Non Small Cell Lung CancerPhase 2NCT05448781
Recombinant Human Angioendostatin /PD-1 Mab Combined With First-line Chemotherapy in the Treatment of Driver Gene Negative Advanced NSCLC
A Phase 2 study testing Endostatin in people with Non Small Cell Lung Cancer and Endostatin, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 1 site in China.
Trial summary
To evaluate the efficacy and safety of recombinant human endostatin /PD-1 mab combined with first-line chemotherapy in the treatment of driver gene negative advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer, Endostatin
- What is being tested?
- Endostatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2022to 20 Dec 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients with any of the following conditions will not be enrolled in this study:
- Severe allergic reaction to humanized antibodies or fusion proteins;
- known hypersensitivity to Endu or any component contained in antibody preparations;
- Subjects have been diagnosed as immunodeficient or are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to the study's initial administration and are permitted to use physiological doses of glucocorticoids (≤10mg/ day of prednisone or equivalent);
- Subjects with active, known or suspected autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, and hypothyroidism, including but not limited to these diseases or syndromes) were excluded. Subjects with type 1 diabetes, hypothyroidism that requires only hormone replacement therapy, skin conditions that do not require systemic treatment (e.g: vitiligo, psoriasis, or hair loss), or conditions that are not expected to recur in the absence of an external trigger can be enrolled;
- Patients with pre-existing serious heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina pectoris, myocardial infarction, and severe valvular disease;
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- Patients who have previously received targeted drug therapy with vascular endothelial growth inhibitors, such as bevacizumab, sunitinib, sorafenib, imatinib, famitinib, rigafenib, apatinib, anlotinib, etc.
- Systemic antitumor therapy, including cytotoxic therapy, signal transduction inhibitors, or immunotherapy (or mitomycin C in the 6 weeks prior to receiving the study drug), was planned within 4 weeks prior to the group or during the duration of the study. Field expanding radiotherapy (EF-RT) was performed within 4 weeks prior to grouping or field limiting radiotherapy was performed within 2 weeks prior to grouping.
- Presence of active hepatitis B (HBV DNA ≥ 2000IU/ml or 104copies/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA higher than the lower limit of analysis).
- According to chest X-ray examination, sputum examination and clinical examination, active tuberculosis (TB) infection was determined. Patients with a history of active tuberculosis infection within the previous year, even if treated, should be excluded; Patients with a history of active tuberculosis infection more than one year ago should also be excluded unless the duration and type of antituberculosis therapy previously used are demonstrated to be appropriate.
- Patients with BMS with symptoms or symptom control for less than 2 months;
- Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before grouping;
- Patients whose imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study;
- Patients with any evidence or history of bleeding, regardless of severity; Patients with any bleeding or bleeding event ≥CTCAE grade 3 within 4 weeks prior to grouping had unhealed wounds, ulcers or fractures;
- Experienced arteriovenous/venous thrombosis events within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism;
- Concomitant diseases that, according to the investigator's judgment, seriously endanger the patient's safety or affect the patient's ability to complete the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, 51000
Chuan Jin, 020-66673634, jinchuan5959@163.com
Ye Song, 020-66671094, 565225131@qq.com
About this study
Official title: a Clinical Trial Phase II Prospective, Single-arm Study of Recombinant Human Angioendostatin /PD-1 Mab Combined With First-line Chemotherapy in the Treatment of Driver Gene Negative Advanced Non-small Cell Lung Cancer
To evaluate the efficacy and safety of recombinant human endostatin /PD-1 mab combined with first-line chemotherapy in the treatment of driver gene negative advanced non-small cell lung cancer.
Read the detailed description
This study is planned to enroll 38 eligible patients in China. Patients who fulfill all the inclusion criteria and none of the exclusion criteria will receive 4-6 cycles of endostatin combined with PD-1 antibody and platinum-containing two-drug chemotherapy.The efficacy of first-line treatment was evaluated every 6 weeks (2 cycles, 42 days). Patients with disease control (CR+ PR+SD) and tolerable adverse reactions were treated for 4-6 cycles,The maintenance treatment phase was continuous treatment with Endu combined with PD-1 antibody, and the efficacy was evaluated every 9 weeks until the end of the study when the investigator considered that the patient was not suitable for continued medication or the efficacy evaluation was disease progression (PD). No other antitumor therapy can be performed during the treatment period. Follow-up of survival was once every 3 months.
- Conditions
- Non Small Cell Lung Cancer, Endostatin
- Being tested
- Endostatin
- Keywords
- NSCLC, endostatin, PD-1 antibody
- 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.
EndostatinDrug
Also called Pemetrexed, Paclitaxel, Albumin paclitaxel, Carboplatin
Eligible patients with advanced NSCLC were treated with endostatin combined with Tirelizumab and platinum-containing two-drug chemotherapy.26 cases of non-squamous cell carcinoma were treated with endostatin combined with Tirelizumab and Pemetrexed+Carboplatin. and 12 cases of squamous cell carcinoma were treated with endostatin combined with Tirelizumab and Paclitaxel/Albumin paclitaxel+Carboplatin,The maintenance treatment phase was continuous treatment with Endu combined with Tirelizumab
| Study group | Role | What they receive |
|---|---|---|
| endostatin combined with PD-1 antibody and platinum-containing two-drug chemotherapy | Experimental | Recombinant human vascular endostatin (Endu): 210 mg (14 PCS), administered by continuous intravenous pumping for 72h every three weeks on the first day of each cycle.Pemetrexed: 500mg/m2, administered intravenously every three weeks on the first day of each cycle.Paclitaxel:175mg/ m2, administered intravenously every three weeks on the first day of each cycle.Albumin paclitaxel:260mg/ m2, administered intravenously every three weeks on the first day of each cycle.
Carboplatin:5/AUC, maximum dose limited to 600mg, or 75 mg/m2 cisplatin, is administered intravenously every three weeks on the first day of each cycle Tirelizumab: a recommended dose of 200mg/ time, administered every three weeks on the first day of each cycle until disease progression or unacceptable toxicity is developed. Receives: Drug: Endostatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
The time from the first date of first-line treatment until the date of objective disease progression or death.
Measured: 1 year
Secondary outcomes (2)
objective response rate (ORR)
Objective response rate after the given treatment in patients accoeding to the evaluation criteria of RECIST1.1
Measured: 1 year
Overall Survival (OS)
The time from the start of first-line treatment to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start20 Jul 2022 (estimated)
- Primary completion20 Jul 2023 (estimated)
- Study completion20 Dec 2023 (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
- endostatin combined with PD-1 antibody and platinum-containing two-drug chemotherapy
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448781
- Sponsor's protocol ID
- Endostatin0630
- Status last verified
- Jun 2022
- First submitted
- 4 Jul 2022
- Last updated
- 7 Jul 2022
- 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 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Clinical Trial Phase II Prospective, Single-arm Study of Recombinant Human Angioendostatin /PD-1 Mab Combined With First-line Chemotherapy in the Treatment of Driver Gene Negative Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05448781
- Acronym / sponsor ID
- Endostatin0630
- Conditions
- Non Small Cell Lung Cancer, Endostatin
- Keywords
- NSCLC, endostatin, PD-1 antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 20 Jul 2022 (estimated)
- Primary completion
- 20 Jul 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 7 Jul 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.
To evaluate the efficacy and safety of recombinant human endostatin /PD-1 mab combined with first-line chemotherapy in the treatment of driver gene negative advanced non-small cell lung cancer.
Detailed description
This study is planned to enroll 38 eligible patients in China. Patients who fulfill all the inclusion criteria and none of the exclusion criteria will receive 4-6 cycles of endostatin combined with PD-1 antibody and platinum-containing two-drug chemotherapy.The efficacy of first-line treatment was evaluated every 6 weeks (2 cycles, 42 days). Patients with disease control (CR+ PR+SD) and tolerable adverse reactions were treated for 4-6 cycles,The maintenance treatment phase was continuous treatment with Endu combined with PD-1 antibody, and the efficacy was evaluated every 9 weeks until the end of the study when the investigator considered that the patient was not suitable for continued medication or the efficacy evaluation was disease progression (PD). No other antitumor therapy can be performed during the treatment period. Follow-up of survival was once every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- endostatin combined with PD-1 antibody and platinum-containing two-drug chemotherapy
| Arm | Type | Receives |
|---|---|---|
| endostatin combined with PD-1 antibody and platinum-containing two-drug chemotherapy | Experimental | Drug: EndostatinRecombinant human vascular endostatin (Endu): 210 mg (14 PCS), administered by continuous intravenous pumping for 72h every three weeks on the first day of each cycle.Pemetrexed: 500mg/m2, administered intravenously every three weeks on the first day of each cycle.Paclitaxel:175mg/ m2, administered intravenously every three weeks on the first day of each cycle.Albumin paclitaxel:260mg/ m2, administered intravenously every three weeks on the first day of each cycle. Carboplatin:5/AUC, maximum dose limited to 600mg, or 75 mg/m2 cisplatin, is administered intravenously every three weeks on the first day of each cycle Tirelizumab: a recommended dose of 200mg/ time, administered every three weeks on the first day of each cycle until disease progression or unacceptable toxicity is developed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- Patients with any of the following conditions will not be enrolled in this study:
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 |
|---|---|---|
| EndostatinAlso: Pemetrexed, Paclitaxel, Albumin paclitaxel, CarboplatinEligible patients with advanced NSCLC were treated with endostatin combined with Tirelizumab and platinum-containing two-drug chemotherapy.26 cases of non-squamous cell carcinoma were treated with endostatin combined with Tirelizumab and Pemetrexed+Carboplatin. and 12 cases of squamous cell carcinoma were treated with endostatin combined with Tirelizumab and Paclitaxel/Albumin paclitaxel+Carboplatin,The maintenance treatment phase was continuous treatment with Endu combined with Tirelizumab | Drug | endostatin combined with PD-1 antibody and platinum-containing two-drug chemotherapy |
Primary outcome
Progression Free Survival
Time frame: 1 year
The time from the first date of first-line treatment until the date of objective disease progression or death.
2 secondary outcomes
objective response rate (ORR)
Time frame: 1 year
Overall Survival (OS)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- 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.
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 Endostatin in people with Non Small Cell Lung Cancer and Endostatin, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University 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 0 inclusion and 16 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 7 Jul 2022. 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 Chuan Jin (020-66673634, jinchuan5959@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 1 year). 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 7 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.