Locally Advanced Squamous Non-small Cell Lung CancerPhase 2NCT06279754
Recombinant Human Endostatin Combined With Envafolimab and Synchronal Radiochemotherapy
A Phase 2 study testing Recombinant Human Endostatin Injection in people with Locally Advanced Squamous Non-small Cell Lung Cancer, run by The First Affiliated Hospital of Xinxiang Medical College.
Trial summary
This study is a prospective, single arm, single center open clinical study aimed at evaluating the efficacy and safety of recombinant human endostatin and envafolimab combined with synchronal radiochemotherapy in patients with locally advanced squamous non-small cell lung cancer who cannot undergo surgery in stage III. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locally Advanced Squamous Non-small Cell Lung Cancer
- What is being tested?
- Recombinant Human Endostatin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 18 Feb 2024to 18 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient voluntarily participated in this study, voluntarily underwent treatment and follow-up, and signed an informed consent form;
- According to the International Association for the Study of Lung Cancer and the Joint Committee on Cancer Classification, 8th edition of the TNM staging classification for lung cancer, locally advanced and unresectable stage III non-small cell lung cancer with histopathological diagnosis;
- According to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1), there should be at least one imaging measurable lesion; Patients who have not received PD-1/PD-L1 antibody treatment in the past.
- 18-70 years old; ECOG PS score: 0-1 points; Expected survival period exceeding 3 months;
- Main organ functions meet treatment standards
- Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study; Within 7 days prior to enrollment in the study, the serum or urine pregnancy test was negative and must be a non lactating patient; Men should agree to patients who must use contraceptive measures during the study period and within 6 months after the end of the study period.
Who cannot join
- Patients who have previously received PD-1/PD-L1 antibody treatment;
- Respiratory syndrome caused by pleural effusion or ascites (according to NCICTCAE classification ≥ grade 2 dyspnea;
- Patients with brain metastases accompanied by symptoms or symptom control time less than 2 months;
- Has experienced or currently suffers from other malignant tumors within 5 years;
- Within the first 4 weeks of grouping or during the medication period of this study, it is planned to undergo systemic anti-tumor therapy, including cytotoxic therapy and targeted drug therapy. Received radiotherapy within 4 weeks prior to grouping;
- Patients with any severe and/or uncontrolled diseases
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- Received significant surgical treatment, open biopsy, or obvious traumatic injury within 28 days prior to grouping;
- Patients with any signs of bleeding or medical history, regardless of severity; Within the first 4 weeks of grouping, patients with any bleeding or bleeding events ≥ CTCAE level 3, with unhealed wounds, ulcers, or fractures;
- Individuals who have experienced arterial/venous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism;
- Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;
- Participated in clinical trials of other anti-tumor drugs within four weeks;
- According to the researcher's judgment, there are accompanying diseases that seriously endanger patient safety or affect patient completion of the study;
About this study
Official title: Recombinant Human Endostatin Combined With Evafolimab Injection and Synchronal Radiochemotherapy for First-line Treatment of Locally Advanced Stage III Squamous Non-small Cell Lung Cancer
This study is a prospective, single arm, single center open clinical study aimed at evaluating the efficacy and safety of recombinant human endostatin and envafolimab combined with synchronal radiochemotherapy in patients with locally advanced squamous non-small cell lung cancer who cannot undergo surgery in stage III.
Read the detailed description
This study is a prospective, single arm, single center open clinical study aimed at evaluating the efficacy and safety of recombinant human endostatin and envafolimab combined with synchronal radiochemotherapy in patients with locally advanced squamous non-small cell lung cancer who cannot undergo surgery in stage III.
Patients with locally advanced stage III squamous non-small cell lung cancer who have not received systematic treatment in the past and cannot be treated surgically, after signing informed consent, qualified subjects who meet the inclusion criteria will be screened. They will receive 2 cycles of recombinant human endostatin combined with envafolimab and platinum containing chemotherapy. Radiotherapy will be carried out simultaneously in cycles 1-2, and after 2 cycles, they will receive maintenance treatment with envafolimab until the disease progresses and intolerable toxicity is detected, The treatment period does not exceed 12 months
- Being tested
- Recombinant Human Endostatin Injection
- Keywords
- recombinant human endostatin, envafolimab, synchronal radiochemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Endostatin InjectionDrug
Also called Evafolimab Injection
Recombinant Human Endostatin Injection：210 mg, intravenous infusion for 72 hours, once every three weeks cycle Evafolimab Injection：Subcutaneous injection on day 1, 8, and 15, once every three weeks cycle
| Study group | Role | What they receive |
|---|---|---|
| recombinant human endostatin Group | Experimental | Recombinant human endostatin and enrolizumab injection combined with Synchronal Radiochemotherapy Receives: Drug: Recombinant Human Endostatin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
After treatment, the ratio of patients assessed as CR and PR according to RECIST 1.1
Measured: After 6 weeks
Secondary outcomes (2)
Overall survival
The time from the start of treatment to death or last follow-up
Measured: The time from the start of treatment to death or last follow-up
Progression-free survival
The time from the start of treatment to the first recording of disease progression.
Measured: The time from the start of treatment to the first recording of disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start18 Feb 2024 (estimated)
- Primary completion18 Jun 2024 (estimated)
- Study completion18 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Squamous 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279754
- Sponsor's protocol ID
- ZLXGBXKYXM-031-01
- Status last verified
- Feb 2024
- First submitted
- 29 Jan 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share mid-term data results and final data analysis results
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Human Endostatin Combined With Evafolimab Injection and Synchronal Radiochemotherapy for First-line Treatment of Locally Advanced Stage III Squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06279754
- Acronym / sponsor ID
- ZLXGBXKYXM-031-01
- Keywords
- recombinant human endostatin, envafolimab, synchronal radiochemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- 18 Feb 2024 (estimated)
- Primary completion
- 18 Jun 2024 (estimated)
- Study completion
- 18 Dec 2025 (estimated)
- First posted
- 28 Feb 2024 (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, single center open clinical study aimed at evaluating the efficacy and safety of recombinant human endostatin and envafolimab combined with synchronal radiochemotherapy in patients with locally advanced squamous non-small cell lung cancer who cannot undergo surgery in stage III.
Detailed description
This study is a prospective, single arm, single center open clinical study aimed at evaluating the efficacy and safety of recombinant human endostatin and envafolimab combined with synchronal radiochemotherapy in patients with locally advanced squamous non-small cell lung cancer who cannot undergo surgery in stage III.
Patients with locally advanced stage III squamous non-small cell lung cancer who have not received systematic treatment in the past and cannot be treated surgically, after signing informed consent, qualified subjects who meet the inclusion criteria will be screened. They will receive 2 cycles of recombinant human endostatin combined with envafolimab and platinum containing chemotherapy. Radiotherapy will be carried out simultaneously in cycles 1-2, and after 2 cycles, they will receive maintenance treatment with envafolimab until the disease progresses and intolerable toxicity is detected, The treatment period does not exceed 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| recombinant human endostatin Group | Experimental | Drug: Recombinant Human Endostatin InjectionRecombinant human endostatin and enrolizumab injection combined with Synchronal Radiochemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient voluntarily participated in this study, voluntarily underwent treatment and follow-up, and signed an informed consent form;
- According to the International Association for the Study of Lung Cancer and the Joint Committee on Cancer Classification, 8th edition of the TNM staging classification for lung cancer, locally advanced and unresectable stage III non-small cell lung cancer with histopathological diagnosis;
- According to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1), there should be at least one imaging measurable lesion; Patients who have not received PD-1/PD-L1 antibody treatment in the past.
- 18-70 years old; ECOG PS score: 0-1 points; Expected survival period exceeding 3 months;
- Main organ functions meet treatment standards
Key exclusion criteria (12 listed)
- Patients who have previously received PD-1/PD-L1 antibody treatment;
- Respiratory syndrome caused by pleural effusion or ascites (according to NCICTCAE classification ≥ grade 2 dyspnea;
- Patients with brain metastases accompanied by symptoms or symptom control time less than 2 months;
- Has experienced or currently suffers from other malignant tumors within 5 years;
- Within the first 4 weeks of grouping or during the medication period of this study, it is planned to undergo systemic anti-tumor therapy, including cytotoxic therapy and targeted drug therapy. Received radiotherapy within 4 weeks prior to grouping;
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 |
|---|---|---|
| Recombinant Human Endostatin InjectionAlso: Evafolimab InjectionRecombinant Human Endostatin Injection：210 mg, intravenous infusion for 72 hours, once every three weeks cycle Evafolimab Injection：Subcutaneous injection on day 1, 8, and 15, once every three weeks cycle | Drug | recombinant human endostatin Group |
Primary outcome
objective response rate
Time frame: After 6 weeks
After treatment, the ratio of patients assessed as CR and PR according to RECIST 1.1
2 secondary outcomes
Overall survival
Time frame: The time from the start of treatment to death or last follow-up
Progression-free survival
Time frame: The time from the start of treatment to the first recording of disease progression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Yes. Share mid-term data results and final data analysis results
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Human Endostatin Injection in people with Locally Advanced Squamous 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 6 inclusion and 12 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 28 Feb 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: After 6 weeks). 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 28 Feb 2024.