Trial Title:
Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel in Non-squamous NSCLC After First-line Treatment
NCT ID:
NCT05738317
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Bevacizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Patients with advanced non-squamous non-small cell lung cancer after first-line
immunotherapy progression
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel
Description:
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.
Arm group label:
Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. voluntarily enrolled in this study and signed the Informed Consent Form (ICF).
2. age ≥ 18 years and both sexes
3. 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.
4. objective imaging progression (RECIST v1.1 assessment) after subjects have received
a first-line regimen containing immune checkpoint inhibitor therapy.
5. the best outcome of first-line immune checkpoint inhibitor-containing therapy is SD,
PR, CR, and PFS of ≥ 3 months on first-line therapy.
6. imaging evaluation (CT or MRI) with at least one measurable target lesion (according
to RECIST v1.1 criteria) within 4 weeks prior to enrollment.
7. an ECOG PS score of 0-1 within 4 weeks prior to enrollment.
8. an expected survival of ≥ 12 weeks.
9. 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).
(2) 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.
(3) 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.
(4) 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.
(5) 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.
Exclusion Criteria:
1. 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)
2. 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.
3. 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)
4. 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
5. 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)).
6. 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
7. 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.
8. those with severe vascular lesions (including aneurysms or arterial thrombosis
requiring surgical treatment) within 6 months prior to enrollment
9. 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Union hospital
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaorong Dong, Dr.
Start date:
December 1, 2022
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Xiaorong Dong
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05738317
