EfficacyPhase 1/2NCT05325684
PD-L1 Inhibitor Rechallenge After PD-1 Immunotherapy for Patients With Solid Tumor Beyond Lung Cancer
A Phase 1/2 study testing PD-L1 inhibitor in people with Efficacy and Safety, run by The Affiliated Hospital of Qingdao University.
Trial summary
Anti-PD-L1 immune checkpoint inhibitor, is approved for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy, or as first-line treatment of patients with ES-SCLC in combination with etoposide and either… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- PD-L1 inhibitor
- 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
- Apr 2022to Dec 2023
- Phase
- Phase 1/2
- 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
- Signed Informed Consent Form
- Ability to comply with protocol
- Aged ≥ 18 years
- Histologically documented advanced solid tumor beyond lung cancer
- Disease progression during or following at least one line treatment containing PD-1 immunotherapy.
- Measurable disease, as defined by RECIST v1.1
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- ECOG performance status of 0 or 1
- Life expectancy ≥ 12 weeks
- Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment:
- ANC ≥ 1.5 × 109/L (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility) WBC counts > 2.5 × 109/L and < 15 × 109/L Lymphocyte count ≥ 0.5 × 109/L Serum albumin ≥ 2.5 g/dL Platelet count ≥ 100 × 109/L (without transfusion within 2 weeks of laboratory test used to determine eligibility) Hemoglobin ≥ 9.0 g/dL Patients may be transfused or receive erythropoietic treatment to meet this criterion.
- Liver function tests meeting one of the following criteria:
- AST or ALT ≤ 2.5 × upper limit of normal (ULN), with alkaline phosphatase
- ≤ 2.5 × ULN or AST and ALT ≤ 1.5 × ULN in conjunction with alkaline phosphatase > 2.5 × ULN Serum bilirubin ≤ 1.5 × ULN Patients with known Gilbert's disease who have serum bilirubin level ≤ 3 × ULN may be enrolled. INR and aPTT ≤ 1.5 × ULN This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose for at least 1 week prior to randomization. Creatinine clearance ≥ 30 mL/min Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration, or Modification of Diet in Renal Disease formulas may be used for creatinine clearance calculation. Note that 24-hour urine collection is not required but is allowed.
Who cannot join
- Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
- Leptomeningeal disease
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Uncontrolled hypertension
- Autoimmune disease
- Had undergone a serious anaphylactic reaction in previous immunotherapy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of PD-L1 Inhibitor in Patients With Advanced Solid Tumors Beyond Lung Cancer: a PhaseⅠB Clinical Study
Anti-PD-L1 immune checkpoint inhibitor, is approved for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy, or as first-line treatment of patients with ES-SCLC in combination with etoposide and either carboplatin or cisplatin in China. The clinical data regarding the PD-L1 inhibitor in other solid tumors are limited.Investigators would observe and analyze the effectiveness and safety of PD-L1 inhibitor for patients with advanced - solid tumors beyond lung cancer after muti-line therapy to explore the synergistic effect of PD-L1 inhibitor rechallenge after PD-1immunotherapy.
- Being tested
- PD-L1 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-L1 inhibitorDrug
Enrolled patients received durvalumab/ Atezolizumab plus chemotherapy or target therapy treatment (durvalumab,1000mg，iv, d1, 21day as a cycle; Atezolizumab,1200mg iv, d1, 21day as a cycle.)
| Study group | Role | What they receive |
|---|---|---|
| PD-L1 rechallenge | Experimental | Not described Receives: Drug: PD-L1 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
DCR
Disease Control Rate
Measured: At the end of Cycle 3 (each cycle is 21 days)".
PFS
progression-free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (2)
OS
overall survival
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
AE
adverse event caused by the treatment
Measured: hrough 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 posted13 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EfficacyStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhangxiaochun, The Affiliated Hospital of Qingdao University
- Investigators
- Xiaochun Zhang, Prof, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325684
- Sponsor's protocol ID
- PDL1-BEY-LUNG
- Status last verified
- Mar 2022
- First submitted
- 31 Mar 2022
- Last updated
- 13 Apr 2022
- 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 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of PD-L1 Inhibitor in Patients With Advanced Solid Tumors Beyond Lung Cancer: a PhaseⅠB Clinical Study
- ClinicalTrials.gov ID
- NCT05325684
- Acronym / sponsor ID
- PDL1-BEY-LUNG
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Apr 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.
Anti-PD-L1 immune checkpoint inhibitor, is approved for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy, or as first-line treatment of patients with ES-SCLC in combination with etoposide and either carboplatin or cisplatin in China. The clinical data regarding the PD-L1 inhibitor in other solid tumors are limited.Investigators would observe and analyze the effectiveness and safety of PD-L1 inhibitor for patients with advanced - solid tumors beyond lung cancer after muti-line therapy to explore the synergistic effect of PD-L1 inhibitor rechallenge after PD-1immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-L1 rechallenge | Experimental | Drug: PD-L1 inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed Informed Consent Form
- Ability to comply with protocol
- Aged ≥ 18 years
- Histologically documented advanced solid tumor beyond lung cancer
- Disease progression during or following at least one line treatment containing PD-1 immunotherapy.
Key exclusion criteria (6 listed)
- Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
- Leptomeningeal disease
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Uncontrolled hypertension
- Autoimmune disease
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 |
|---|---|---|
| PD-L1 inhibitorEnrolled patients received durvalumab/ Atezolizumab plus chemotherapy or target therapy treatment (durvalumab,1000mg，iv, d1, 21day as a cycle; Atezolizumab,1200mg iv, d1, 21day as a cycle.) | Drug | PD-L1 rechallenge |
Primary outcome
DCR
Time frame: At the end of Cycle 3 (each cycle is 21 days)".
Disease Control Rate
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
progression-free survival
2 secondary outcomes
OS
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
AE
Time frame: hrough study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
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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.
Xiaochun Zhang, Prof principal investigator
The Affiliated Hospital of Qingdao University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PD-L1 inhibitor in people with Efficacy and Safety, run by The Affiliated Hospital of Qingdao University.
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 6 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 13 Apr 2022. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Xiaochun Zhang, Prof (086053282913271, zxcgcp@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DCR (time frame: At the end of Cycle 3 (each cycle is 21 days)".). 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 13 Apr 2022.