NSCLC PatientsNCT04427475
Prediction of Immunotherapeutic Effect of Advanced Non-small Cell Lung Cancer
A study testing pabolizumab and nafulizumab in people with NSCLC Patients, run by Fudan University at 1 site in China.
Trial summary
To detect the difference of PD-L1 and miRNA expression profiles of exosomes in NSCLC patients before and after immunotherapy, and to explore the potential of plasma exosomes PD-L1 and miRNAs as biomarkers to predict the therapeutic effect of NSCLC on anti-PD-1 / PD-L1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC Patients
- What is being tested?
- pabolizumab and nafulizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2020to 31 Dec 2022
- Phase
- Interventional
- 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
- Sign informed consent.
- The age is greater than or equal to 18 years old.
- There is at least one measurable focus according to the RECIST 1.1 standard
- EGFR / ALK detection is not needed in patients with metastatic (stage IV) EGFR / ALK wild-type NSCLC confirmed by histology or cytology and in patients with squamous cell carcinoma.
- Cohort 1: patients receiving anti-PD-1 (pabolizumab) treatment combined with chemotherapy as the first-line treatment Cohort 2: patients who received the second-line treatment of anti-PD-1 single drug (nafulizumab) for the progress of disease after chemotherapy with platinum containing dual drugs
- ECoG score is 0, 1 or 2.
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- No serious blood system, heart, lung, liver and kidney dysfunction and immune deficiency.
- Hemoglobin (HB) ≥ 9g / dl; leukocyte (WBC) ≥ 3 * 109 / L; neutrophil (ANC) ≥ 1.5 * 109 / L; platelet (PLT) ≥ 75 * 109 / L.
- Men or women of childbearing age are willing to take contraceptive measures in the experiment.
- Estimated survival time ≥ 3 months.
Who cannot join
- Histologically, small cell and non-small cell mixed lung cancer.
- Pregnant or nursing women.
- Any unresponsive > CTCAE Level 2 toxicity caused by past anti-tumor treatment
- Serum creatinine clearance < 30 ml / min (calculated by Cockcroft Gault formula)
- Liver dysfunction, defined as:
- Serum (total) bilirubin > 1.5 × upper limit of normal value (ULN)
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- Serum AST / SGOT or ALT / SGPT > 2.5 × ULN (liver metastasis > 5 × ULN)
- Alkaline phosphatase level > 2.5 × ULN (liver metastasis > 5 × ULN, or bone) at baseline Transfer patients > 10 × ULN)
- Have a history of uncontrollable or symptomatic angina, arrhythmia or congestive heart failure.
- Symptomatic brain metastasis or meningeal metastasis.
- In the past 5 years, she has had or is suffering from other histological types of malignant tumors, except for cervical carcinoma in situ and fully treated skin basal cell carcinoma or squamous cell carcinoma.
- Have active, or have had and may recur autoimmune diseases. However, subjects with type I diabetes, hypothyroidism requiring hormone replacement therapy only, skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia), or no relapse without external triggers are expected.
- Diagnosis of immunodeficiency or systemic hormone therapy (e.g., hormone therapy equivalent to > 10 mg prednisone per day) or any other form of immunosuppressive therapy within 7 days before the first administration.
- Patients with known history of human immunodeficiency virus (HIV) infection and / or acquired immunodeficiency syndrome. Subjects with active hepatitis B or active hepatitis C
- Grade 2 pneumonia caused by radiotherapy and chemotherapy (grade 2 pneumonia without systemic hormone treatment recovers to grade 1 or below within 14 days, if the researcher judges that there is no risk of recurrence, it can be included in the group for screening).
- Have interstitial lung disease and the disease has symptoms.
- During the study period, radiotherapy is planned for the target focus.
- Plan to use other anti-tumor therapy during the study period.
- Patients with serious or uncontrolled systemic diseases who are not suitable for the study or may affect the compliance of the other party's case. Subjects' complications or other conditions may affect compliance with the protocol or may not be suitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, 200032
wang jia lei, DOCTOR, 18017312369, haitunqiao@hotmail.com
About this study
Official title: Study on the Prediction of Immunotherapeutic Effect of Advanced Non-small Cell Lung Cancer by Detection of Plasma Exosomes
To detect the difference of PD-L1 and miRNA expression profiles of exosomes in NSCLC patients before and after immunotherapy, and to explore the potential of plasma exosomes PD-L1 and miRNAs as biomarkers to predict the therapeutic effect of NSCLC on anti-PD-1 / PD-L1.
- Conditions
- NSCLC Patients
- Being tested
- pabolizumab, nafulizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pabolizumabDrug
100 patients with stage IV EGFR / ALK wild-type NSCLC (squamous cell carcinoma patients do not need to be detected) who received anti-PD-1 (pabolizumab) treatment combined with chemotherapy as the first-line treatment were enrolled in the center. Baseline plasma samples were collected before the treatment, and the efficacy was evaluated once every two treatment cycles. At the same time, plasma samples were collected at key nodes until the patient's progress.
nafulizumabDrug
nafulizumab
| Study group | Role | What they receive |
|---|---|---|
| pabolizumab | Other | Baseline plasma samples were collected before the treatment, and the efficacy was evaluated once every two treatment cycles. Receives: Drug: pabolizumab |
| nafulizumab | Other | Baseline plasma samples were collected before the treatment, and the efficacy was evaluated once every two treatment cycles. Receives: Drug: nafulizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PD-L1 expression profiles of exosomes
detect the difference of PD-L1 expression profiles of exosomes in NSCLC patients before and after immunotherapy
Measured: through study completion, an average of 1 year
miRNA expression profiles of exosomes
detect the difference of miRNA expression profiles of exosomes in NSCLC patients before and after immunotherapy
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start8 Jun 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC PatientsStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jialei Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427475
- Sponsor's protocol ID
- MIRNA-SEP-01
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2020
- Last updated
- 11 Jun 2020
- 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 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Prediction of Immunotherapeutic Effect of Advanced Non-small Cell Lung Cancer by Detection of Plasma Exosomes
- ClinicalTrials.gov ID
- NCT04427475
- Acronym / sponsor ID
- MIRNA-SEP-01
- Conditions
- NSCLC Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 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.
To detect the difference of PD-L1 and miRNA expression profiles of exosomes in NSCLC patients before and after immunotherapy, and to explore the potential of plasma exosomes PD-L1 and miRNAs as biomarkers to predict the therapeutic effect of NSCLC on anti-PD-1 / PD-L1.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pabolizumab | Other | Drug: pabolizumabBaseline plasma samples were collected before the treatment, and the efficacy was evaluated once every two treatment cycles. |
| nafulizumab | Other | Drug: nafulizumabBaseline plasma samples were collected before the treatment, and the efficacy was evaluated once every two treatment cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Sign informed consent.
- The age is greater than or equal to 18 years old.
- There is at least one measurable focus according to the RECIST 1.1 standard
- EGFR / ALK detection is not needed in patients with metastatic (stage IV) EGFR / ALK wild-type NSCLC confirmed by histology or cytology and in patients with squamous cell carcinoma.
- Cohort 1: patients receiving anti-PD-1 (pabolizumab) treatment combined with chemotherapy as the first-line treatment Cohort 2: patients who received the second-line treatment of anti-PD-1 single drug (nafulizumab) for the progress of disease after chemotherapy with platinum containing dual drugs
Key exclusion criteria (19 listed)
- Histologically, small cell and non-small cell mixed lung cancer.
- Pregnant or nursing women.
- Any unresponsive > CTCAE Level 2 toxicity caused by past anti-tumor treatment
- Serum creatinine clearance < 30 ml / min (calculated by Cockcroft Gault formula)
- Liver dysfunction, defined as:
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 |
|---|---|---|
| pabolizumab100 patients with stage IV EGFR / ALK wild-type NSCLC (squamous cell carcinoma patients do not need to be detected) who received anti-PD-1 (pabolizumab) treatment combined with chemotherapy as the first-line treatment were enrolled in the center. Baseline plasma samples were collected before the treatment, and the efficacy was evaluated once every two treatment cycles. At the same time, plasma samples were collected at key nodes until the patient's progress. | Drug | pabolizumab |
| nafulizumabnafulizumab | Drug | nafulizumab |
Primary outcome
PD-L1 expression profiles of exosomes
Time frame: through study completion, an average of 1 year
detect the difference of PD-L1 expression profiles of exosomes in NSCLC patients before and after immunotherapy
miRNA expression profiles of exosomes
Time frame: through study completion, an average of 1 year
detect the difference of miRNA expression profiles of exosomes in NSCLC patients before and after immunotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pabolizumab and nafulizumab in people with NSCLC Patients, run by Fudan University 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 10 inclusion and 19 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 11 Jun 2020. 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 wang jia lei, doctor (18017312369, haitunqiao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PD-L1 expression profiles of exosomes (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2020.