Advanced Non-squamous Non-small Cell Lung CancerNCT04137588
Efficacy and Safety of Use of Platinum Based Doublet Chemotherapy Plus Antiangiogenesis and Immune Checkpoint Inhibitors in Patients With Advanced Non-squamous Non-small Cell Lung Cancer
An observational study of Advanced Non-squamous Non-small Cell Lung Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
The purpose of this study is to explore the efficacy and safety of Use of Platinum Based Doublet Chemotherapy Plus Antiangiogenesis and Immune Checkpoint Inhibitors in Patients With Advanced Non-squamous Non-small Cell Lung Cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Non-squamous Non-small Cell Lung Cancer
- What is being tested?
- Antiangiogenesis Agents and Immune checkpoint inhibitor
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2021to 1 Jun 2022
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Males and females, 18-75 years of age, non squamous non-small cell lung cancer, wild type genotype
Who may be able to join
- Voluntarily sign informed consent;
- Non-squamous non-small cell lung cancer, newly diagnosed or previously not treated with systemic chemotherapy and / or epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors treatment;
- Aged 18-75 years;
- Eastern Cooperative Oncology Group (ECOG) score ≤ 2;
- Survival is expected to exceed 12 weeks ;
- Patients had a wild-type genotype (WT population; patients with EGFR or ALK genetic alterations were excluded)
Who cannot join
- If any of the following criteria is met, the subject shall be excluded:
- Squamous cell carcinoma (including adenosquamous carcinoma) and small cell lung cancer (including small cell carcinoma and non-small cell mixed lung cancer);
- In the past 2 weeks, there have been systematic anti-tumor treatment including chemotherapy (including thoracic chemotherapy), radiotherapy (excluding radiotherapy of metastatic lesions outside the thoracic radiation field), targeted therapy, immunotherapy and biotherapy;
- The subject had received anti-vascular endothelial growth factor (VEGF) small molecule tyrosine kinase inhibitors or monoclonal antibodies in the past 4 weeks;
- Laboratory results:
- White blood cell count <3 × 109 / L, neutrophil count <1.5 × 109 / L, platelet <75 × 109 / L, or hemoglobin <8g / dL;
Show all 29Show fewer
- Coagulation abnormalities (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or activated partial thromboplastin time (APTT) > 1.5 ULN), with bleeding tendency or being treated with thrombolysis or anticoagulation;
- Serum total bilirubin ≥1.5 ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 ULN in the absence of liver metastases; ALT or AST ≥5 ULN in liver metastases;
- Serum albumin <30g / L;
- Serum creatinine ≥ 1.5 ULN or creatinine clearance <40ml / min; • Urine routine urinary protein ≥ ++, or 24 hours urine protein ≥ 1.0 g;
- Heart disease with significant clinical symptoms, such as: congestive heart failure, coronary heart disease with symptom, arrhythmia hardly be controlled by drugs, myocardial infarction in 6 months, or heart failure;
- Imaging (CT or MRI) showed a tumor lesion 5 mm away from the large vessels, or the presence of invasive central vasculature of the central tumor; imaging (CT or MRI) showed significant cavitation or necrosis of the lung tumor; Other diseases that may cause haemoptysis;
- Imaging (CT or chest radiograph) showed significant pneumothorax, fluid pneumothorax;
- Obvious cough blood in 6 months, or daily hemoptysis amounted to half a teaspoon (2.5ml) or more;
- Significant bleeding symptoms or with definite bleeding tendency within 12 months before randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, occult blood ++ and above, intracerebral hemorrhage, vasculitis, or with congenital or acquired coagulopathy disorders;
- Thrombosis, cancer thrombosis (including arteriovenous thrombosis, tumor thrombus, pulmonary embolism, transient ischemic attack, etc.) occurred within 12 months;
- There are gastrointestinal obstruction, peptic ulcer, Crohn's disease, ulcerative colitis and other gastrointestinal diseases or other diseases may cause gastrointestinal bleeding or perforation;
- Severe respiratory diseases, or need long-term oxygen, corticosteroid treatment of diseases such as chronic obstructive pulmonary disease, interstitial lung disease and respiratory failure;
- Patients with uncontrolled central nervous system metastasis;
- There are serious uncontrolled systemic diseases, such as nephrotic syndrome, infection, poorly controlled diabetes;
- Patients with active HIV（human immunodeficiency virus）, HBV（hepatitis B virus）, or HCV（hepatitis C virus） infection;
- Patients had undergone surgery (<28 days) or did not heal completely, or had other unhealed wounds before the study;
- Patients known to be allergic to bevacizumab or any of the components of the drug;
- Pregnant or lactating female patients, or unwilling to take contraceptive measures of reproductive age patients (including men);
- There is a serious psychological or mental abnormality, or lack of compliance;
- The investigator determines other circumstances that may affect the conduct of clinical studies and the determination of findings;
- Participants with an active, known or suspected autoimmune disease;
- Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first treatment;
- Participants with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug related pulmonary toxicity.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jian Fang
Beijing, Beijing Municipality, 100142
Jian Fang, +86-010-88196469, bcht2_mj@163.com
Jie Zhang, +86-010-88196478, zhangjie@bjmu.edu.cn
About this study
Official title: A Prospective of Efficacy and Safety of Use of Platinum Based Doublet Chemotherapy Plus Antiangiogenesis and Immune Checkpoint Inhibitors in Patients With Advanced Non-squamous Non-small Cell Lung Cancer
The purpose of this study is to explore the efficacy and safety of Use of Platinum Based Doublet Chemotherapy Plus Antiangiogenesis and Immune Checkpoint Inhibitors in Patients With Advanced Non-squamous Non-small Cell Lung Cancer
- Being tested
- Antiangiogenesis Agents, Immune checkpoint inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiangiogenesis AgentsDrug
antiangiogenesis agents plus chemotherapy as first line treatment
Immune checkpoint inhibitorDrug
immune checkpoint inhibitor plus chemotherapy as first line treatment
| Study group | Role | What they receive |
|---|---|---|
| Group A | antiangiogenesis 7.5mg/Kg q3w+pemetrexed 500mg/m2 q3w+ platinum 75mg/m2 q3w Receives: Drug: Antiangiogenesis Agents | |
| Group B | immune checkpoint inhibitors 200mg q3w+pemetrexed 500mg/m2 q3w+platinum 75mg/m2 q3w Receives: Drug: Immune checkpoint inhibitor | |
| Group C | antiangiogenesis 7.5mg/Kg q3w+immune checkpoint inhibitors 200mg q3w+pemetrexed 500mg/m2 q3w+platinum 75mg/m2 q3w Receives: Drug: Antiangiogenesis Agents; Drug: Immune checkpoint inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
ORR of treatment
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start3 Mar 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Jun 2022 (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.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Fang, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137588
- Sponsor's protocol ID
- 20191023
- Status last verified
- Feb 2021
- First submitted
- 22 Oct 2019
- Last updated
- 24 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective of Efficacy and Safety of Use of Platinum Based Doublet Chemotherapy Plus Antiangiogenesis and Immune Checkpoint Inhibitors in Patients With Advanced Non-squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04137588
- Acronym / sponsor ID
- 20191023
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 3 Mar 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 24 Oct 2019 (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.
The purpose of this study is to explore the efficacy and safety of Use of Platinum Based Doublet Chemotherapy Plus Antiangiogenesis and Immune Checkpoint Inhibitors in Patients With Advanced Non-squamous Non-small Cell Lung Cancer
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Drug: Antiangiogenesis Agentsantiangiogenesis 7.5mg/Kg q3w+pemetrexed 500mg/m2 q3w+ platinum 75mg/m2 q3w |
| Group B | – | Drug: Immune checkpoint inhibitorimmune checkpoint inhibitors 200mg q3w+pemetrexed 500mg/m2 q3w+platinum 75mg/m2 q3w |
| Group C | – | Drug: Antiangiogenesis Agents, Drug: Immune checkpoint inhibitorantiangiogenesis 7.5mg/Kg q3w+immune checkpoint inhibitors 200mg q3w+pemetrexed 500mg/m2 q3w+platinum 75mg/m2 q3w |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Males and females, 18-75 years of age, non squamous non-small cell lung cancer, wild type genotype
Key inclusion criteria (6 listed)
- Voluntarily sign informed consent;
- Non-squamous non-small cell lung cancer, newly diagnosed or previously not treated with systemic chemotherapy and / or epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors treatment;
- Aged 18-75 years;
- Eastern Cooperative Oncology Group (ECOG) score ≤ 2;
- Survival is expected to exceed 12 weeks ;
Key exclusion criteria (29 listed)
- Squamous cell carcinoma (including adenosquamous carcinoma) and small cell lung cancer (including small cell carcinoma and non-small cell mixed lung cancer);
- In the past 2 weeks, there have been systematic anti-tumor treatment including chemotherapy (including thoracic chemotherapy), radiotherapy (excluding radiotherapy of metastatic lesions outside the thoracic radiation field), targeted therapy, immunotherapy and biotherapy;
- The subject had received anti-vascular endothelial growth factor (VEGF) small molecule tyrosine kinase inhibitors or monoclonal antibodies in the past 4 weeks;
- Laboratory results:
- Heart disease with significant clinical symptoms, such as: congestive heart failure, coronary heart disease with symptom, arrhythmia hardly be controlled by drugs, myocardial infarction in 6 months, or heart failure;
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 |
|---|---|---|
| Antiangiogenesis Agentsantiangiogenesis agents plus chemotherapy as first line treatment | Drug | Group A, Group C |
| Immune checkpoint inhibitorimmune checkpoint inhibitor plus chemotherapy as first line treatment | Drug | Group B, Group C |
Primary outcome
objective response rate
Time frame: one year
ORR of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
Related trials for Advanced Non-squamous Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Not yet recruitingPhase 2
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148(ABBV-1480) as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology
Active, not recruitingPhase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
Non-small Cell Lung Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Non-squamous Non-small Cell Lung Cancer, run by Peking University Cancer Hospital & Institute at 1 site 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 6 inclusion and 29 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 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 Jian Fang, doctor (+86-010-88196469, bcht2_mj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: one year). 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 24 Feb 2021.