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TerminatedNCT07897019Updated Oct 27, 2026

Efficacy and Safety of Almonertinib Combined With Recombinant Human Endostatin in the Treatment of Stage IIIB-IV Non-small Cell Lung Cancer

An observational study in Non-Small Cell Lung Cancer, sponsored by Three Gorges Hospital of Chongqing University. Terminated at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Three Gorges Hospital of Chongqing University · Observational

Why this study was terminated
The study was terminated early due to slow participant accrual. Enrollment targets could not be met within a feasible timeframe. The decision was not related to any safety concerns.
Updated Oct 27, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,877 studies in Carcinoma, Non-Small-Cell Lung with a site in China — 762 open to participants now, 985 under way, 203 of them phase 3. Carcinoma, Non-Small-Cell Lung · China.

Enrollment
282nd of 286
1 · median 200
Started
2024
with 202 others
Observational
286 of 1,877
114 open now
Registered
1,365th of 1,877
by date

Among the 1,877 studies in Carcinoma, Non-Small-Cell Lung with a site in China, this one is the 282nd largest by enrollment of the 286 observational ones that give a count, is one of 203 that started in 2024, is one of 286 observational ones, and was the 1,365th registered.

Carcinoma, Non-Small-Cell Lung

7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.

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Open to participants now

762 of the 1,877 studies in Carcinoma, Non-Small-Cell Lung with a site in China are open now. Recruiting first, the newest first:

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A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 1,324 Carcinoma, Non-Small-Cell Lung studies recruiting now, 986 (74%) set no upper age limit and 226 (17%) stop at 75 or younger; 34 take children under 18; 39 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

Rationale:

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer in the world, and patients with stage IIIB-IV have a poor prognosis. EGFR mutations, especially the 19th amino acid deletion (19del) and the 21st amino acid L858R mutation, are the most common types of gene mutations in NSCLC. These mutations usually lead to overactivity of EGFR, thereby stimulating excessive proliferation of lung cancer cells. At present, the conventional treatment for such patients is mainly the use of EGFR tyrosine kinase inhibitors (EGFR-TKIs) for treatment. However, although EGFR-TKIs have achieved certain results in the treatment of NSCLC patients with EGFR mutations, their treatment effects are often difficult to sustain due to the resistance of patients to these drugs. Therefore, finding new treatment strategies to improve the survival rate and quality of life of such patients is an important current research direction. The results of many studies suggest that EGFR TKIs and anti-angiogenic drugs can inhibit tumors from different signaling pathways. EGFR-TKIs can inhibit the epidermal growth factor receptor pathway and inhibit tumor growth; anti-angiogenic drugs inhibit tumor angiogenesis by binding to vascular endothelial growth factor (VEGF). At the same time, the combination of the two has a synergistic effect. Both EGFR and VEGFR-2 signaling pathways can trigger downstream signaling pathways such as PI3K/AKT and RAS/RAF/ERK, affecting cell proliferation. EGFR activation can also drive HIF-1α upregulation, leading to VEGF gene expression. Many clinical studies have confirmed that the A+T treatment model can improve the efficacy of EGFR-positive NSCLC.

Methods:

This study is planned to adopt a mixed design. We will prospectively collect new patient data and retrospectively analyze existing patient data. In the prospective part, we will treat patients with stage IIIB-IV NSCLC with EGFR amino acid 21 L858R mutation and amino acid 19 deletion (19del) with a combination of ametinib mesylate (AUMOLERTINIB) and recombinant human endostatin (ENDOSTAR). In the retrospective part, we will extract the existing data of patients treated with AUMOLERTINIB alone from the hospital\'s electronic medical record system as a control group. The primary endpoint is progression free survival (PFS). Secondary endpoints are objective response rate (ORR), duration of response (DoR), adverse events (AE), quality of life (EORTCQLQ-L13) score, anxiety and depression self-rating scale (HADS) and patient health questionnaire-9 (PHQ-9).

Route:

In the prospective part, we will perform genetic testing on patients to determine their EGFR mutation status. Then, we will treat patients with stage IIIB-IV NSCLC with EGFR amino acid 21 L858R mutation and amino acid 19 deletion with ametinib mesylate and recombinant human endostatin, and match the corresponding data in the hospital database. We will regularly follow up patients participating in the prospective study, collect data on their disease progression and survival, and perform statistical analysis on these data to evaluate the effectiveness and safety of the combination therapy.

Expected:

We expect that the combination of ametinib mesylate and recombinant human endostatin can improve the survival rate and quality of life of patients with stage IIIB-IV NSCLC with EGFR amino acid 21 L858R mutation and amino acid 19 deletion. This is mainly because ametinib mesylate and recombinant human endostatin target EGFR hyperactivity and angiogenesis, two processes that play a key role in the development of NSCLC, respectively, so their combined use may produce a synergistic effect, thereby improving the therapeutic effect.

03

Conditions studied

  • Non-Small Cell Lung Cancer

Keywords

  • Endostar
  • Almonertinib
  • Pathologically confirmed stage III-IV NSCLC
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with stage IIIB-IV NSCLC carrying EGFRL858R mutation and 19th amino acid deletion (19del).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • confirmed stage IIIB-IV non-small cell lung cancer (NSCLC).
  • Documented EGFR exon 19 deletion (19del) or exon 21 L858R mutation.
  • Aged 18 years or older.
  • (ECOG) performance status of 0-2.
  • of more than 3 months.
  • Willing and able to comply with the study protocol.

Exclusion criteria

Exclusion Criteria:

  • Known to aumolertinib, recombinant human endostatin (Endostar), or other EGFR tyrosine kinase inhibitors (EGFR-TKIs).
  • Other malignant tumors, except basal cell carcinoma and carcinoma in situ.
  • Use of strong inhibitors or inducers, or CYP substrates (e.g., CYP2C8, CYP2D6), within 7 days before the first dose of study drug.
  • Serious comorbidities or other medical conditions that may affect drug safety or study results, such as severe heart disease (including a documented history of congestive heart failure, high-risk uncontrolled arrhythmia, angina pectoris requiring medication, clinically diagnosed valvular heart disease, electrocardiographic evidence of prior severe myocardial infarction, and hypertension), severe liver disease, or kidney disease.
  • Other anti-tumor treatment within the past 30 days, including but not limited to surgery, radiotherapy, chemotherapy, and immunotherapy (except concurrent radiotherapy for non-target lesions).
  • (ALT) or aspartate aminotransferase (AST) >3× the (ULN) in patients without liver , or >5×ULN in patients with liver metastases.
  • Serum creatinine >1.5×ULN and \<50 mL/min (Cockcroft-Gault formula); creatinine clearance needs to be confirmed only when serum creatinine >1.5×ULN.
  • (LVEF) \<50%.
  • Abnormal coagulation ( >1.5×ULN or INR >1.5); current thrombolytic, anticoagulant, or antiplatelet therapy; or bleeding tendency or active bleeding (e.g., hemoptysis or gastrointestinal bleeding).
  • Arterial or venous thrombotic events, such as cerebrovascular accident (including ), deep vein thrombosis, or pulmonary embolism, within 6 months before enrollment.
  • History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring treatment, or any evidence of clinically active interstitial lung disease.
  • Pregnant or lactating women.
  • Any other condition that, in the investigator's judgment, makes the patient unsuitable for the study.
Terms in these criteria, in plain language(14)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1 participant (actual)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • prospective part

    For the prospective part, we will treat newly enrolled patients with the combination of Almonertinib and Endostar.

  • retrospective part

    we will extract the data of patients who previously used Almonertinib alone from the hospital database as the control group.

06

What researchers measure

Primary outcomes

  1. progression-free survival (PFS)

    Refers to the time from the start of a randomized clinical trial to tumor progression (in any aspect) or death from any cause.

    Time frame: 3 months

Secondary outcomes

  1. objective response rate

    Refers to the proportion of patients whose tumors shrink or stabilize for a certain period of time, including cases of complete remission (CR), partial remission (PR) and stable disease (SD)

    Time frame: 3 months

  2. Adverse events

    Adverse medical events that occur after a clinical trial participant receives a drug

    Time frame: 3 months

  3. Global Health Status/Quality of Life Measured by EORTC QLQ-C30

    Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The global health status/quality of life (GHS/QoL) scale score ranges from 0 to 100; higher scores indicate better quality of life.

    Time frame: 3 months

  4. Depressive Symptoms Measured by Patient Health Questionnaire-9 (PHQ-9)

    Assessed using the Patient Health Questionnaire-9 (PHQ-9). The total score ranges from 0 to 27; higher scores indicate more severe depressive symptoms.

    Time frame: 3 months

  5. Anxiety Symptoms Measured by HADS Anxiety Subscale (HADS-A)

    Assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The subscale score ranges from 0 to 21; higher scores indicate more severe anxiety symptoms.

    Time frame: 3 months

  6. Depressive Symptoms Measured by HADS Depression Subscale (HADS-D)

    Assessed using the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). The subscale score ranges from 0 to 21; higher scores indicate more severe depressive symptoms.

    Time frame: 3 months

  7. Duration of Remission

    refers to the time from the first assessment of CR or PR to the first assessment of PD or death from any cause.

    Time frame: 3 months

07

Study locations

1 site
  • chongqing University Three Gorges Hospital
    Chongqing, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2024 to primary completion in Jul 2026, 30 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 25, 2024
First posted
Oct 27, 2026
StartActual
Jan 1, 2024
Primary completionActual
Jul 10, 2026
CompletionActual
Jul 10, 2026
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07897019
Lead sponsor
Three Gorges Hospital of Chongqing University
Responsible party
Sponsor
First posted
Oct 27, 2026
Start date
Jan 1, 2024
Primary completion
Jul 10, 2026
Completion
Jul 10, 2026
Last update
Oct 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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