R who have not been treated with TKI for the first time, the patients need to provide the test results of the certified detection platform, and the PD-L1 expression based on tissue specimen detection is greater than 50% (PD-L1 detection clone number: SP263).
- A World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) Performance Status Score (PS) of 0 or 1 at the time of recruitment.
- Adequate organ and bone marrow function, defined as:
Key exclusion criteria (40 listed)
- Patients with grade ≥2 non-infectious pneumonia.
- History of allogeneic organ transplantation, except corneal transplantation.
- Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [except diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatous vasculitis, Graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). Exceptions to this standard include:
- Uncontrolled concurrent diseases, including but not limited to: persistent or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active ILD , Severe chronic gastrointestinal disease with diarrhea, or a psychiatric/social condition that may limit compliance with study requirements, cause a significantly increased risk of AEs, or interfere with the subject's ability to provide written informed consent.
- History of another primary malignant tumor, except for the following cases;
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 Combined With Bevacizumab and Platinum Plus PemetrexedBevacizumab: 7.5 mg/kg administered as an intravenous infusion on Day 1 of each 3-week cycle Cisplatin 75 mg/m2 will be administered as an intravenous infusion over 2 hours, every 3 weeks, Pemetrexed, 500 mg/m2, intravenously every 3 weeks, Tislelizumab, 200 mg IV every 3 weeks | Drug | tislelizumab combined with bevacizumab and platinum plus pemetrexed |
Primary outcome
middle progression free survival
Time frame: Estimated about 6 months
To evaluate the median progression-free survival (middle) of tislelizumab combined with bevacizumab and platinum-based pemetrexed in treatment-naïve advanced non-small cell lung cancer patients with sensitive EGFR mutations and high PD-L1 expression. progression free survival (mPFS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- 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.
juan li study director
Sichuan Cancer Hospital Chengdu, Sichuan China
3 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 Combined With Bevacizumab and Platinum Plus Pemetrexed in people with Non-squamous Non-small Cell Lung Cancer and EGFR Gene Mutation, run by Sichuan Cancer Hospital and Research Institute at 3 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 14 inclusion and 40 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 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 juan li (+86 13880276636, dr.lijuan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
middle progression free survival (time frame: Estimated about 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2022.