NSCLCNCT04007835

Anlotinib Hydrochloride Combined With EGFR-Tyrosine Kinase Inhibitor (TKI) in Treating Advanced NSCLC Patients With Acquired Resistance to EGFR-TKI

A study testing Anlotinib Hydrochloride in people with NSCLC, run by Guangdong Association of Clinical Trials at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Search all trials

Trial summary

The Single-arm, multicenter study evaluate the safety and efficacy of Anlotinib Hydrochloride combined with EGFR TKIs in treating Advanced NSCLC With acquired Resistance to EGFR TKIs Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: NSCLC
What is being tested?: Anlotinib Hydrochloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteChina
Study dates: Jul 2019to Dec 2021
Phase: Interventional
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

Patients voluntarily participate in this study, signed and dated informed consent with good compliance and follow-up;
Males or females aged 18 Years to 75 Years
The patients should be confirmed with EGFR mutation [e.g., T 790 M , exon 19 deletion, L 858 R, etc],
Cytologically or histologically confirmed locally advanced and / or metastatic non-small cell lung cancer (NSCLC).
Patients should be using the EGFR TKI monotherapy as the first line treatment and meet the following criteria:
Patients who showed objective clinical benefit from treatment with an EGFR

Show all 20Show fewer

TKI as defined by either:
Patients who showed complete (CR) or partial response (PR) ≥ 4 months, or
Patients who maintained stable disease (SD) status ≥ 6 months
Patients who showed 1. risk of recurrence and progression, 2. gradual progression or local progression while on continuous treatment with EGFR TKI within the last 28 days prior to enrollment.( For recurrent diseases, patients can be accepted with adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant chemotherapy in the past, and 3. relapse occurs 6 months after the end of treatment).
CEA≥10ng/ml；
Gradual progression: Disease control lasting ≥6 months with EGFR-TKI treatment, Compared with the previous assessment, no significant increment of tumor burden and progressive involvement of non-target lesions with a score less than 2, and Symptom scored ≤1. Local progression: Disease control lasting more than 3 months with EGFR-TKI treatment, Progressive disease (PD) due to solitary extracranial lesion or limitation in intracranial lesions (covered by a radiation field),and symptom scored ≤1
Evidence of imaging or clinical progression is required if progression of disease occurs during the treatment or after the last treatment.
At least one measurable lesion meet the requirements of the standard Response Evaluation Criteria In Solid Tumors（RESCIST）version 1.1
Life expectancy is at least 3 months;
Eastern Cooperative Oncology Group（ECOG）Performance Status（PS）:0-2.;
The main organs function meet following criteria:
Blood routine examination criteria (no blood transfusion and blood products within 14 days, no correction by Granulocyte Colony-Stimulating Factor (G-CSF) and other hematopoietic stimuli): i) hemoglobin (HB) ≥90g/L ii) Absolute neutrophils count (ANC) ≥1.5×109/L iii) platelet (PLT) ≥80×109/L
Biochemical tests meet the following criteria i) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); ii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5 ULN, if liver metastasis occurred, ALT and AST ≤5 ULN; iii) serum creatinine (Cr) ≤1.25 ULN or creatinine clearance (CCr)≥45 mL/min
Female patients of childbearing age agree that contraceptive measures must be used within the study period and within 8 weeks after the end of the study drug treatment. The serum or urine test indicates nonpregnant woman within 7 days prior to the study. Male patients agree to have contraceptive use during the study period and within 8 weeks after the end of the study period or have had surgical sterilization.

Who cannot join

Small cell lung cancer (including Small cell lung cancer mixed with non-small cell lung cancer);
Imaging (CT or MRI) showed that the distance between the lesion and the large vessels was less than 5 mm, or there were central tumors invading the local large vessels, or there were obvious pulmonary cavity or necrotic tumors.
Patients with active brain metastasis, cancerous meningitis, spinal cord compression, or with brain or pia mater diseases detected by CT or MRI at screening time (patients with stable symptoms and complete treatment 14 days before enrollment may be admitted to the group, but no symptoms of cerebral hemorrhage should be confirmed by craniocerebral MRI, CT or venography evaluation).
Uncontrollable hypertension (systolic blood pressure ≥ 140 mmHg, or diastolic blood pressure ≥ 90 mmHg, despite using the optimal medical treatment;
Patients are participating in other clinical studies, or there are less than four weeks before the end of the previous clinical study.
Other active malignant tumors requiring concurrent treatment;

Show all 23Show fewer

The patient has a history of malignant tumors. Patients with basal cell carcinoma of skin, superficial bladder cancer, squamous cell carcinoma of skin or carcinoma of cervix in situ who had undergone possible curative treatment and had no disease recurrence within 5 years after the initiation of curative treatment are permitted.
Patients had treatment related adverse reactions after previous systemic anti-tumour therapy (except hair loss), but did not recover to NCI-CTCAE ≤ 1 grade.
The patient has the coagulation disorders (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or activated partial thromboplastin time (APTT) > 1.5 ULN), or bleeding tendency, or undergoing thrombolysis or anticoagulation therapy; Note: On the premise that the International Standardized Ratio of Prothrombin Time (INR) is less than 1.5, low doses of heparin (0.6 million to 12,000 U per day for adults) or aspirin (less than 100 mg per day) are allowed for preventive purposes.
Renal insufficiency: Urinary routine indicated that urinary protein ≥ ++ or confirmed 24-hour urinary protein ≥ 1.0 g;
Subjects who had undergone major surgery or had severe trauma had less than 14 days before enrollment.
Severe acute or chronic infections requiring systemic treatment
Severe cardiovascular diseases: grade II or above myocardial ischemia or myocardial infarction and poor control arrhythmias (including corrected QT interval (QTc) interval ≥ 450 ms for males and ≥ 470 ms for females); cardiac insufficiency of grade III to IV according to New York Heart Association (NYHA) criteria, or left ventricular ejection fraction (LVEF) < 50% by color Doppler echocardiography;
≥ CTCAE grade 2 peripheral neuropathy, except for trauma.
Respiratory syndrome (≥ CTCAE grade 2 dyspnea), serous effusion (including pleural effusion, ascites, pericardial effusion) requiring surgical treatment;
Long-term unhealed wound or fracture;
Decompensated diabetes mellitus or other contraindications of high-dose glucocorticoid therapy;
There are obvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction;
Three months prior to enrollment, significant hemoptysis (more than 50 ml per day) occurred, or significant clinical hemorrhage symptoms or defined bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ or above, or suffering from vasculitis.
Arteriovenous thrombosis events occurred within 12 months before enrollment, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism.
Patients participated in clinical trials of other antineoplastic drugs within four weeks prior to enrollment, or planned systemic anti-tumor therapy within four weeks prior to enrollment or during the period of the study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or use of mitomycin C within six weeks prior to the treatment of the experimental drugs). Over-extended-field radiotherapy (EF-RT) was performed within four weeks prior to grouping or limited-field radiotherapy to evaluate the tumor lesions was performed within two weeks prior to grouping;
Physical and laboratory findings Untreated active hepatitis (hepatitis B: HBsAg positive and hepatitis B virus (HBV) DNA ≥ 500 IU/mL; hepatitis C: hepatitis C virus (HCV) RNA positive and abnormal liver function); co-infection of hepatitis B and hepatitis C;
According to the researcher's judgment, patients may have other factors that may lead to the forced termination of the study, such as other serious diseases or serious abnormal laboratory examinations or other factors that may affect the safety of the subjects, or family or social factors such as test data and sample collection.

Trial locations and contacts

1 site in 1 country.

HUAJUN CHEN, MD contact

0086-13710581145

chjdoctor@163.com

China1 site

Guangdong General Hospital
Guangzhou, Guangdong, 510080
HUAJUN CHEN, MD
HUAJUN CHEN, MD

Other trials in China

About this study

Official title: Safety and Efficacy of Anlotinib Hydrochloride Combined With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR TKIs) in Treating Advanced Non-small-cell Lung Cancer (NSCLC) Patients With Acquired Resistance to EGFR TKIs

The Single-arm, multicenter study evaluate the safety and efficacy of Anlotinib Hydrochloride combined with EGFR TKIs in treating Advanced NSCLC With acquired Resistance to EGFR TKIs

Read the detailed description

EGFR TKI have been approved as first-line treatment in NSCLC patients harboring EGFR mutation. However, the acquired resistance of EGFR-TKI occurs almost constantly. Anlotinib is a novel oral multitarget tyrosine kinase inhibitor and primary targeted to Vascular Endothelial Growth Factor Receptor (VEGFR), fibroblast growth factor receptor (FGFR) , platelet-derived growth factor receptor (PDGFR) and c-Kit. The ALTER-0303 trial showed that patients with advanced non-small cell lung cancer (NSCLC) who received anlotinib as third-line or further therapy had more survival benefit. The Single-arm, multicenter study evaluate the safety and efficacy of Anlotinib Hydrochloride combined with EGFR TKIs in treating Advanced NSCLC With acquired Resistance to EGFR TKIs

Conditions: NSCLC
Being tested: Anlotinib Hydrochloride

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anlotinib HydrochlorideDrug
Also called Gefitinib Tablets, Erlotinib Hydrochloride Tablets, Icotinib Hydrochloride Tablets
anlotinib (12 mg orally daily for 14 days every 21 days cycle) combined with one of EGFR-TKIs

Study groups in NCT04007835
Study group	Role	What they receive
Anlotinib Hydrochloride combined with EGFR-TKI	Experimental	Patients receive anlotinib (12 mg orally daily for 14 days every 21 days cycle) combined with one of following EGFR-TKIs: Gefitinib is administered 250 mg once per day. Erlotinib is administered 150 mg once per day , or Icotinib is administered 125 mg three times per day, until disease progression or untolerated toxicity. Receives: Drug: Anlotinib Hydrochloride

What is being measured

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

Progression free survival（PFS）
Measured: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs earlier, assessed up to 1 year

Secondary outcomes (7)

6 months and 12 months progression-free survival (PFS) Rate
Measured: Up to 1 year
objective response rate (ORR)
Measured: Up to 1 year
Disease Control Rate(DCR)
Measured: Up to 1 year
Overall survival (OS)
Measured: From the date of randomization to the date of death from any cause，assessed up to 2 year
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Adverse Events
Measured: Up to 21 days post-the last treatment
progression-free survival (PFS) for different types of EGFR mutation
Measured: Up to 1 year
Overall survival (OS) for different types of EGFR mutation
Measured: Up to 2 year

Timeline

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

Jul 2019Dec 2021

First posted5 Jul 2019
Study startJul 2019 (estimated)
Primary completionJul 2021 (estimated)
Study completionDec 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for NSCLCStudies 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04007835
Sponsor's protocol ID: CTONG1803
Status last verified: Jul 2019
First submitted: 25 Jun 2019
Last updated: 5 Jul 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Chen HJ, Tu HY, Hu Y, Fan Y, Wu G, Cang S, Yang Y, Yang N, Ma R, Jin G, Xu X, Liu A, Tang S, Cheng Y, Yu Y, Xu CR, Zhou Q, Wu YL. A phase II trial of anlotinib plus EGFR-TKIs in advanced non-small cell lung cancer with gradual, oligo, or potential progression after EGFR-TKIs treatment (CTONG-1803/ALTER-L001). J Hematol Oncol. 2025 Jan 5;18(1):3. doi: 10.1186/s13045-024-01656-0.
PubMed 39757186

Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Anlotinib Hydrochloride Combined With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR TKIs) in Treating Advanced Non-small-cell Lung Cancer (NSCLC) Patients With Acquired Resistance to EGFR TKIs
ClinicalTrials.gov ID: NCT04007835
Acronym / sponsor ID: CTONG1803
Conditions: NSCLC
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 120 participants (estimated)
Lead sponsor: Guangdong Association of Clinical TrialsUniversity, hospital or other
Collaborators: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study start: Jul 2019 (estimated)
Primary completion: Jul 2021 (estimated)
Study completion: Dec 2021 (estimated)
First posted: 5 Jul 2019 (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.

The Single-arm, multicenter study evaluate the safety and efficacy of Anlotinib Hydrochloride combined with EGFR TKIs in treating Advanced NSCLC With acquired Resistance to EGFR TKIs

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Anlotinib Hydrochloride combined with EGFR-TKI	Experimental	Drug: Anlotinib HydrochloridePatients receive anlotinib (12 mg orally daily for 14 days every 21 days cycle) combined with one of following EGFR-TKIs: Gefitinib is administered 250 mg once per day. Erlotinib is administered 150 mg once per day , or Icotinib is administered 125 mg three times per day, until disease progression or untolerated toxicity.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

Patients voluntarily participate in this study, signed and dated informed consent with good compliance and follow-up;
Males or females aged 18 Years to 75 Years
The patients should be confirmed with EGFR mutation [e.g., T 790 M , exon 19 deletion, L 858 R, etc],
Cytologically or histologically confirmed locally advanced and / or metastatic non-small cell lung cancer (NSCLC).
Patients should be using the EGFR TKI monotherapy as the first line treatment and meet the following criteria:

Key exclusion criteria (23 listed)

Small cell lung cancer (including Small cell lung cancer mixed with non-small cell lung cancer);
Imaging (CT or MRI) showed that the distance between the lesion and the large vessels was less than 5 mm, or there were central tumors invading the local large vessels, or there were obvious pulmonary cavity or necrotic tumors.
Patients with active brain metastasis, cancerous meningitis, spinal cord compression, or with brain or pia mater diseases detected by CT or MRI at screening time (patients with stable symptoms and complete treatment 14 days before enrollment may be admitted to the group, but no symptoms of cerebral hemorrhage should be confirmed by craniocerebral MRI, CT or venography evaluation).
Uncontrollable hypertension (systolic blood pressure ≥ 140 mmHg, or diastolic blood pressure ≥ 90 mmHg, despite using the optimal medical treatment;
Patients are participating in other clinical studies, or there are less than four weeks before the end of the previous clinical 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
Anlotinib HydrochlorideAlso: Gefitinib Tablets, Erlotinib Hydrochloride Tablets, Icotinib Hydrochloride Tabletsanlotinib (12 mg orally daily for 14 days every 21 days cycle) combined with one of EGFR-TKIs	Drug	Anlotinib Hydrochloride combined with EGFR-TKI

Primary outcome

Progression free survival（PFS）
Time frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs earlier, assessed up to 1 year

7 secondary outcomes

6 months and 12 months progression-free survival (PFS) Rate
Time frame: Up to 1 year
objective response rate (ORR)
Time frame: Up to 1 year
Disease Control Rate(DCR)
Time frame: Up to 1 year
Overall survival (OS)
Time frame: From the date of randomization to the date of death from any cause，assessed up to 2 year
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 21 days post-the last treatment
progression-free survival (PFS) for different types of EGFR mutation
Time frame: Up to 1 year
Overall survival (OS) for different types of EGFR mutation
Time frame: Up to 2 year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
Derived from this study: PubMed 39757186Chen HJ, Tu HY, Hu Y, Fan Y, Wu G, Cang S, Yang Y, Yang N, Ma R, Jin G, Xu X, Liu A, Tang S, Cheng Y, Yu Y, Xu CR, Zhou Q, Wu YL. A phase II trial of anlotinib plus EGFR-TKIs in advanced non-small cell lung cancer with gradual, oligo, or potential progression after EGFR-TKIs treatment (CTONG-1803/ALTER-L001). J Hematol Oncol. 2025 Jan 5;18(1):3. doi: 10.1186/s13045-024-01656-0.

Related trials for NSCLC

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

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.

HUAJUN CHEN, MD contact

0086-13710581145

chjdoctor@163.com

Yi-Long Wu, MD study chair

Guangdong General Hospital (GGH)& Guangdong Academy of Medical Sciences

HUAJUN CHEN, MD study director

Guangdong Provincial People's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Anlotinib Hydrochloride in people with NSCLC, run by Guangdong Association of Clinical Trials 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 20 inclusion and 23 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 5 Jul 2019. 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.

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 HUAJUN CHEN, MD (0086-13710581145, chjdoctor@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（PFS） (time frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs earlier, assessed up to 1 year). 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 NCT04007835, which also lists 1 linked publication.

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 5 Jul 2019.