Non-Small-Cell LungNCT03766490
Anlotinib Hydrochloride Combined With EGFR TKIs in Advanced Non-small Cell Lung Cancer
A study testing Anlotinib Hydrochloride, Gefitinib and Icotinib in people with Non-Small-Cell Lung, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
After the second-line treatment of patients with non-T790M mutations, chemotherapy with platinum-containing drugs was used, and chemotherapy-related toxicity was high. Studies have shown that bevacizumab combined with EGFR TKI have a good trend of benefit. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small-Cell Lung
- What is being tested?
- Anlotinib Hydrochloride, Gefitinib and Icotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2019to 20 Dec 2020
- 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
- Participants must have histlogically confirmed stage IV non-small cell lung cancer .
- The initial treatment with gefitinib/icotinib evaluated PR/NC and the efficacy lasted for more than 6 months, then the disease progressed later. (The efficacy was assessed as PD according to the evaluation standard of RECIST1.1)
- At least a measurable lesion that meets the RECIST 1.1 criteria.
- Any gender. Age ≥18 years and ≤75 years
- Life expectancy >3 months.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
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- Previously, EGFR gene test showed EGFR exon 19 deletion or exon 21 (L858R) mutation, and the gene test showed no T790M mutation before enrollment.
- Adequate organ function: haemoglobin ≥ 90 g/L;neutrophils count ≥1.5×109/L; platelet count ≥ 90 × 109/L; total bilirubin ≤ 1.5 × ULN ;ALT < 2 × ULN, (ALT < 5 × ULN, for those with liver metastases);AST < 2 × ULN, (AST < 5 × ULN, for those with liver metastases); Cr≤1.5× ULN.
- Echocardiography : LVEF≥50%
- 12-leads electrocardiogram : QTcF<450ms (man), <470ms(woman)
- Patient informed consent and signed written consent
- Patient compliance was good and voluntary follow-up, treatment, laboratory testing, and other research steps were performed as planned.
Who cannot join
- The patient has previously received anti-tumor therapy for EGFR TKIs other than gefitinib and ectinib for lung cancer.
- Patients that cannot detect EGFR gene, or patients with known T790M mutation.
- Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer).
- CT or MRI shows that the tumor lesion is ≤ 5 mm from the large vessel, or there is a central tumor that invades the local large blood vessel; or there is a significant pulmonary cavity or necrotizing tumor.
- Active brain metastasis, cancerous meningitis, spinal cord compression patients.
- Other active malignancies that require simultaneous treatment.
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- Has a history of malignant tumors in the past 5 years.
- Patients with previous anti-tumor treatment-related adverse reactions who have not recovered to NCI-CTC AE≤1.
- Abnormal coagulation ,with bleeding tendency or undergoing thrombolysis or anticoagulant therapy.
- Renal insufficiency: urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0g, or creatinine clearance <60ml / min.
- Severe acute or chronic infection requiring systemic treatment.
- Suffering from severe cardiovascular disease: myocardial ischemia ,myocardial or arrhythmia.
- Clinically significant hemoptysis occurred within 3 months prior to enrollment; or significant clinically significant bleeding symptoms or a clear tendency to hemorrhage.
- Untreated active hepatitis : Hepatitis B or Hepatitis C
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated hospital of soochow university
Suzhou, Jangsu
Min Tao, Doctor
About this study
Official title: A Prospective, Single-arm, Multicenter Study of Anlotinib Hydrochloride Combined With First-generation EGFR TKIs as Second-line Treatment in Acquired (Non-T790M Mutation) Resistance Advanced Non-small Cell Lung Cancer
After the second-line treatment of patients with non-T790M mutations, chemotherapy with platinum-containing drugs was used, and chemotherapy-related toxicity was high. Studies have shown that bevacizumab combined with EGFR TKI have a good trend of benefit. This study is aimed to evaluate the efficacy and safety of Anlotinib Hydrochloride combined with first-generation EGFR TKIs as second-line treatment in advanced non-small cell lung cancer . The patients with IV non-small lung cancer have acquired resistance to prior first-generation EGFR TKIs and have non-T790M mutation.
- Conditions
- Non-Small-Cell Lung
- Being tested
- Anlotinib Hydrochloride, Gefitinib, Icotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib HydrochlorideDrug
Capsule, P.O. 12mg qd ,days 1-14, 21 days a cycle
GefitinibDrug
Tablet, P.O. 250mg qd
IcotinibDrug
Tablet, P.O. 125mg tid
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib Hydrochloride plus gefitinib or icotinib | Experimental | Not described Receives: Drug: Anlotinib Hydrochloride; Drug: Gefitinib; Drug: Icotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS（Progress free survival）
PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
Measured: each 42 days up to PD or death(up to 24 months)
Secondary outcomes (4)
Overall Survival (OS)
OS is defined as the time until death due to any cause.
Measured: From randomization until death (up to 24 months)
Objective Response Rate (ORR)
ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.prior to progression or any further therapy.
Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Quality of Life(QoL)
use EORTC QLQ-C30(version 3) questionnaire to evaluate the quality of life.
Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate (DCR)
Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
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 posted6 Dec 2018
- Study start30 Mar 2019 (estimated)
- Primary completion20 Dec 2019 (estimated)
- Study completion20 Dec 2020 (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 LungStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Anlotinib Hydrochloride Combined With gefitinib or Icotinib
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First People's Hospital of Changzhou, Second Affiliated Hospital of Soochow University, Nantong University, Affiliated Hospital of Jiangnan University, Jiangyin People's Hospital, Changzhou No.2 People's Hospital, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Min Tao, Doctor, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766490
- Sponsor's protocol ID
- ALTER-L010
- Status last verified
- Dec 2018
- First submitted
- 2 Dec 2018
- Last updated
- 30 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multicenter Study of Anlotinib Hydrochloride Combined With First-generation EGFR TKIs as Second-line Treatment in Acquired (Non-T790M Mutation) Resistance Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03766490
- Acronym / sponsor ID
- ALTER-L010
- Conditions
- Non-Small-Cell Lung
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- The First People's Hospital of Changzhou, Second Affiliated Hospital of Soochow University, Nantong University, Affiliated Hospital of Jiangnan University, Jiangyin People's Hospital, Changzhou No.2 People's Hospital, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 30 Mar 2019 (estimated)
- Primary completion
- 20 Dec 2019 (estimated)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 6 Dec 2018 (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.
After the second-line treatment of patients with non-T790M mutations, chemotherapy with platinum-containing drugs was used, and chemotherapy-related toxicity was high. Studies have shown that bevacizumab combined with EGFR TKI have a good trend of benefit. This study is aimed to evaluate the efficacy and safety of Anlotinib Hydrochloride combined with first-generation EGFR TKIs as second-line treatment in advanced non-small cell lung cancer . The patients with IV non-small lung cancer have acquired resistance to prior first-generation EGFR TKIs and have non-T790M mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Anlotinib Hydrochloride Combined With gefitinib or Icotinib
| Arm | Type | Receives |
|---|---|---|
| Anlotinib Hydrochloride plus gefitinib or icotinib | Experimental | Drug: Anlotinib Hydrochloride, Drug: Gefitinib, Drug: Icotinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants must have histlogically confirmed stage IV non-small cell lung cancer .
- The initial treatment with gefitinib/icotinib evaluated PR/NC and the efficacy lasted for more than 6 months, then the disease progressed later. (The efficacy was assessed as PD according to the evaluation standard of RECIST1.1)
- At least a measurable lesion that meets the RECIST 1.1 criteria.
- Any gender. Age ≥18 years and ≤75 years
- Life expectancy >3 months.
Key exclusion criteria (14 listed)
- The patient has previously received anti-tumor therapy for EGFR TKIs other than gefitinib and ectinib for lung cancer.
- Patients that cannot detect EGFR gene, or patients with known T790M mutation.
- Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer).
- CT or MRI shows that the tumor lesion is ≤ 5 mm from the large vessel, or there is a central tumor that invades the local large blood vessel; or there is a significant pulmonary cavity or necrotizing tumor.
- Active brain metastasis, cancerous meningitis, spinal cord compression patients.
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 HydrochlorideCapsule, P.O. 12mg qd ,days 1-14, 21 days a cycle | Drug | Anlotinib Hydrochloride plus gefitinib or icotinib |
| GefitinibTablet, P.O. 250mg qd | Drug | Anlotinib Hydrochloride plus gefitinib or icotinib |
| IcotinibTablet, P.O. 125mg tid | Drug | Anlotinib Hydrochloride plus gefitinib or icotinib |
Primary outcome
PFS（Progress free survival）
Time frame: each 42 days up to PD or death(up to 24 months)
PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
4 secondary outcomes
Overall Survival (OS)
Time frame: From randomization until death (up to 24 months)
Objective Response Rate (ORR)
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Quality of Life(QoL)
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Disease Control Rate (DCR)
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 30 Jan 2019.
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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.
Min Tao, Doctor principal investigator
The First Affiliated Hospital of Soochow University
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, Gefitinib and Icotinib in people with Non-Small-Cell Lung, run by The First Affiliated Hospital of Soochow University 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 12 inclusion and 14 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 30 Jan 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 Min Tao, Doctor (008613962125300, taomin@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS（Progress free survival） (time frame: each 42 days up to PD or death(up to 24 months)). 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 30 Jan 2019.