Ib-IIIb NSCLCPhase 2NCT04897386
Monitoring the Efficacy of Duvalizumab Combined With Neoadjuvant Chemotherapy for Ib-IIIb NSCLC by Sequencing of Immune Receptor Repertoire: a Prospective, One Arm Clinical Study
A Phase 2 study testing Duvalizumab in people with Ib-IIIb NSCLC, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
To observe and evaluate the efficacy and safety of Duvalizumab Combined With Neoadjuvant Chemotherapy for Ib-IIIb NSCLC and the relevance with Immune Receptor Repertoire Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ib-IIIb NSCLC
- What is being tested?
- Duvalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 1 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥ 18 years old;
- NSCLC confirmed by histopathology;
- According to the doctor's advice, according to the routine diagnosis and treatment process, lung cancer patients who need radical resection and neoadjuvant therapy before operation;
- No previous treatment for esophageal cancer, including surgery, chemotherapy, radiotherapy, targeted therapy, hormone or immunotherapy;
- ECoG score was 0 or 1;
- There was no operative contraindication in preoperative organ function examination;
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- At least 6 months of expected survival
- The laboratory examination met the following standards:
- Bone marrow function: hemoglobin (HB) ≥ 90g / L; White blood cell count (WBC) ≥ the lower limit of normal value; Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L； Platelet count ≥ 90 × 10^9/L；
- Renal function: Cr ≤ unl (upper limit of normal value) × 5, CCR ≥ 55ml / min;
- Liver function: total bilirubin ≤ ULN × 1.5； ALT and AST ≤ ULN × 2.5 (patients with liver metastasis can be relaxed to ≤ 5 * ULN);
- Coagulation function: international normalized ratio of prothrombin time ≤ ULN × 5, and partial thromboplastin time was within the normal range;
- The subjects agreed and voluntarily signed the informed consent
Who cannot join
- Allergic to the study drug;
- History of hemorrhagic disease or with hemorrhagic disease
- Liver and kidney dysfunction;
- Patients with uncontrolled diseases (including but not limited to: active infection, symptomatic congestive heart failure; Myocardial infarction occurred within 3 months; Unstable angina, arrhythmia, etc.);
- Women of childbearing age are unwilling to use contraception;
- Lactating women;
- For any other reason, the researchers consider it inappropriate to participate in the trial.
Trial locations and contacts
No sites are listed yet.
About this study
To observe and evaluate the efficacy and safety of Duvalizumab Combined With Neoadjuvant Chemotherapy for Ib-IIIb NSCLC and the relevance with Immune Receptor Repertoire
- Conditions
- Ib-IIIb NSCLC
- Being tested
- Duvalizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuvalizumabDrug
Also called Pemetrexed, platinum
Pemetrexed 850 mg, IV, Day1; Platinum 50mg / m2, IV, day1, once every 3 weeks, duvalizumab treatment, 1500mg, day1, a total of 4 cycles, once every 3 weeks. 4 cycles in total
| Study group | Role | What they receive |
|---|---|---|
| Duvalizumab Combined With Neoadjuvant Chemotherapy | Experimental | Not described Receives: Drug: Duvalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate
Measured: at 64th week
DFS
disease free survival
Measured: at 64th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ib-IIIb NSCLCStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaorong Dong, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897386
- Sponsor's protocol ID
- duvalizumab
- Status last verified
- May 2021
- First submitted
- 20 May 2021
- Last updated
- 21 May 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 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Efficacy of Duvalizumab Combined With Neoadjuvant Chemotherapy for Ib-IIIb NSCLC by Sequencing of Immune Receptor Repertoire: a Prospective, One Arm Clinical Study
- ClinicalTrials.gov ID
- NCT04897386
- Acronym / sponsor ID
- duvalizumab
- Conditions
- Ib-IIIb NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 21 May 2021 (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 observe and evaluate the efficacy and safety of Duvalizumab Combined With Neoadjuvant Chemotherapy for Ib-IIIb NSCLC and the relevance with Immune Receptor Repertoire
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duvalizumab Combined With Neoadjuvant Chemotherapy | Experimental | Drug: Duvalizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age: ≥ 18 years old;
- NSCLC confirmed by histopathology;
- According to the doctor's advice, according to the routine diagnosis and treatment process, lung cancer patients who need radical resection and neoadjuvant therapy before operation;
- No previous treatment for esophageal cancer, including surgery, chemotherapy, radiotherapy, targeted therapy, hormone or immunotherapy;
- ECoG score was 0 or 1;
Key exclusion criteria (7 listed)
- Allergic to the study drug;
- History of hemorrhagic disease or with hemorrhagic disease
- Liver and kidney dysfunction;
- Patients with uncontrolled diseases (including but not limited to: active infection, symptomatic congestive heart failure; Myocardial infarction occurred within 3 months; Unstable angina, arrhythmia, etc.);
- Women of childbearing age are unwilling to use contraception;
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 |
|---|---|---|
| DuvalizumabAlso: Pemetrexed, platinumPemetrexed 850 mg, IV, Day1; Platinum 50mg / m2, IV, day1, once every 3 weeks, duvalizumab treatment, 1500mg, day1, a total of 4 cycles, once every 3 weeks. 4 cycles in total | Drug | Duvalizumab Combined With Neoadjuvant Chemotherapy |
Primary outcome
ORR
Time frame: at 64th week
Objective response rate
DFS
Time frame: at 64th week
disease free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Duvalizumab in people with Ib-IIIb NSCLC, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 13 inclusion and 7 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 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Xiaorong Dong, PhD (027-85872859, xiaorongdong@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: at 64th week). 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 21 May 2021.