Non-small Cell Lung CancerPhase 2NCT06182800
Adebrelimab Combined With Bevacizumab and Docetaxel for Advanced Non-Squamous Non-small Cell Lung Cancer After Progression on First-line Immunotherapy
A Phase 2 study testing Adebrelimab Combined with Bevacizumab and Docetaxel in people with Non-small Cell Lung Cancer, run by The First Affiliated Hospital of Xinxiang Medical College.
Trial summary
This study is a prospective, single-arm, multicenter, phase II clinical study to observe and evaluate the efficacy and safety of adebrelimab in combination with bevacizumab and docetaxel in patients with advanced non-squamous NSCLC after progression on first-line immunotherapy. 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 Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 27 Dec 2023to 30 Dec 2025
- 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 Tumor Node Metastasis (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 immune checkpoint inhibitor-containing therapy PFS of ≥ 6 months on first- line therapy.
- imaging evaluation (CT or MRI) with at least one measurable target lesion (according to RECIST v1.1) within 4 weeks prior to enrollment.
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- an ECOG PS score of 0-1 within 4 weeks prior to enrollment.
- an expected survival of ≥ 12 weeks.
- Adequate function of vital organs
- 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.
- 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 thrombosis in the 6 months
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- 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 docetaxel.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Study of Adebrelimab Combined With Bevacizumab and Docetaxel in the Treatment of Advanced Non-Squamous Non-small Cell Lung Cancer After Progression on First-line Immunotherapy
This study is a prospective, single-arm, multicenter, phase II clinical study to observe and evaluate the efficacy and safety of adebrelimab in combination with bevacizumab and docetaxel in patients with advanced non-squamous NSCLC after progression on first-line immunotherapy.
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, 1200 mg, Intravenous infusion, every 3 weeks (Q3W) + bevacizumab, 7.5 mg/kg, Intravenous infusion, Q3W +docetaxel 60-75 mg/m2, D1, Intravenous infusion, Q3W. docetaxel for 4 cycles, adebrelimab, bevacizumab use to progressive disease (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 Docetaxel
- 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 DocetaxelDrug
Adebrelimab: 1200 mg 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.
Docetaxel: 60-75 mg/m2 Docetaxel is given on days 1 of each cycle by intravenous infusion for 1 dosing cycle every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab Combined with Bevacizumab and Docetaxel | Experimental | Adebrelimab: 1200 mg 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.
Docetaxel: 60-75 mg/m2 Docetaxel is given on days 1 of each cycle by intravenous infusion for 1 dosing cycle every 3 weeks. Receives: Drug: Adebrelimab Combined with Bevacizumab and Docetaxel |
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 Docetaxel in Patients with Advanced Non-Squamous 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 18 months
objective response rate (ORR)
Number of cases with completed/partial response 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 posted27 Dec 2023
- Study start27 Dec 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2025 (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
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yinghua Ji, The First Affiliated Hospital of Xinxiang Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182800
- Sponsor's protocol ID
- KY202319
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Adebrelimab Combined With Bevacizumab and Docetaxel in the Treatment of Advanced Non-Squamous Non-small Cell Lung Cancer After Progression on First-line Immunotherapy
- ClinicalTrials.gov ID
- NCT06182800
- Acronym / sponsor ID
- KY202319
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- 27 Dec 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 27 Dec 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.
This study is a prospective, single-arm, multicenter, phase II clinical study to observe and evaluate the efficacy and safety of adebrelimab in combination with bevacizumab and docetaxel in patients with advanced non-squamous NSCLC after progression on first-line immunotherapy.
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, 1200 mg, Intravenous infusion, every 3 weeks (Q3W) + bevacizumab, 7.5 mg/kg, Intravenous infusion, Q3W +docetaxel 60-75 mg/m2, D1, Intravenous infusion, Q3W. docetaxel for 4 cycles, adebrelimab, bevacizumab use to progressive disease (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
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab Combined with Bevacizumab and Docetaxel | Experimental | Drug: Adebrelimab Combined with Bevacizumab and DocetaxelAdebrelimab: 1200 mg 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. Docetaxel: 60-75 mg/m2 Docetaxel is given on days 1 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 (10 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 Tumor Node Metastasis (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 immune checkpoint inhibitor-containing therapy PFS of ≥ 6 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.
- 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 DocetaxelAdebrelimab: 1200 mg 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. Docetaxel: 60-75 mg/m2 Docetaxel is given on days 1 of each cycle by intravenous infusion for 1 dosing cycle every 3 weeks. | Drug | Adebrelimab Combined with Bevacizumab and Docetaxel |
Primary outcome
6-month PFS rate
Time frame: 6 months
6-Month PFS Rates for Adebrelimab Combined with Bevacizumab and Docetaxel in Patients with Advanced Non-Squamous 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 18 months
objective response rate (ORR)
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 27 Dec 2023.
- Individual participant dataSharing planned: No
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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 Adebrelimab Combined with Bevacizumab and Docetaxel in people with Non-small Cell Lung Cancer, run by The First Affiliated Hospital of Xinxiang Medical College.
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 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 27 Dec 2023. 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 Ying hua Ji (13663030446, 54234317@qq.com), 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 27 Dec 2023.