Carcinoma, Non-Small-Cell LungPhase 3NCT05104281
Osimertinib Combined With Bevacizumab in Patients With Brain Metastasis Epidermal Growth Factor Receptor (EGFR) Mutation Positive Metastatic Non-Small Cell Lung Cancer
A Phase 3 study testing osimertinib oral and bevazizumab intravenously in people with Carcinoma, Non-Small-Cell Lung, run by Qingdao Central Hospital at 1 site in China.
Trial summary
There is no positive data on osimertinib in the treatment of metastatic EGFR mutation positive non-small-cell lung cancer (NSCLC). The purpose of this study is to study osimertinib combined with bevacizumab in the management of patients with brain metastasis harboring EGFR mutation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- osimertinib oral and bevazizumab intravenously
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2024
- Phase
- Phase 3
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must have histologically or cytologically confirmed, metastatic, nonsquamous non-small cell lung cancer (NSCLC) Partipiant harboring primary epidermal growth factor receptor (EGFR) Exon 18-21 mutation and brain metastasis.
- Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, or 2.
- Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream.
- A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.
Who cannot join
- Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation.
- Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis.
- Participant has a contraindication to the use Osimertinib or Bevacizumab.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qingdao Central Hospital, Qingdao Cancer Hospital
Qingdao, Shandong, 266042
youxin ji, M.D., 8653268665078, mdji001@gmail.com
chunling zhang, M.D.
About this study
There is no positive data on osimertinib in the treatment of metastatic EGFR mutation positive non-small-cell lung cancer (NSCLC). The purpose of this study is to study osimertinib combined with bevacizumab in the management of patients with brain metastasis harboring EGFR mutation.
Read the detailed description
Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer (almost 20 percent [%] of cancer deaths); NSCLC accounts for 80% to 85% of lung cancers. The hypothesis is that osimertinib combined bevacizumab in patients with advanced NSCLC patients with brain metastasis characterized by EGFR mutations . Efficacy assessments will include disease assessment, symptomatic progression and patient-reported outcome. Safety assessments will include physical examinations, vital signs, electrocardiograms (ECGs), Eastern Cooperative Oncology Group (ECOG) performance status and clinical safety laboratory assessments (serum chemistry, hematology, coagulation, and urinalysis).
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- osimertinib oral and bevazizumab intravenously
- Keywords
- Bronchial Neoplasms, EGFR Mutation, Osimertinib, Bevacizumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Bronchial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osimertinib oral and bevazizumab intravenouslyDrug
Also called bevacizumab, osimertinib
osimertinib 80mg, oral daily and bevacizumab 15mg/KG body weight intravenously infusion every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| study drug | Experimental | osimertinib 80 mg, oral daily and bevacizumab 15mg/KG body weight intravenously infusion every 21 days Receives: Drug: osimertinib oral and bevazizumab intravenously |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review (BICR)
Measured: 30 months
Secondary outcomes (2)
OS
Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.
Measured: Up to 48 months
ORR
ORR is defined as the percentage of participants who achieve either a complete response (CR) or partial response (PR) as defined by BICR using RECIST v1.1 criteria.
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104281
- Sponsor's protocol ID
- QDCH2021-10-01
- Status last verified
- Mar 2023
- First submitted
- 21 Oct 2021
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Zhang L, You Y, Liu X, Liu F, Nie K, Ji Y. Osimertinib combined with bevacizumab as the first-line treatment in non-small cell lung cancer patients with brain metastasis harboring epidermal growth factor receptor mutations. Thorac Cancer. 2023 May;14(15):1355-1361. doi: 10.1111/1759-7714.14880. Epub 2023 Apr 5.
PubMed 37016906
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osimertinib Combined With Bevacizumab in Patients With Brain Metastasis Epidermal Growth Factor Receptor (EGFR) Mutation Positive Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05104281
- Acronym / sponsor ID
- QDCH2021-10-01
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Bronchial Neoplasms, EGFR Mutation, Osimertinib, Bevacizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Qingdao Central HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Nov 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.
There is no positive data on osimertinib in the treatment of metastatic EGFR mutation positive non-small-cell lung cancer (NSCLC). The purpose of this study is to study osimertinib combined with bevacizumab in the management of patients with brain metastasis harboring EGFR mutation.
Detailed description
Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer (almost 20 percent [%] of cancer deaths); NSCLC accounts for 80% to 85% of lung cancers. The hypothesis is that osimertinib combined bevacizumab in patients with advanced NSCLC patients with brain metastasis characterized by EGFR mutations . Efficacy assessments will include disease assessment, symptomatic progression and patient-reported outcome. Safety assessments will include physical examinations, vital signs, electrocardiograms (ECGs), Eastern Cooperative Oncology Group (ECOG) performance status and clinical safety laboratory assessments (serum chemistry, hematology, coagulation, and urinalysis).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study drug | Experimental | Drug: osimertinib oral and bevazizumab intravenouslyosimertinib 80 mg, oral daily and bevacizumab 15mg/KG body weight intravenously infusion every 21 days |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant must have histologically or cytologically confirmed, metastatic, nonsquamous non-small cell lung cancer (NSCLC) Partipiant harboring primary epidermal growth factor receptor (EGFR) Exon 18-21 mutation and brain metastasis.
- Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, or 2.
- Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream.
- A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.
Key exclusion criteria (3 listed)
- Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation.
- Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis.
- Participant has a contraindication to the use Osimertinib or Bevacizumab.
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 |
|---|---|---|
| osimertinib oral and bevazizumab intravenouslyAlso: bevacizumab, osimertinibosimertinib 80mg, oral daily and bevacizumab 15mg/KG body weight intravenously infusion every 21 days. | Drug | study drug |
Primary outcome
PFS
Time frame: 30 months
Progression-Free Survival (PFS) According to RECIST v1.1 as Assessed by Blinded Independent Central Review (BICR)
2 secondary outcomes
OS
Time frame: Up to 48 months
ORR
Time frame: Up to 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Derived from this study: PubMed 37016906Zhang L, You Y, Liu X, Liu F, Nie K, Ji Y. Osimertinib combined with bevacizumab as the first-line treatment in non-small cell lung cancer patients with brain metastasis harboring epidermal growth factor receptor mutations. Thorac Cancer. 2023 May;14(15):1355-1361. doi: 10.1111/1759-7714.14880. Epub 2023 Apr 5.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing osimertinib oral and bevazizumab intravenously in people with Carcinoma, Non-Small-Cell Lung, run by Qingdao Central Hospital 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 5 inclusion and 3 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 29 Mar 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05104281, which also lists 1 linked publication.
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 29 Mar 2023.