Non-small Cell Lung CancerPhase 2NCT06618391

Local Injection and Systemic Therapy in the Treatment of NSCLC.

A Phase 2 study testing Envafolimab, Recombinant human endostatin and recombinant human adenovirus type 5 in people with Non-small Cell Lung Cancer, run by Henan Cancer Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This study is a prospective, exploratory Phase II clinical study aimed at evaluating the safety and efficacy of Envafolimab and recombinant human endostatin and Recombinant Human Adenovirus Type 5 Intratumor local injection combined with systemic therapy in patients with locally advanced or advanced non-small cell… 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?: Envafolimab, Recombinant human endostatin and recombinant human adenovirus type 5
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: No sites listed yet
Study dates: 8 Oct 2024to 30 Oct 2026
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

Volunteer to participate and sign the informed consent form；
≥ 18 years old; Both men and women are eligible；
Histologically or cytologically confirmed advanced or metastatic locally advanced, advanced (Stage IIIB, IIIC, or IV) NSCLC without mutations in driver gene testing;
Patients with recurrent or metastatic NSCLC who have previously failed first-line standard therapy;
According to Response Evaluation Criteria in Solid Tumors (RECIST1.1), there should be at least one measurable lesion as a target lesion, and the measurable lesion should not have received local therapy such as radiotherapy;
Atelectasis Radiographically assessed atelectasis with at least one lobe;

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Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Expected survival ≥3 months;
Major organ functions within 7 days prior to treatment meeting the following criteria:(1) Blood routine examination criteria (without blood transfusion within 14 days) : ① Hemoglobin (HB) ≥90g/L; ② absolute neutrophil count (ANC) ≥1.5×10^9/L; ③ Platelet (PLT) ≥80×10^9/L. (2) Biochemical examination should meet the following criteria: ① Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); ② Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×ULN, if accompanied by liver metastasis, ALT and AST≤5×ULN; ③ Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr)≥60ml/min; ④ Serum albumin ≥35g/L. (3) Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF)≥lower limit of normal (50%).
For female subjects of childbearing potential, a negative urine or serum pregnancy test should be obtained 3 days prior to receiving the first dose of study drug;
Subject and subject sexual partner need to use contraceptive measures (eg intrauterine device, contraceptive pill , or condom) during the study treatment period and for 6 months after the end of the study treatment period;

Who cannot join

Severe metamorphosis/allergic reaction to humanized antibodies or fusion proteins;
Known hypersensitivity to Endostar or any component of the antibody formulation;
Diagnosis of immunodeficiency or ongoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of study, physiological doses of glucocorticoids (≤ 10 mg/day prednisone or equivalent) are permitted;
Exclude subjects with active, known, or suspected autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hypothyroidism, including but not limited to these diseases or syndromes). Subjects who have type 1 diabetes, hypothyroidism requiring 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 external triggers may be enrolled;
Patients with severe heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe heart valve disease;
Patients who have previously received targeted therapy with vascular endothelial growth inhibitors, such as bevacizumab, Sunitinib, sorafenib, imatinib, Famitinib, Regafenib, Apatinib, androtinib, etc.

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Systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C within 6 weeks prior to receiving trial drug) planned within 4 weeks prior to group assignment or during this study. Expansion field radiotherapy (EF-RT) within 4 weeks before grouping or limited field radiotherapy to assess tumor lesions within 2 weeks before grouping;
Active hepatitis B (HBV DNA ≥ 2000IU/ml or 104copies/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the lower limit of assay);
Active pulmonary tuberculosis (TB) infection was judged based on chest X-ray, sputum examination, and clinical examination. Patients with a history of active pulmonary tuberculosis infection within the previous year, even if treated, were excluded; patients with a history of active pulmonary tuberculosis infection more than 1 year ago, unless the course and type of anti-tuberculosis treatment previously used were proven to be appropriate.
Patients with brain metastases accompanied by symptoms or symptom control time less than 2 months;
Received significant surgical treatment, open biopsy, or obvious traumatic injury within 28 days prior to grouping;
imaging showed that the tumor has invaded important blood vessels or the investigator judged that the tumor is likely to invade important blood vessels during the subsequent study period and cause fatal bleeding;
regardless of severity, patients with any signs of bleeding constitution or medical history; within 4 weeks before grouping, patients with any bleeding or bleeding events ≥ CTCAE grade 3, with unhealed wounds, ulcers or fractures;
Hyperarterial/venous thrombotic events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism;
According to the investigator 's judgment, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study.

Trial locations and contacts

No sites are listed yet.

Hongbo Wu, M.D. contact

15981878778

zlyywuhongbo1417@zzu.edu.cn

About this study

Official title: Envafolimab and Recombinant Human Endostatin and Recombinant Human Adenovirus Type 5 Intratumor Local Injection Combined With Systemic Therapy in Patients With Advanced NSCLC :a Prospective, Exploratory Phase II Clinical Study Tudy

Read the detailed description

Patients with pathologically confirmed unresectable locally advanced/advanced NSCLC with atelectasis were screened and eligible subjects were randomized to receive local intratumoral injection of envolumab/Endostar/recombinant human adenovirus type 5 H101 combined with systemic therapy after signing informed consent.

Conditions: Non-small Cell Lung Cancer
Being tested: Envafolimab, Recombinant human endostatin, recombinant human adenovirus type 5
Keywords: Envafolimab, Recombinant human endostatin, Recombinant Human Adenovirus Type 5, Intratumor local injection, NSCLC
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.

EnvafolimabDrug
Also called PD-L1
Envolimab :150 mg/time, intratumoral injection, at least 5 sites; Recombinant human endostatin： Q3W for 4-6 cycles，Maintenance therapy 210 mg ,CIV 72 hours ,administered as continuous intravenous pump, administered on Day 1 of each cycle; Docetaxel: 60-75 mg/m2, D1, Q3W,for 4-6 cycles，intravenous drip.
Recombinant human endostatinDrug
Also called Endostar
Recombinant human endostatin: 15mg/time, intratumoral injection, at least 5 sites; Envolimab :Maintenance therapy 300 mg, Q3W for 4-6 cycles，, subcutaneous injection; administered on Day 1 of each cycle; Docetaxel: 60-75 mg/m2, D1, Q3W,for 4-6 cycles，intravenous drip.
recombinant human adenovirus type 5Drug
Also called OncorineR
Recombinant Human Adenovirus Type 5: 1.0ml/time, intratumoral injection, at least 5 sites; Envolimab :Maintenance therapy 300 mg, Q3W for 4-6 cycles，, subcutaneous injection; administered on Day 1 of each cycle; Docetaxel: 60-75 mg/m2, D1, Q3W,for 4-6 cycles，intravenous drip.

Study groups in NCT06618391
Study group	Role	What they receive
Envafolimab	Experimental	Envafolimab 150 mg Q3W (maximum 2 cycles of intratumoral therapy) was injected intratumorally on days 1 and 8, combined with chemotherapy + Recombinant human endostatin Q3W for 4-6 cycles; Receives: Drug: Envafolimab
Recombinant human endostatin	Experimental	Intratumoral injection of Recombinant human endostatin15mg Q3W (maximum 2 cycles of intratumoral therapy) on Days 1 and 8; combined chemotherapy + Enbrelizumab Q3W for 4-6 cycles. Receives: Drug: Recombinant human endostatin
Recombinant human adenovirus type 5	Experimental	1.0 ml of recombinant human adenovirus type 5 injected intratumorally on days 1 and 8, Q3W (maximum 2 cycles of intratumoral therapy); combined chemotherapy + envolumab, Q3W, 4-6 cycles of treatment. Receives: Drug: recombinant human adenovirus type 5

What is being measured

The primary outcome is the main question the study is designed to answer.

lung recruitment rate
Imaging studies showed that the lesion dissipated or atelectasis was reduced by 50%
Measured: every 3 weeks during intratumoral treatment in the first two cycles,At the end of Cycle 1and Cycle2 (each cycle is 281days).

Secondary outcomes (6)

ORR（Objective response rate）
ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR assessed by the investigator according to RECIST version 1.1
Measured: Assessed every 6 weeks （within 1 year）or every 9 weeks （1 year later）up to disease progression or death or up to 2 years
DCR（Disease control rate）
DCR was defined as the percentage of CR+PR+SD assessed by the investigator according to RECIST version 1.1
Measured: Assessed every 6 weeks （within 1 year）or every 9 weeks （1 year later）up to disease progression or death or up to 2 years
PFS（Progression-free survival）
PFS was defined as the time from first dose to first documented disease progression (PD) or death from any cause, whichever occurred first.
Measured: Assessed every 6 weeks （within 1 year）or every 9 weeks （1 year later）up to disease progression or death or up to 2 years
OS（Overall survival）
OS was defined as the time from first dose to death for any cause
Measured: up to 2 years
RFS（Recurrence free survival）
RFS was defined as the time from CR to disease progression (PD) or death or up to years, from any cause, whichever occurred first.
Measured: Assessed every 6 weeks （within 1 year）or every 9 weeks （1 year later）up to disease progression or death or up to 2 years
EORTC QLQ-C30 scale
The European O-rganization for Reasearch and Treatment of Cancer Quality of Life Questionnare-core 30,There are 30 items in total, of which 29 and 30 items are divided into 7 grades, marked as 1-7 points according to the options, and other items are divided into 4 grades, marked as 1-4 points according to the options.High or low score do not mean a better or worse outcome.
Measured: up to disease progression or 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 202430 Oct 2026

First posted1 Oct 2024
Study start8 Oct 2024 (estimated)
Primary completion2 Mar 2026 (estimated)
Study completion30 Oct 2026 (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.
More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 84 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06618391
Sponsor's protocol ID: ERR-NSCLC-01
Status last verified: Sep 2024
First submitted: 8 Sep 2024
Last updated: 1 Oct 2024
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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Envafolimab and Recombinant Human Endostatin and Recombinant Human Adenovirus Type 5 Intratumor Local Injection Combined With Systemic Therapy in Patients With Advanced NSCLC :a Prospective, Exploratory Phase II Clinical Study Tudy
ClinicalTrials.gov ID: NCT06618391
Acronym / sponsor ID: ERR-NSCLC-01
Conditions: Non-small Cell Lung Cancer
Keywords: Envafolimab, Recombinant human endostatin, Recombinant Human Adenovirus Type 5, Intratumor local injection, NSCLC
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 84 participants (estimated)
Lead sponsor: Henan Cancer HospitalOther government
Study start: 8 Oct 2024 (estimated)
Primary completion: 2 Mar 2026 (estimated)
Study completion: 30 Oct 2026 (estimated)
First posted: 1 Oct 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Envafolimab	Experimental	Drug: EnvafolimabEnvafolimab 150 mg Q3W (maximum 2 cycles of intratumoral therapy) was injected intratumorally on days 1 and 8, combined with chemotherapy + Recombinant human endostatin Q3W for 4-6 cycles;
Recombinant human endostatin	Experimental	Drug: Recombinant human endostatinIntratumoral injection of Recombinant human endostatin15mg Q3W (maximum 2 cycles of intratumoral therapy) on Days 1 and 8; combined chemotherapy + Enbrelizumab Q3W for 4-6 cycles.
Recombinant human adenovirus type 5	Experimental	Drug: recombinant human adenovirus type 51.0 ml of recombinant human adenovirus type 5 injected intratumorally on days 1 and 8, Q3W (maximum 2 cycles of intratumoral therapy); combined chemotherapy + envolumab, Q3W, 4-6 cycles of treatment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Volunteer to participate and sign the informed consent form；
≥ 18 years old; Both men and women are eligible；
Histologically or cytologically confirmed advanced or metastatic locally advanced, advanced (Stage IIIB, IIIC, or IV) NSCLC without mutations in driver gene testing;
Patients with recurrent or metastatic NSCLC who have previously failed first-line standard therapy;
According to Response Evaluation Criteria in Solid Tumors (RECIST1.1), there should be at least one measurable lesion as a target lesion, and the measurable lesion should not have received local therapy such as radiotherapy;

Key exclusion criteria (15 listed)

Severe metamorphosis/allergic reaction to humanized antibodies or fusion proteins;
Known hypersensitivity to Endostar or any component of the antibody formulation;
Diagnosis of immunodeficiency or ongoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of study, physiological doses of glucocorticoids (≤ 10 mg/day prednisone or equivalent) are permitted;
Exclude subjects with active, known, or suspected autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hypothyroidism, including but not limited to these diseases or syndromes). Subjects who have type 1 diabetes, hypothyroidism requiring 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 external triggers may be enrolled;
Patients with severe heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe heart valve disease;

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: PD-L1Envolimab :150 mg/time, intratumoral injection, at least 5 sites; Recombinant human endostatin： Q3W for 4-6 cycles，Maintenance therapy 210 mg ,CIV 72 hours ,administered as continuous intravenous pump, administered on Day 1 of each cycle; Docetaxel: 60-75 mg/m2, D1, Q3W,for 4-6 cycles，intravenous drip.	Drug	Envafolimab
Recombinant human endostatinAlso: EndostarRecombinant human endostatin: 15mg/time, intratumoral injection, at least 5 sites; Envolimab :Maintenance therapy 300 mg, Q3W for 4-6 cycles，, subcutaneous injection; administered on Day 1 of each cycle; Docetaxel: 60-75 mg/m2, D1, Q3W,for 4-6 cycles，intravenous drip.	Drug	Recombinant human endostatin
recombinant human adenovirus type 5Also: OncorineRRecombinant Human Adenovirus Type 5: 1.0ml/time, intratumoral injection, at least 5 sites; Envolimab :Maintenance therapy 300 mg, Q3W for 4-6 cycles，, subcutaneous injection; administered on Day 1 of each cycle; Docetaxel: 60-75 mg/m2, D1, Q3W,for 4-6 cycles，intravenous drip.	Drug	Recombinant human adenovirus type 5

Primary outcome

lung recruitment rate
Time frame: every 3 weeks during intratumoral treatment in the first two cycles,At the end of Cycle 1and Cycle2 (each cycle is 281days).
Imaging studies showed that the lesion dissipated or atelectasis was reduced by 50%

6 secondary outcomes

ORR（Objective response rate）
Time frame: Assessed every 6 weeks （within 1 year）or every 9 weeks （1 year later）up to disease progression or death or up to 2 years
DCR（Disease control rate）
Time frame: Assessed every 6 weeks （within 1 year）or every 9 weeks （1 year later）up to disease progression or death or up to 2 years
PFS（Progression-free survival）
Time frame: Assessed every 6 weeks （within 1 year）or every 9 weeks （1 year later）up to disease progression or death or up to 2 years
OS（Overall survival）
Time frame: up to 2 years
RFS（Recurrence free survival）
Time frame: Assessed every 6 weeks （within 1 year）or every 9 weeks （1 year later）up to disease progression or death or up to 2 years
EORTC QLQ-C30 scale
Time frame: up to disease progression or 2 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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.

Hongbo Wu, M.D. contact

15981878778

zlyywuhongbo1417@zzu.edu.cn

Hongbo Wu, M.D. principal investigator

Henan Cancer Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Envafolimab, Recombinant human endostatin and recombinant human adenovirus type 5 in people with Non-small Cell Lung Cancer, run by Henan Cancer Hospital.

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 11 inclusion and 15 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 1 Oct 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?

Contact Hongbo Wu, M.D. (15981878778, zlyywuhongbo1417@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

lung recruitment rate (time frame: every 3 weeks during intratumoral treatment in the first two cycles,At the end of Cycle 1and Cycle2 (each cycle is 281days).). 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 NCT06618391.

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 1 Oct 2024.