Lung NeoplasmsPhase 2NCT05203276
Envafolimab Combined With Endostar in the First-line Treatment of Advanced NSCLC
A Phase 2 study testing Envafolimab and Endostar in people with Lung Neoplasms, run by The First People's Hospital of Lianyungang at 1 site in China.
Trial summary
To evaluate the efficacy and safety of envafolimab combined with endostar in the first-line treatment of advanced Non-small Cell Lung Cancer With PD-L1 positive expression Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Envafolimab and Endostar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 30 Jun 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject voluntarily joins the study, can complete the signing of the informed consent form, and has good compliance;
- Age from 18 to 80 years old (when signing the informed consent form), both male and female;
- According to the 8th edition of the TNM staging classification of lung cancer by the International Association for the Research of Lung Cancer and the American Joint Committee on Cancer Classification, the driver gene (EGFR/ALK/ROS1) is negative and untreated patients with stage IIIB to IV NSCLC;
- Archived tumor tissue samples or newly obtained (without anti-tumor treatment since the biopsy) core or tumor lesions (not receiving radiotherapy) excised biopsy tissue have been provided. Formalin-fixed and paraffin-embedded (FFPE) tissue blocks are better than sections. The newly obtained biopsy tissue is better than the archived tissue, and the tissue samples are tested by immunohistochemistry for PD-L1 ≥ 1%;
- According to the evaluation criteria for the efficacy of solid tumors (RECIST Version 1.1), there is at least one imaging measurable lesion; that is, in CT or MRI detection, the longest diameter of a single lesion is ≥10mm, or the lymph node is pathologically enlarged, and a single lymph node is scanned by CT Short diameter ≥15mm;
- The Eastern Cooperative Oncology Group (ECOG) performance status score is 0-1;
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- The expected survival period is ≥3 months;
- Newly treated patients who have not received systematic anti-tumor therapy, including radiotherapy and chemotherapy, targeted and immunotherapy, or patients who relapse after follow-up after adjuvant chemotherapy for more than 6 months;
- With sufficient organ and bone marrow function, the laboratory test values within 7 days before entry into the group meet the following requirements (no blood components, cell growth factors, albumin and other corrective treatment drugs are allowed within the first 14 days of obtaining laboratory tests ),details as follows:
- 1) Blood routine: absolute neutrophil count (ANC) ≥1.5×109/L, platelet (PLT) ≥75×109/L, hemoglobin (HGB) ≥90 g/L (no blood transfusion or no red blood cells within 14 days) Genin-dependent); 2) Liver function: serum total bilirubin (TBIL) ≤2 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤5 times ULN, serum Albumin ≥28 g/L; Alkaline phosphatase (ALP) ≤5×ULN; 3) Renal function: Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥50 mL/min (using the standard Cockcroft-Gault formula): urine routine results show urine protein <2+; urine routine testing at baseline Patients who show urine protein ≥2+ should be collected for 24 hours and the quantification of 24-hour urine protein should be less than 1g; 4) Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; if the subject is receiving anticoagulation therapy, as long as the INR is within the intended use range of anticoagulant drugs; 10. For female subjects of childbearing age, a urine or serum pregnancy test should be performed 3 days before receiving the first study drug administration and the result is negative; 11. It is necessary to provide tissue samples for biomarker (such as PD-L1) analysis, preferably newly obtained tissues. Patients who cannot provide newly obtained tissues can provide 3-5μm-thick paraffin sections of tissues that are archived and saved within 2 years before enrollment. 5-8 sheets.
Who cannot join
- Imaging (CT or MRI) shows that the tumor has invaded large blood vessels or those who are judged to be very likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study;
- Currently participating in interventional clinical research treatment, or receiving treatment with other research drugs or research devices within 4 weeks before the first administration;
- Received Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration, or received major surgery within 3 weeks before the first administration;
- There are active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction and peritoneal metastasis that require clinical intervention;
- Regardless of the severity, patients with any signs of bleeding or medical history; patients with any bleeding or bleeding event ≥ CTCAE level 3 within 4 weeks before enrollment, unhealed wounds, ulcers or fractures;
- Grade III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmia;
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- Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, occurred within 6 months before being selected for treatment;
- Known to have allergic reactions to the drug in this study;
- Patients who require long-term systemic use of corticosteroids. Patients who require intermittent use of bronchodilators, inhaled corticosteroids, or local injections of corticosteroids due to COPD and asthma can be included in the group;
- Symptomatic central nervous system metastasis. Patients with asymptomatic brain metastases or brain metastases with stable symptoms after treatment can participate in this study as long as they meet all the following criteria: there are measurable lesions outside the central nervous system; no midbrain, pons, cerebellum, meninges, Medulla oblongata or spinal cord metastasis; maintain a clinically stable state for at least 2 weeks; stop hormone therapy 3 days before the first dose of study drug;
- There is an active infection that needs to be treated or systemic anti-infective drugs have been used within one week before the first administration;
- Before starting treatment, have not fully recovered from toxicity and/or complications caused by any intervention (ie, ≤ Grade 1 or reached baseline, excluding fatigue or hair loss);
- Known human immunodeficiency virus (HIV) infection history (ie HIV 1/2 antibody positive);
- Untreated active hepatitis B (defined as HBsAg positive and the number of copies of HBV-DNA detected at the same time is greater than the upper limit of the normal value of the laboratory department of the research center);
- Note: Hepatitis B subjects who meet the following criteria can also be included in the group:
- The HBV viral load before the first administration is less than 1000 copies/ml (200 IU/ml), and the subject should receive anti-HBV treatment during the entire study chemotherapy drug treatment period to avoid viral reactivation;
- For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), there is no need to receive preventive anti-HBV treatment, but close monitoring of virus reactivation is required.
- 15. Active HCV infected subjects (HCV antibody-positive and HCV-RNA level is higher than the lower limit of detection); 16. Live vaccine has been vaccinated within 30 days before the first administration (cycle 1, day 1); Note: It is allowed to receive inactivated virus vaccine for seasonal influenza within 30 days before the first administration; however, it is not allowed to receive live attenuated influenza vaccine for intranasal administration.
- 17. Pregnant or lactating women; 18. The medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the test results, prevent the subjects from participating in the study, or the investigator believes that it is not suitable for inclusion in the group. The investigator believes that there are other potential risks and is not suitable for participation this research.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First People'S Hospital of Lainyungang
Lianyungang, Jiangsu, 222000
Xiaodong Jiang, Doc
About this study
Official title: A Prospective, Multi-center, Single-arm Exploratory Clinical Study of Envafolimab Combined With Endostar in the First-line Treatment of Driver Gene-negative Advanced Non-small Cell Lung Cancer With PD-L1 Positive Expression
To evaluate the efficacy and safety of envafolimab combined with endostar in the first-line treatment of advanced Non-small Cell Lung Cancer With PD-L1 positive expression
Read the detailed description
Endostar indication: ENDOSTAR + NP chemotherapy regimen is used to treat Stage III/IV NSCLC patients either untreated or pretreated. This indication is based on a completed multi-center Phase III clinical trial.
Envafolimab indication: Envolimab is the world's first subcutaneous injection of PD-L1 monoclonal antibody.Suitable for adult patients with advanced solid tumors with unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defects (dMMR).
- Conditions
- Lung Neoplasms
- Being tested
- Envafolimab, Endostar
- Keywords
- Envafolimab, Endostar, NSCLC, PD-L1
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnvafolimabDrug
Also called EN WEI DA
300mg，SC，Q3W，d1
EndostarDrug
Also called ENDO
210mg，CIV，Q3W，d1-3
| Study group | Role | What they receive |
|---|---|---|
| Envafolimab+ Endostar Group | Experimental | Envafolimab（300mg，SC，Q3W，d1） Endostar（210mg，CIV 72h，Q3W，d1-3） Receives: Drug: Envafolimab; Drug: Endostar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit
Measured: up to 24 months
Number of participants with adverse events as a measure of safety and tolerability
From randomization until death (up to 24 months)
Measured: up to 24 months
Secondary outcomes (4)
PFS
Progression-free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
DCR
Disease Control Rate
Measured: Each 42 days up to intolerance the toxicity or PD (up to 24 months)
OS
Overall survival
Measured: From randomization until death (up to 24 months)
DOR
Duration of response
Measured: Each 42 days up to intolerance the toxicity or PD (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Mar 2022
- Primary completion30 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Lianyungang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaodong Jiang, Doc, Study chair, The First People's Hospital of Lianyungang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203276
- Sponsor's protocol ID
- Endouble
- Status last verified
- Jun 2023
- First submitted
- 6 Jan 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fukumura D, Kloepper J, Amoozgar Z, Duda DG, Jain RK. Enhancing cancer immunotherapy using antiangiogenics: opportunities and challenges. Nat Rev Clin Oncol. 2018 May;15(5):325-340. doi: 10.1038/nrclinonc.2018.29. Epub 2018 Mar 6.
PubMed 29508855Hockenhull K, Ortega-Franco A, Califano R. Pembrolizumab plus platinum-based chemotherapy for squamous non-small cell lung cancer: the new kid on the block. Transl Lung Cancer Res. 2021 Sep;10(9):3850-3854. doi: 10.21037/tlcr-20-715. No abstract available.
PubMed 34733633Borghaei H, Langer CJ, Paz-Ares L, Rodriguez-Abreu D, Halmos B, Garassino MC, Houghton B, Kurata T, Cheng Y, Lin J, Pietanza MC, Piperdi B, Gadgeel SM. Pembrolizumab plus chemotherapy versus chemotherapy alone in patients with advanced non-small cell lung cancer without tumor PD-L1 expression: A pooled analysis of 3 randomized controlled trials. Cancer. 2020 Nov 15;126(22):4867-4877. doi: 10.1002/cncr.33142. Epub 2020 Sep 11.
PubMed 32914866Jiang XD, Dai P, Wu J, Song DA, Yu JM. Effect of recombinant human endostatin on radiosensitivity in patients with non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2012 Jul 15;83(4):1272-7. doi: 10.1016/j.ijrobp.2011.09.050. Epub 2011 Nov 16.
PubMed 22099051
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Single-arm Exploratory Clinical Study of Envafolimab Combined With Endostar in the First-line Treatment of Driver Gene-negative Advanced Non-small Cell Lung Cancer With PD-L1 Positive Expression
- ClinicalTrials.gov ID
- NCT05203276
- Acronym / sponsor ID
- Endouble
- Conditions
- Lung Neoplasms
- Keywords
- Envafolimab, Endostar, NSCLC, PD-L1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First People's Hospital of LianyungangUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 24 Jan 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 envafolimab combined with endostar in the first-line treatment of advanced Non-small Cell Lung Cancer With PD-L1 positive expression
Detailed description
Endostar indication: ENDOSTAR + NP chemotherapy regimen is used to treat Stage III/IV NSCLC patients either untreated or pretreated. This indication is based on a completed multi-center Phase III clinical trial.
Envafolimab indication: Envolimab is the world's first subcutaneous injection of PD-L1 monoclonal antibody.Suitable for adult patients with advanced solid tumors with unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defects (dMMR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Envafolimab+ Endostar Group | Experimental | Drug: Envafolimab, Drug: EndostarEnvafolimab（300mg，SC，Q3W，d1） Endostar（210mg，CIV 72h，Q3W，d1-3） |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The subject voluntarily joins the study, can complete the signing of the informed consent form, and has good compliance;
- Age from 18 to 80 years old (when signing the informed consent form), both male and female;
- According to the 8th edition of the TNM staging classification of lung cancer by the International Association for the Research of Lung Cancer and the American Joint Committee on Cancer Classification, the driver gene (EGFR/ALK/ROS1) is negative and untreated patients with stage IIIB to IV NSCLC;
- Archived tumor tissue samples or newly obtained (without anti-tumor treatment since the biopsy) core or tumor lesions (not receiving radiotherapy) excised biopsy tissue have been provided. Formalin-fixed and paraffin-embedded (FFPE) tissue blocks are better than sections. The newly obtained biopsy tissue is better than the archived tissue, and the tissue samples are tested by immunohistochemistry for PD-L1 ≥ 1%;
- According to the evaluation criteria for the efficacy of solid tumors (RECIST Version 1.1), there is at least one imaging measurable lesion; that is, in CT or MRI detection, the longest diameter of a single lesion is ≥10mm, or the lymph node is pathologically enlarged, and a single lymph node is scanned by CT Short diameter ≥15mm;
Key exclusion criteria (19 listed)
- Imaging (CT or MRI) shows that the tumor has invaded large blood vessels or those who are judged to be very likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study;
- Currently participating in interventional clinical research treatment, or receiving treatment with other research drugs or research devices within 4 weeks before the first administration;
- Received Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration, or received major surgery within 3 weeks before the first administration;
- There are active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction and peritoneal metastasis that require clinical intervention;
- Regardless of the severity, patients with any signs of bleeding or medical history; patients with any bleeding or bleeding event ≥ CTCAE level 3 within 4 weeks before enrollment, unhealed wounds, ulcers or fractures;
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 |
|---|---|---|
| EnvafolimabAlso: EN WEI DA300mg，SC，Q3W，d1 | Drug | Envafolimab+ Endostar Group |
| EndostarAlso: ENDO210mg，CIV，Q3W，d1-3 | Drug | Envafolimab+ Endostar Group |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 24 months
The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit
Number of participants with adverse events as a measure of safety and tolerability
Time frame: up to 24 months
From randomization until death (up to 24 months)
4 secondary outcomes
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
DCR
Time frame: Each 42 days up to intolerance the toxicity or PD (up to 24 months)
OS
Time frame: From randomization until death (up to 24 months)
DOR
Time frame: Each 42 days up to intolerance the toxicity or PD (up to 24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Background: PubMed 29508855Fukumura D, Kloepper J, Amoozgar Z, Duda DG, Jain RK. Enhancing cancer immunotherapy using antiangiogenics: opportunities and challenges. Nat Rev Clin Oncol. 2018 May;15(5):325-340. doi: 10.1038/nrclinonc.2018.29. Epub 2018 Mar 6.
- Background: PubMed 34733633Hockenhull K, Ortega-Franco A, Califano R. Pembrolizumab plus platinum-based chemotherapy for squamous non-small cell lung cancer: the new kid on the block. Transl Lung Cancer Res. 2021 Sep;10(9):3850-3854. doi: 10.21037/tlcr-20-715. No abstract available.
- Background: PubMed 32914866Borghaei H, Langer CJ, Paz-Ares L, Rodriguez-Abreu D, Halmos B, Garassino MC, Houghton B, Kurata T, Cheng Y, Lin J, Pietanza MC, Piperdi B, Gadgeel SM. Pembrolizumab plus chemotherapy versus chemotherapy alone in patients with advanced non-small cell lung cancer without tumor PD-L1 expression: A pooled analysis of 3 randomized controlled trials. Cancer. 2020 Nov 15;126(22):4867-4877. doi: 10.1002/cncr.33142. Epub 2020 Sep 11.
- Results publication: PubMed 22099051Jiang XD, Dai P, Wu J, Song DA, Yu JM. Effect of recombinant human endostatin on radiosensitivity in patients with non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2012 Jul 15;83(4):1272-7. doi: 10.1016/j.ijrobp.2011.09.050. Epub 2011 Nov 16.
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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.
Xiaodong Jiang, Doc study chair
The First People's Hospital of Lianyungang
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 Envafolimab and Endostar in people with Lung Neoplasms, run by The First People's Hospital of Lianyungang 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 10 inclusion and 19 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 22 Jun 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 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 Xiaodong Jiang, Doc (86-0518-85469074, jxdysy1970@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: up to 24 months). The study lists 2 primary outcomes in all. 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 NCT05203276, which also lists 4 linked publications.
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 22 Jun 2023.