Non-small Cell Lung CancerPhase 2NCT05738317
Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel in Non-squamous NSCLC After First-line Treatment
A Phase 2 study testing Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel in people with Non-small Cell Lung Cancer, run by Xiaorong Dong at 1 site in China.
Trial summary
A prospective, single-arm, phase II trial of Adebrelimab combined with bevacizumab and albumin paclitaxel in advanced non-squamous non-small cell lung cancer after first-line immunotherapy progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 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
- voluntarily enrolled in this study and signed the Informed Consent Form (ICF).
- age ≥ 18 years and both sexes
- patients with metastatic or recurrent stage IV non-squamous NSCLC (AJCC 8th edition TNM stage) proven by histopathological or cytopathological diagnosis, mainly including adenocarcinoma, large cell lung cancer, adenocarcinoma with squamous differentiation or adenosquamous carcinoma with predominantly adenocarcinoma component may also be enrolled if eligible by study assessment.
- objective imaging progression (RECIST v1.1 assessment) after subjects have received a first-line regimen containing immune checkpoint inhibitor therapy.
- the best outcome of first-line immune checkpoint inhibitor-containing therapy is SD, PR, CR, and PFS of ≥ 3 months on first-line therapy.
- imaging evaluation (CT or MRI) with at least one measurable target lesion (according to RECIST v1.1 criteria) within 4 weeks prior to enrollment.
Show all 14Show fewer
- an ECOG PS score of 0-1 within 4 weeks prior to enrollment.
- an expected survival of ≥ 12 weeks.
- function of vital organs in accordance with the following requirements. (1) blood routine: white blood cell count (WBC) ≥ 3.0×109/L; absolute neutrophil count (ANC) ≥ 1.5×109/L; platelets (PLT) ≥ 100×109/L; hemoglobin level (HGB) ≥ 9.0 g/dL (no corresponding supportive treatment such as blood transfusion and leukocyte boosting within 7 days).
- Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN in patients without liver metastases, ALT and AST ≤ 5 times ULN in patients with liver metastases; serum total bilirubin (TBIL) ≤ 1.5 times ULN (except total bilirubin < 3.0 mg/dL in Gilbert syndrome); albumin (ALB) ≥ 30 g/L, alkaline phosphatase (ALP) ≤ 2.5×ULN, and in patients with bone metastases, ALP ≤ 5×ULN.
- renal function: serum creatinine ≤ 1.5 times ULN or creatinine clearance (CrCl) ≥ 50 mL/min (using Cockcroft/Gault formula); urine protein (UPRO) < (++), or 24-hour urine protein amount < 1.0 g.
- Coagulation function: international normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; if the patient is receiving anticoagulation therapy, as long as PT or APTT is within the therapeutic range of the intended use of anticoagulants, referring to the relevant drug instructions.
- Thyrotropin (TSH) ≤ upper limit of normal (ULN); if abnormal, T3 and T4 levels should be examined; normal T3 and T4 levels are eligible for enrollment.
- 10. Non-surgical sterilization or female patients of childbearing age must have a negative serum pregnancy test within 7 days prior to the first dose and must be non-lactating. Female patients of childbearing age or male patients whose partners are women of childbearing age must agree to use highly effective methods of contraception during the study period and for 6 months after the last administration of the study drug.
Who cannot join
- patients with other pathological tissue types of non-small cell lung cancer (including squamous cell carcinoma, mixed non-small cell and small cell lung cancer, and predominantly squamous adenosquamous carcinoma of the lung)
- patients with known EGFR-sensitive mutations (19Exon del/21Exon L858R), positive ALK/ROS1 fusion, BRAFV600E mutation, MET gene exon 14 jump mutation, positive RET gene fusion, and other patients with approved targets for targeted agents.
- patients with imaging showing signs of tumor invasion into the great vessels, where the tumor has completely approached, encircled, or invaded the lumen of a great vessel (e.g., pulmonary artery or superior vena cava)
- patients with hypertension whose blood pressure is not satisfactorily controlled by antihypertensive medication (sitting systolic blood pressure > 150 mmHg, or diastolic blood pressure > 100 mmHg), previous hypertensive crisis or hypertensive encephalopathy
- those with a known hereditary bleeding tendency or coagulation disorders; those who have received full-dose anticoagulant or thrombolytic therapy within 10 days prior to enrollment, or those who have taken non-steroidal anti-inflammatory drugs with platelet inhibitory effects within 10 days prior to enrollment (except for prophylactic use of low-dose aspirin (≤325 mg/day)).
- had a hemoptysis of 2nd degree or greater with a single hemoptysis of ≥1/2 teaspoon (2.5 ml) within 3 months prior to enrollment
Show all 9Show fewer
- thrombosis in the 6 months prior to enrollment and an arterial/venous thrombotic event within 1 year prior to screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism.
- those with severe vascular lesions (including aneurysms or arterial thrombosis requiring surgical treatment) within 6 months prior to enrollment
- late first-line treatment with anti-angiogenic agents, including but not limited to bevacizumab, apatinib, anlotinib, ramucirumab, lenvatinib, etc.; treatment with paclitaxel, including paclitaxel, albumin paclitaxel, paclitaxel liposome, docetaxel (polyene paclitaxel), etc;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union hospital
Wuhan, Hubei, 430000
Xiaorong Dong, Dr.
About this study
Official title: A Prospective, Single-arm, Phase II Trial of Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel in Advanced Non-squamous Non-small Cell Lung Cancer After First-line Immunotherapy Progression
A prospective, single-arm, phase II trial of Adebrelimab combined with bevacizumab and albumin paclitaxel in advanced non-squamous non-small cell lung cancer after first-line immunotherapy progression.
Read the detailed description
The study consisted of a screening period (no more than 4 weeks after patients signed informed consent until enrollment, with imaging assessments allowed to be archived within 4 weeks prior to enrollment), a treatment period (treatment termination defined as discontinuation of treatment for any reason, or withdrawal from the study for any reason), a safety follow-up period, and a survival follow-up period.
Screening period:
Patients were required to undergo a screening evaluation to determine their eligibility for the study within 4 weeks prior to enrollment.
Patients eligible for the study receive adebrelimab, 20 mg/kg, Intravenous infusion, Q3W + bevacizumab, 7.5 mg/kg, Intravenous infusion, Q3W + albumin paclitaxel 100 mg/m2, D1, 8, 15, Intravenous infusion, Q3W. albumin paclitaxel treatment for 4 cycles, adebrelimab, bevacizumab use to PD, intolerable toxicity, patient withdrawal of informed consent, investigator decision to discontinue study treatment.
Treatment period:
Patients eligible for study enrollment were given medication sequentially on day 1 of each cycle, with a dosing window of ±5 days, and patients were required to complete various examinations including vital signs, height and weight, physical examination, laboratory tests, and physical status scores to assess tolerance for continued treatment. The specific examinations and requirements for each visit are shown in the study flow chart.
End of treatment:
End of treatment is defined as confirmation of disease progression or withdrawal from the study and requires an end-of-treatment visit ±5 days from the time of the decision to discontinue treatment and/or withdraw from the study.
Safety follow-up. Safety follow-up visits will be conducted within 30±7, 60±7 days, and 90±7 days after the last dose.
Survival follow-up. Survival follow-up will be conducted every 3 months after safety follow-up and telephone follow-up is acceptable.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab Combined With Bevacizumab and Albumin PaclitaxelDrug
Adebrelimab is recommended to be administered with an infusion pump. The infusion pipeline is equipped with a 0.22-micron online filter membrane. Intravenous injection or bolus injection is not allowed. At the end of infusion, flush the infusion tube with sufficient 5% glucose or physiological saline, and do not share the same infusion tube with other drugs. In each treatment cycle, Adebrelimab should be given intravenously first.
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel | Experimental | Adebrelimab: 20 mg/kg Adebrelimab is given on day 1 of each cycle, with 1 dosing cycle every 3 weeks. The dosing time window may be ±5 days, but within 72 hours before each dose, subjects must complete an examination including all clinically necessary tests to assess tolerability of continued dosing, in addition to imaging. Subjects are also advised to remain in the hospital for observation 72 hours after the first dose.
Bevacizumab: 7.5 mg/kg Bevacizumab administered intravenously on day 1 of each cycle, with 1 dosing cycle every 3 weeks.
Albumin Paclitaxel: 100 mg/m2 Albumin Paclitaxel is given on days 1, 8, and 15 of each cycle by intravenous infusion for 1 dosing cycle every 3 weeks. Receives: Drug: Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month PFS rate
6-Month PFS Rates for Adebrelimab Combined with Bevacizumab and Albumin Paclitaxel in Patients with Advanced NSCLC Progressed by First-Line Immunotherapy Evaluated by Investigators
Measured: 6 months
Secondary outcomes (3)
Progression-free survival (PFS)
PFS is defined as the time elapsed between the start of treatment and the first sign of disease progression or death from any cause.
Measured: up to 12 months
Over survival (OS)
OS is defined as the time elapsed between the initiation of treatment and mortality from any cause.
Measured: up to 12 months
Disease control rate (DCR)
Number of cases with completed/partial response and stable disease after treatment as a percentage of evaluable cases.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Dec 2022
- Primary completion1 Jun 2023 (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 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with advanced non-squamous non-small cell lung cancer after first-line immunotherapy progression
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaorong Dong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaorong Dong, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Xiaorong Dong, Dr., Study chair, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738317
- Sponsor's protocol ID
- MA-NSCLC-II-026
- Status last verified
- Feb 2023
- First submitted
- 12 Feb 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Phase II Trial of Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel in Advanced Non-squamous Non-small Cell Lung Cancer After First-line Immunotherapy Progression
- ClinicalTrials.gov ID
- NCT05738317
- Acronym / sponsor ID
- MA-NSCLC-II-026
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Xiaorong DongUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 22 Feb 2023 (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.
A prospective, single-arm, phase II trial of Adebrelimab combined with bevacizumab and albumin paclitaxel in advanced non-squamous non-small cell lung cancer after first-line immunotherapy progression.
Detailed description
The study consisted of a screening period (no more than 4 weeks after patients signed informed consent until enrollment, with imaging assessments allowed to be archived within 4 weeks prior to enrollment), a treatment period (treatment termination defined as discontinuation of treatment for any reason, or withdrawal from the study for any reason), a safety follow-up period, and a survival follow-up period.
Screening period:
Patients were required to undergo a screening evaluation to determine their eligibility for the study within 4 weeks prior to enrollment.
Patients eligible for the study receive adebrelimab, 20 mg/kg, Intravenous infusion, Q3W + bevacizumab, 7.5 mg/kg, Intravenous infusion, Q3W + albumin paclitaxel 100 mg/m2, D1, 8, 15, Intravenous infusion, Q3W. albumin paclitaxel treatment for 4 cycles, adebrelimab, bevacizumab use to PD, intolerable toxicity, patient withdrawal of informed consent, investigator decision to discontinue study treatment.
Treatment period:
Patients eligible for study enrollment were given medication sequentially on day 1 of each cycle, with a dosing window of ±5 days, and patients were required to complete various examinations including vital signs, height and weight, physical examination, laboratory tests, and physical status scores to assess tolerance for continued treatment. The specific examinations and requirements for each visit are shown in the study flow chart.
End of treatment:
End of treatment is defined as confirmation of disease progression or withdrawal from the study and requires an end-of-treatment visit ±5 days from the time of the decision to discontinue treatment and/or withdraw from the study.
Safety follow-up. Safety follow-up visits will be conducted within 30±7, 60±7 days, and 90±7 days after the last dose.
Survival follow-up. Survival follow-up will be conducted every 3 months after safety follow-up and telephone follow-up is acceptable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with advanced non-squamous non-small cell lung cancer after first-line immunotherapy progression
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel | Experimental | Drug: Adebrelimab Combined With Bevacizumab and Albumin PaclitaxelAdebrelimab: 20 mg/kg Adebrelimab is given on day 1 of each cycle, with 1 dosing cycle every 3 weeks. The dosing time window may be ±5 days, but within 72 hours before each dose, subjects must complete an examination including all clinically necessary tests to assess tolerability of continued dosing, in addition to imaging. Subjects are also advised to remain in the hospital for observation 72 hours after the first dose. Bevacizumab: 7.5 mg/kg Bevacizumab administered intravenously on day 1 of each cycle, with 1 dosing cycle every 3 weeks. Albumin Paclitaxel: 100 mg/m2 Albumin Paclitaxel is given on days 1, 8, and 15 of each cycle by intravenous infusion for 1 dosing cycle every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- voluntarily enrolled in this study and signed the Informed Consent Form (ICF).
- age ≥ 18 years and both sexes
- patients with metastatic or recurrent stage IV non-squamous NSCLC (AJCC 8th edition TNM stage) proven by histopathological or cytopathological diagnosis, mainly including adenocarcinoma, large cell lung cancer, adenocarcinoma with squamous differentiation or adenosquamous carcinoma with predominantly adenocarcinoma component may also be enrolled if eligible by study assessment.
- objective imaging progression (RECIST v1.1 assessment) after subjects have received a first-line regimen containing immune checkpoint inhibitor therapy.
- the best outcome of first-line immune checkpoint inhibitor-containing therapy is SD, PR, CR, and PFS of ≥ 3 months on first-line therapy.
Key exclusion criteria (9 listed)
- patients with other pathological tissue types of non-small cell lung cancer (including squamous cell carcinoma, mixed non-small cell and small cell lung cancer, and predominantly squamous adenosquamous carcinoma of the lung)
- patients with known EGFR-sensitive mutations (19Exon del/21Exon L858R), positive ALK/ROS1 fusion, BRAFV600E mutation, MET gene exon 14 jump mutation, positive RET gene fusion, and other patients with approved targets for targeted agents.
- patients with imaging showing signs of tumor invasion into the great vessels, where the tumor has completely approached, encircled, or invaded the lumen of a great vessel (e.g., pulmonary artery or superior vena cava)
- patients with hypertension whose blood pressure is not satisfactorily controlled by antihypertensive medication (sitting systolic blood pressure > 150 mmHg, or diastolic blood pressure > 100 mmHg), previous hypertensive crisis or hypertensive encephalopathy
- those with a known hereditary bleeding tendency or coagulation disorders; those who have received full-dose anticoagulant or thrombolytic therapy within 10 days prior to enrollment, or those who have taken non-steroidal anti-inflammatory drugs with platelet inhibitory effects within 10 days prior to enrollment (except for prophylactic use of low-dose aspirin (≤325 mg/day)).
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 |
|---|---|---|
| Adebrelimab Combined With Bevacizumab and Albumin PaclitaxelAdebrelimab is recommended to be administered with an infusion pump. The infusion pipeline is equipped with a 0.22-micron online filter membrane. Intravenous injection or bolus injection is not allowed. At the end of infusion, flush the infusion tube with sufficient 5% glucose or physiological saline, and do not share the same infusion tube with other drugs. In each treatment cycle, Adebrelimab should be given intravenously first. | Drug | Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel |
Primary outcome
6-month PFS rate
Time frame: 6 months
6-Month PFS Rates for Adebrelimab Combined with Bevacizumab and Albumin Paclitaxel in Patients with Advanced NSCLC Progressed by First-Line Immunotherapy Evaluated by Investigators
3 secondary outcomes
Progression-free survival (PFS)
Time frame: up to 12 months
Over survival (OS)
Time frame: up to 12 months
Disease control rate (DCR)
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
Related trials for 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
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung 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.
Xiaorong Dong, Dr. study chair
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel in people with Non-small Cell Lung Cancer, run by Xiaorong Dong 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 14 inclusion and 9 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 22 Feb 2023. 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.
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, Dr. (13986252286, xiaorongdong@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month PFS rate (time frame: 6 months). 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 22 Feb 2023.