Advanced Non-squamous Non-small-cell Lung CancerPhase 3NSCLCNCT04416035
A Study to Compare the Similarity in Efficacy and Safety Between TRS003 and China-approved Bevacizumab® in NSCLC
A Phase 3 study testing TRS003, China-approved Bevacizumab and Carboplatin in people with Advanced Non-squamous Non-small-cell Lung Cancer, run by Zhejiang Teruisi Pharmaceutical Inc. at 11 sites in China.
Trial summary
This is a double-blind Phase 3 clinical trial evaluating the efficacy and safety of TRS003 and paclitaxel-carboplatin versus China-approved bevacizumab and paclitaxel-carboplatin in patients with unresectable, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non-squamous Non-small-cell Lung Cancer
- What is being tested?
- TRS003, China-approved Bevacizumab and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 608 participants
- Where
- 11 sitesChina
- Study dates
- 17 Aug 2020to 10 Nov 2021
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years.
- Signed and dated informed consent form.
- Willing and able to comply with all study procedures.
- Histologically or cytologically confirmed unresectable, locally advanced, recurrent, or metastatic nonsquamous NSCLC; if the tumor shows multiple histologies, the main cellular phenotype will be used. Must provide archived tumor tissue obtained within 3 years for epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) testing. If archival tissue meeting this requirement is not available, patients will undergo biopsy to be eligible for study entry.
- No previous systemic therapy targeting the primary tumor or sites of metastases. Adjuvant therapy should be completed at least 6 months prior to study entry. Patients may have received radiation therapy if this was completed at least 1 month prior to entry and if other sites of measurable disease (per RECIST v11) are present.
- At least one measurable lesion per RECIST v1.1.
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- ECOG performance status score 0 or 1.
- Life expectancy ≥ 6months.
- Adequate hepatic function as evidence by meeting all the following requirements:
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN).
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3×ULN or ALT ≤ 5 × ULN if liver metastases are present.
- Adequate renal function as evidence by meeting all the following requirements:
- Serum creatinine ≤ 1.5 × ULN and calculated creatinine clearance (CrCL) > 50 mL/min (Cockroft-Gault Equation) or estimated glomerular filtration rate (GFR) > 50 mL/min.
- Urine dipstick for proteinuria < 2+. If urine dipstick is greater than or equal to 2+, proteinuria must be less than 2 g in 24 hours or the urine protein/creatinine ratio < 2.
- Hematological function defined as:
- Platelet count ≥ 100,000/μl without transfusion within 2 weeks prior to the study screening.
- Prothrombin time, international normalized ratio or activated partial thromboplastin time < 1.5 × ULN.
- Absolute neutrophil count ≥ 1,500/μl without any medical interventional treatment within two weeks prior to the study screening (ie, granulocyte-colony stimulating factors and/or herbal remedies).
- Hemoglobin (Hb) ≥ 9 g/dl without the need for transfusion within 2 weeks prior to the study screening.
Who cannot join
- Known sensitizing EGFR mutations or ALK rearrangements.
- Squamous lung cancer, mixed small cell and non-small cell lung cancer or squamous cell-dominant adeno-squamous lung cancer.
- Tumor cavitation, invading into large blood vessels or close to large vessels (such as pulmonary artery or Superior vena cava.
- Significant thrombotic or hemorrhagic events within 6 months prior to the study screening e.g., hemoptysis > 2.5 mL of red blood, gastrointestinal bleeding, hematemesis, central nervous system hemorrhage, severe epistaxis or vaginal bleeding, etc.
- Severe cardiovascular disease, including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction and significant vascular disease (including but not limited to aneurysm requiring surgical repair or recent artery thrombosis); unstable angina pectoris, New York Heart Association (NYHA) class III or IV heart failure and uncontrollable arrhythmia within 6 months prior to entry.
- History of active gastroduodenal ulcer, abdominal fistula as well as non-gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to the study screening.
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- Central nervous system (CNS) metastases; Subjects with asymptomatic CNS metastases who are neurologically stable ≥ 4 weeks following CNS-directed therapy with no evidence of CNS disease progression ≥ 4 weeks, and on a stable or decreasing dose of corticosteroids may be eligible and should be discussed with the Medical Monitor.
- Concurrent malignancy within 5 years other than adequately treated primary cervical cancer, skin-squamous or basal cell carcinomas, prostatic cancer following radical resection that does not require therapy, prostate cancer treated with active surveillance, ductal carcinoma in situ of the breast, or < T1 urothelial carcinoma.
- Uncontrolled hypertension (systolic blood pressure >150 mmHg and diastolic blood pressure >100 mmHg at the study screening), or a history of hypertension crisis or hypertensive encephalophy.
- Active hepatitis B or hepatitis C virus. Patients with evidence of infection with hepatitis B who have an undetectable viral load are eligible for study entry. Patients with evidence of infection with hepatitis C should have completed curative therapy.
- Known to be positive for human immunodeficiency virus (HIV) and with an AIDS defining opportunistic infection within 12 months of study entry or a CD4 T cell count < 359 cells/μL.
- Full dose anticoagulants, including oral or parenteral; Low dose anti-coagulation (not intended to achieve a therapeutic INR) for port patency is permitted. No Factor Xa inhibitors. No aspirin or other nonsteroidal anti-inflammatory drugs that can inhibit platelet within ten days prior to screening. No history of hemorrhagic or thrombotic disorders (e.g., hemophilia, protein C deficiency).
- Thoracic radiotherapy within 4 weeks prior to screening or palliative radiotherapy for metastasis outside thoracic region within 2 weeks prior to screening.
- Any major surgical procedure within 28 days prior to screening or anticipated elective surgery during the study. Any minor surgery such as deep vein catheterization within 48 hours prior to the first dose of the study drugs.
- Evidence of pericardial or pleural effusion or ascites that requires intervention.
- Treatment history of monoclonal antibodies or small molecule inhibitors against vascular endothelial growth factor (VEGF) or its receptor (VEGFR), including bevacizumab.
- Clinically uncontrolled active infection requiring systemic therapy within 2 weeks prior to entry.
- Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products.
- Participation in any other clinical trial within 4 weeks prior to screening. Recipient of any anticancer therapy (other than hormones used to treat breast cancer) within 4 weeks prior to screening.
- Women of childbearing potential who are pregnant or is breast feeding or who do not consent to use highly effective methods of birth control during treatment and for an additional 120 days after the last administration of the protocol specified treatment.
- Men with a partner of childbearing potential who does not consent to use highly effective methods of birth control during treatment and for an additional 120 days after the last administration of the protocol specified treatment.
- Any condition that the Investigator or primary physician believes may not be appropriate for participating the study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites, 11 recruiting
- Recruiting
Chinese Academy of Medical Sciences, Cancer Hospital
Beijing, Beijing Municipality, 100021
Yuankai Shi, MD, 13701251865
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality
Yanming Li
- Recruiting
FAW General Hospital of Jilin Province
Changchun, Jilin
Libo Liu
- Recruiting
Anhui Provincial Center Hospital
Hefei, Anhui
Changlu Hu
- Recruiting
Jinan Central Hospital
Jinan, Shandong
Chunyan Xing
- Recruiting
Nanchong Central Hospital
Nanchong, Sichuan
Xin Hu
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality
Zhongliang Guo
- Recruiting
Shanghai Fifth People's Hospital, Fudan University
Shanghai, Shanghai Municipality
Zhijun Jie
- Recruiting
The Second Affiliated Hospital of Suzhou University
Suzhou, Jiangsu
Zhixiang Zhuang
- Recruiting
Wuhan Fourth Hospital
Wuhan, Hubei
Gang Feng
- Recruiting
The Second Affiliated Hospital of Xingtai Medical College
Xingtai, Hebei
Kaoshan Guo
About this study
Official title: A Phase 3, Multicenter, Randomized and Double-Blind Study to Assess the Similarity in Efficacy and Safety Between TRS003 and China-approved Bevacizumab in Subjects With Advanced Nonsquamous NSCLC
This is a double-blind Phase 3 clinical trial evaluating the efficacy and safety of TRS003 and paclitaxel-carboplatin versus China-approved bevacizumab and paclitaxel-carboplatin in patients with unresectable, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC). Approximately 608 patients will be enrolled in this study from America, Europe, and Asia. Patients who sign the informed consent and meet the inclusion criteria, will be randomized (1:1) to receive either TRS003 in combination with paclitaxel and carboplatin or China-approved bevacizumab in combination with paclitaxel and carboplatin for 4 to 6 cycles.
Read the detailed description
This is a randomized, double-blind, multinational, multicenter, active-control, parallel two-group Phase 3 clinical trial evaluating the efficacy and safety of TRS003 plus paclitaxel-carboplatin versus China-approved bevacizumab plus paclitaxel-carboplatin in patients with unresectable, locally advanced, recurrent or metastatic non-squamous NSCLC. Approximately 608 subjects will be enrolled into this study from America, Europe and Asia. Patients who sign the informed consent and meet the inclusion criteria will be randomized (1:1) to receive either TRS003 or China-approved bevacizumab in combination with paclitaxel-carboplatin for 4 to 6 cycles. Patients will be stratified by region (Asia, Europe and America), gender, and cigarette smoking habit (previous smoker, smoker and non-smoker).
Patients will receive either TRS003 (Arm A), or China-approved bevacizumab (Arm B) first followed by the administration of paclitaxel and carboplatin. TRS003 or China-approved bevacizumab will be administered at 15 mg/kg by intravenous (IV) infusion on Day 1 of each cycle (every 3 weeks, Q3W). Paclitaxel will be administered at a dose of 200 mg/m^2 by IV infusion (over 3 hours) Q3W on Day 1 of each cycle and carboplatin will be administered at an area under the plasma concentration-time curve (AUC) 6 mg/mL/ min (the maximum dose capped at 900 mg) by IV infusion (over 15 - 30 minutes) Q3W on Day 1 of each cycle. Each cycle is 3 weeks. Treatments will continue until disease progression, death, intolerable toxicity, withdrawal of consent, investigator decision, or completion of 4-6 cycles of therapy. Maintenance therapy may be given at the discretion of the patient's primary oncologist.
Efficacy will be evaluated by the investigator per RECIST v1.1 (Eisenhauer et al., 2009). Efficacy evaluation will be performed at baseline and every 6 weeks ± 7 days during the 4-6 cycle combination treatment periods. After completion of combination treatments, efficacy evaluations will be performed every 9 weeks ± 7 days (if patients received maintenance therapy). The analysis of Investigator-determined objective response rate (ORR) (RECIST v1.1) will be based on information obtained prior to Week 19. Investigator-determined duration of response (DOR) and progression-free survival (PFS) will also be evaluated according to RECIST v1.1. Data on overall survival (OS) will be collected. Central radiology review will not be required. However, for the purpose of quality control, the Sponsor may elect to have some or all tumor assessments to be reviewed by an independent imaging vendor.
Safety will be evaluated throughout the study. Adverse events will be recorded from the time of informed consent. Safety will be assessed based on periodically physical examination findings, vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, laboratory variables (hematology, coagulation tests, serum chemistries, urinalysis and pregnancy tests), and electrocardiogram (ECG) findings. Adverse events and laboratories will be graded according to National Cancer Institute (NCI) CTCAE v5.0.
Immunogenicity will be assessed in all patients who received at least one dose of TRS003 or China-approved bevacizumab. Samples will be assessed for the development of antidrug antibodies to either TRS003, or China-approved bevacizumab. Neutralizing antibodies (NAb) will assessed in samples that are antidrug antibody (ADA) positive. Trough pharmacokinetics (PK) samples will be collected and will be analyzed for interpretation of immunogenicity data and exploratory analysis when needed.
- Being tested
- TRS003, China-approved Bevacizumab, Carboplatin, Paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRS003Biological
TRS003 will be administered at 15 mg/kg by IV infusion on Day 1 of each cycle (every 3 weeks, Q3W). Each cycle is 3 weeks.
China-approved BevacizumabBiological
China-approved bevacizumab will be administered at 15 mg/kg by IV infusion on Day 1 of each cycle (every 3 weeks, Q3W).Each cycle is 3 weeks.
CarboplatinDrug
Carboplatin will be administered at an AUC 6 mg/mL/ min (the maximum dose capped at 900 mg) by IV infusion (over 15 - 30 minutes) Q3W on Day 1 of each cycle.
PaclitaxelDrug
Paclitaxel will be administered at a dose of 200 mg/m^2 by IV infusion (over 3 hours) Q3W on Day 1 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| TRS003 | Experimental | TRS003 will be administered at 15 mg/kg by IV infusion on Day 1 of each cycle (every 3 weeks, Q3W). Paclitaxel will be administered at a dose of 200 mg/m^2 by IV infusion Q3W on Day 1 of each cycle，carboplatin will be administered at an AUC 6 mg/mL/ min by IV infusion Q3W on Day 1 of each cycle. Each cycle is 3 weeks. Treatments will continue until disease progression, death, intolerable toxicity, withdrawal of consent, investigator decision, or completion of 4-6 cycles of therapy. Maintenance therapy may be given at the discretion of the patient's primary oncologist. Receives: Biological: TRS003; Drug: Carboplatin; Drug: Paclitaxel |
| China-approved Bevacizumab | Active comparator | China-approved bevacizumab will be administered at 15 mg/kg by IV infusion on Day 1 of each cycle (every 3 weeks, Q3W). Paclitaxel will be administered at a dose of 200 mg/m^2 by IV infusion Q3W on Day 1 of each cycle and carboplatin will be administered at an AUC 6 mg/mL/min (the maximum dose capped at 900 mg) by IV infusion Q3W on Day 1 of each cycle. Each cycle is 3 weeks. Treatments will continue until disease progression, death, intolerable toxicity, withdrawal of consent, investigator decision, or completion of 4-6 cycles of therapy. Maintenance therapy may be given at the discretion of the patient's primary oncologist. Receives: Biological: China-approved Bevacizumab; Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR,Objective Response Rate
Investigator-determined confirmed ORR by Week 19 per RECIST v1.1 will be determined in the intention-to-treat (ITT) population in each arm.
Measured: 19 weeks
Secondary outcomes (8)
PFS, Progression-free survival
PFS is defined as the time from randomization to Investigator-determined progressive disease (PD) or death due to any cause in the absence of documented PD.
Measured: 19 weeks
OS, Overall survival
OS is defined as the time from randomization to death due to any cause and will be analyzed by Kaplan-Meier method.
Measured: 19 weeks
DOR, Duration of response
DOR is defined as the time from the date of the first documentation of Investigator-determined response in patients with confirmed objective tumor response (complete response or partial response) to the first documentation of Investigator determined disease progression (PD) or to death due to any cause in the absence of documented PD.
Measured: 19 weeks
Number of Participants with Treatment-Related Adverse Events (AEs)
AEs will be assigned to preferred term using MedDRA and graded according to CTCAE v5.0.
Measured: 23 weeks
Number of Participants with Immunogenicity
ADA will be assessed in all patients. NAb will be assessed in samples that are ADA positive
Measured: 23 weeks
AUC0-inf, Area Under the Serum Concentration Versus Time Curve (Time 0 to Infinity)
PK will only be analyzed for interpretation of immunogenicity data and exploratory analysis when needed.
Measured: 23 weeks
AUC0-t, Area Under the Serum Concentration Versus Time Curve (Time 0 to t)
PK will only be analyzed for interpretation of immunogenicity data and exploratory analysis when needed.
Measured: 23 weeks
Cmax, Maximum Drug Concentration
PK will only be analyzed for interpretation of immunogenicity data and exploratory analysis when needed.
Measured: 23 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start17 Aug 2020
- Primary completion21 Oct 2021 (estimated)
- Study completion10 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 608 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Teruisi Pharmaceutical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, MD, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416035
- Sponsor's protocol ID
- TRS00303001
- Acronym
- NSCLC
- Status last verified
- Aug 2020
- First submitted
- 1 Jun 2020
- Last updated
- 31 Aug 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized and Double-Blind Study to Assess the Similarity in Efficacy and Safety Between TRS003 and China-approved Bevacizumab in Subjects With Advanced Nonsquamous NSCLC
- ClinicalTrials.gov ID
- NCT04416035
- Acronym / sponsor ID
- NSCLC / TRS00303001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 608 participants (estimated)
- Lead sponsor
- Zhejiang Teruisi Pharmaceutical Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 21 Oct 2021 (estimated)
- Study completion
- 10 Nov 2021 (estimated)
- First posted
- 4 Jun 2020 (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.
This is a double-blind Phase 3 clinical trial evaluating the efficacy and safety of TRS003 and paclitaxel-carboplatin versus China-approved bevacizumab and paclitaxel-carboplatin in patients with unresectable, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC). Approximately 608 patients will be enrolled in this study from America, Europe, and Asia. Patients who sign the informed consent and meet the inclusion criteria, will be randomized (1:1) to receive either TRS003 in combination with paclitaxel and carboplatin or China-approved bevacizumab in combination with paclitaxel and carboplatin for 4 to 6 cycles.
Detailed description
This is a randomized, double-blind, multinational, multicenter, active-control, parallel two-group Phase 3 clinical trial evaluating the efficacy and safety of TRS003 plus paclitaxel-carboplatin versus China-approved bevacizumab plus paclitaxel-carboplatin in patients with unresectable, locally advanced, recurrent or metastatic non-squamous NSCLC. Approximately 608 subjects will be enrolled into this study from America, Europe and Asia. Patients who sign the informed consent and meet the inclusion criteria will be randomized (1:1) to receive either TRS003 or China-approved bevacizumab in combination with paclitaxel-carboplatin for 4 to 6 cycles. Patients will be stratified by region (Asia, Europe and America), gender, and cigarette smoking habit (previous smoker, smoker and non-smoker).
Patients will receive either TRS003 (Arm A), or China-approved bevacizumab (Arm B) first followed by the administration of paclitaxel and carboplatin. TRS003 or China-approved bevacizumab will be administered at 15 mg/kg by intravenous (IV) infusion on Day 1 of each cycle (every 3 weeks, Q3W). Paclitaxel will be administered at a dose of 200 mg/m^2 by IV infusion (over 3 hours) Q3W on Day 1 of each cycle and carboplatin will be administered at an area under the plasma concentration-time curve (AUC) 6 mg/mL/ min (the maximum dose capped at 900 mg) by IV infusion (over 15 - 30 minutes) Q3W on Day 1 of each cycle. Each cycle is 3 weeks. Treatments will continue until disease progression, death, intolerable toxicity, withdrawal of consent, investigator decision, or completion of 4-6 cycles of therapy. Maintenance therapy may be given at the discretion of the patient's primary oncologist.
Efficacy will be evaluated by the investigator per RECIST v1.1 (Eisenhauer et al., 2009). Efficacy evaluation will be performed at baseline and every 6 weeks ± 7 days during the 4-6 cycle combination treatment periods. After completion of combination treatments, efficacy evaluations will be performed every 9 weeks ± 7 days (if patients received maintenance therapy). The analysis of Investigator-determined objective response rate (ORR) (RECIST v1.1) will be based on information obtained prior to Week 19. Investigator-determined duration of response (DOR) and progression-free survival (PFS) will also be evaluated according to RECIST v1.1. Data on overall survival (OS) will be collected. Central radiology review will not be required. However, for the purpose of quality control, the Sponsor may elect to have some or all tumor assessments to be reviewed by an independent imaging vendor.
Safety will be evaluated throughout the study. Adverse events will be recorded from the time of informed consent. Safety will be assessed based on periodically physical examination findings, vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, laboratory variables (hematology, coagulation tests, serum chemistries, urinalysis and pregnancy tests), and electrocardiogram (ECG) findings. Adverse events and laboratories will be graded according to National Cancer Institute (NCI) CTCAE v5.0.
Immunogenicity will be assessed in all patients who received at least one dose of TRS003 or China-approved bevacizumab. Samples will be assessed for the development of antidrug antibodies to either TRS003, or China-approved bevacizumab. Neutralizing antibodies (NAb) will assessed in samples that are antidrug antibody (ADA) positive. Trough pharmacokinetics (PK) samples will be collected and will be analyzed for interpretation of immunogenicity data and exploratory analysis when needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRS003 | Experimental | Biological: TRS003, Drug: Carboplatin, Drug: PaclitaxelTRS003 will be administered at 15 mg/kg by IV infusion on Day 1 of each cycle (every 3 weeks, Q3W). Paclitaxel will be administered at a dose of 200 mg/m^2 by IV infusion Q3W on Day 1 of each cycle，carboplatin will be administered at an AUC 6 mg/mL/ min by IV infusion Q3W on Day 1 of each cycle. Each cycle is 3 weeks. Treatments will continue until disease progression, death, intolerable toxicity, withdrawal of consent, investigator decision, or completion of 4-6 cycles of therapy. Maintenance therapy may be given at the discretion of the patient's primary oncologist. |
| China-approved Bevacizumab | Active comparator | Biological: China-approved Bevacizumab, Drug: Carboplatin, Drug: PaclitaxelChina-approved bevacizumab will be administered at 15 mg/kg by IV infusion on Day 1 of each cycle (every 3 weeks, Q3W). Paclitaxel will be administered at a dose of 200 mg/m^2 by IV infusion Q3W on Day 1 of each cycle and carboplatin will be administered at an AUC 6 mg/mL/min (the maximum dose capped at 900 mg) by IV infusion Q3W on Day 1 of each cycle. Each cycle is 3 weeks. Treatments will continue until disease progression, death, intolerable toxicity, withdrawal of consent, investigator decision, or completion of 4-6 cycles of therapy. Maintenance therapy may be given at the discretion of the patient's primary oncologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female ≥ 18 years.
- Signed and dated informed consent form.
- Willing and able to comply with all study procedures.
- Histologically or cytologically confirmed unresectable, locally advanced, recurrent, or metastatic nonsquamous NSCLC; if the tumor shows multiple histologies, the main cellular phenotype will be used. Must provide archived tumor tissue obtained within 3 years for epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) testing. If archival tissue meeting this requirement is not available, patients will undergo biopsy to be eligible for study entry.
- No previous systemic therapy targeting the primary tumor or sites of metastases. Adjuvant therapy should be completed at least 6 months prior to study entry. Patients may have received radiation therapy if this was completed at least 1 month prior to entry and if other sites of measurable disease (per RECIST v11) are present.
Key exclusion criteria (22 listed)
- Known sensitizing EGFR mutations or ALK rearrangements.
- Squamous lung cancer, mixed small cell and non-small cell lung cancer or squamous cell-dominant adeno-squamous lung cancer.
- Tumor cavitation, invading into large blood vessels or close to large vessels (such as pulmonary artery or Superior vena cava.
- Significant thrombotic or hemorrhagic events within 6 months prior to the study screening e.g., hemoptysis > 2.5 mL of red blood, gastrointestinal bleeding, hematemesis, central nervous system hemorrhage, severe epistaxis or vaginal bleeding, etc.
- Severe cardiovascular disease, including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction and significant vascular disease (including but not limited to aneurysm requiring surgical repair or recent artery thrombosis); unstable angina pectoris, New York Heart Association (NYHA) class III or IV heart failure and uncontrollable arrhythmia within 6 months prior to entry.
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 |
|---|---|---|
| TRS003TRS003 will be administered at 15 mg/kg by IV infusion on Day 1 of each cycle (every 3 weeks, Q3W). Each cycle is 3 weeks. | Biological | TRS003 |
| China-approved BevacizumabChina-approved bevacizumab will be administered at 15 mg/kg by IV infusion on Day 1 of each cycle (every 3 weeks, Q3W).Each cycle is 3 weeks. | Biological | China-approved Bevacizumab |
| CarboplatinCarboplatin will be administered at an AUC 6 mg/mL/ min (the maximum dose capped at 900 mg) by IV infusion (over 15 - 30 minutes) Q3W on Day 1 of each cycle. | Drug | China-approved Bevacizumab, TRS003 |
| PaclitaxelPaclitaxel will be administered at a dose of 200 mg/m^2 by IV infusion (over 3 hours) Q3W on Day 1 of each cycle | Drug | China-approved Bevacizumab, TRS003 |
Primary outcome
ORR,Objective Response Rate
Time frame: 19 weeks
Investigator-determined confirmed ORR by Week 19 per RECIST v1.1 will be determined in the intention-to-treat (ITT) population in each arm.
8 secondary outcomes
PFS, Progression-free survival
Time frame: 19 weeks
OS, Overall survival
Time frame: 19 weeks
DOR, Duration of response
Time frame: 19 weeks
Number of Participants with Treatment-Related Adverse Events (AEs)
Time frame: 23 weeks
Number of Participants with Immunogenicity
Time frame: 23 weeks
AUC0-inf, Area Under the Serum Concentration Versus Time Curve (Time 0 to Infinity)
Time frame: 23 weeks
AUC0-t, Area Under the Serum Concentration Versus Time Curve (Time 0 to t)
Time frame: 23 weeks
Cmax, Maximum Drug Concentration
Time frame: 23 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
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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.
Yuankai Shi, MD principal investigator
Chinese Academy of Medical Sciences
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TRS003, China-approved Bevacizumab and Carboplatin in people with Advanced Non-squamous Non-small-cell Lung Cancer, run by Zhejiang Teruisi Pharmaceutical Inc. at 11 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 19 inclusion and 22 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 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yilin Li ((+86)5722126820, yilin.li@teruisipharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR,Objective Response Rate (time frame: 19 weeks). 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 31 Aug 2020.