Non Small Cell Lung CancerPhase 3SAINTNCT04797806
Study of Anlotinib Combined With Icotinib as the First-line Treatment in Patients With EGFR Concomitant Mutation NSCLC
A Phase 3 study testing Anlotinib and Icotinib in people with Non Small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Evaluate the efficacy and safety of Anlotinib plus Icotinib as the first-line treatment in patients with sensitive EGFR concomitant mutations advanced non-small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Anlotinib and Icotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2021to 30 Apr 2023
- Phase
- Phase 3
- 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
- Signed and dated informed consent 18-75years，ECOG PS：0-2，Life expectancy of more than 3 months，with measurable lesion ( RECIST1.1) Histologically or cytologically confirmed, locally advanced and/or metastatic IIIB, IIIC or IV non-squamous NSCLC or recurrent non-squamous NSCLC（according to the 8th Edition of the AJCC Staging system）with EGFR 19 del or 21 L858R gene mutation and concomitant others.
- Has not received chemotherapy or other targeted therapies；For recurrent disease, adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant chemotherapy may be accepted, but recurrence occurs after ≥6 months from stopping treatment.
- ≥1 target lesion that has not received radiotherapy in the past 3 months and can be accurately measured in at least 1 direction；Previously received radiation therapy, but the radiotherapy area must be <25% of the bone marrow area, and radiation therapy must have closed for at least≥4 weeks at the time of enrollment; Main organs function is normal Patients of brain metastases with asymptomatic or mild symptoms can be enrolled The woman patients of childbearing age must agree to take contraceptive methods during the research and within another 8 weeks after treatment. Pregnancy test (blood serum test or urine) should be done within 7 days before the research and the result should be negative.The man patients who must agree to take contraceptive methods during the research and within another 8 weeks after treatment.
Who cannot join
- Squamous cell carcinoma (including adenosquamous carcinoma); Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer) ALK-positive NSCLC Central Lung tumors that Imaging (CT or MRI) shows tumor lesions invade local large blood vessels; or with significant pulmonary cavum or necrotizing Patients with obvious brain metastases, cancerous meningitis, spinal cord compression, or with brain or pia mater disease. (patient with brain metastases who have completed treatment 14 days before and the symptoms are stable can be Enrolled, also should have no cerebral hemorrhage symptoms confirmed by brain MRI, CT or venography evaluation The patient is participating in other clinical studies or Participated in other anti-tumor drug clinical trials within 4 weeks before enrollment With other active malignancies that require simultaneous treatment Has a history of malignant tumors. Except for patients with cutaneous basal cell carcinoma, superficial bladder cancer, cutaneous squamous cell carcinoma or orthotopic cervical cancer who have undergone curative treatment and have no disease recurrence within 5 years after the start of treatment Patients with adverse reactions derived from previous therapies (excluding hair loss), which is over level 1 in CTC AE (5.0) abnormal blood coagulation (INR>1.5 or PT > ULN + 4s or APTT > 1.5 ULN), with bleeding tendency or receiving thrombolytic or anticoagulant therapy renal insufficiency: urinary protein ≥ ++, or 24-hour urine protein ≥ 1.0g; The effect of surgery or trauma has been eliminated for less than 14 days before enrollment Severe acute or chronic infections requiring systemic treatment Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias Patients with peripheral neuropathy which is over level 2 in CTC AE (5.0), except for trauma respiratory syndrome (dyspnea≥CTC AE 2), severe pleural effusion, ascites, pericardial effusion Long-term unhealed wounds or fractures Decompensated diabetes or other ailments treated with high doses of glucocorticoids with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus) hemoptysis (daily hemoptysis>50ml) within 3 months prior to enrollment; or significant clinically significant bleeding symptoms or defined bleeding tendency Thrombosis events occurring within 12 months prior to enrollment Planned to get systemic anti-tumor therapy during this study；EF-RT was performed within 4 weeks before enrollment or limited field radiotherapy within 2 weeks before grouping Hypertension (systolic blood pressure≥140 mmHg or diastolic blood pressure≥90 mmHg) that is still uncontrollable using two or more combination therapies History of psychotropic substance abuse and inability to quit or have mental disorders HIV test positive history or AIDS; untreated active hepatitis; combined with hepatitis B and hepatitis C co-infection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Dingzhi Huang, M.D., +86-22-23340123-1031, dingzhih72@163.com
Dingzhi Huang, M.D.
About this study
Official title: Phase III Study Comparing Anlotinib Plus Icotinib to Icotinib in Patients With Untreated Non-squmous NSCLC Harboring EGFR Concomitant Mutations
Evaluate the efficacy and safety of Anlotinib plus Icotinib as the first-line treatment in patients with sensitive EGFR concomitant mutations advanced non-small cell lung cancer
Read the detailed description
Anlotinib Hydrochloride is a kind of innovative medicines approved by State Food and Drug Administration（CFDA:2011L00661） which was developed by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Anlotinib, Icotinib
- Keywords
- sensitive EGFR mutations and concomitant orthers, anlotinib, icotinib, first line, non-squamous 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.
AnlotinibDrug
Anlotinib 12 mg once a day from day 1 to 14 of a 21-day cycle.
IcotinibDrug
Icotinib：125 mg/tablet，three times a day，fasting or serving with food. It should be continued until disease progression or intolerable toxicity or patients withdraw of consent.
| Study group | Role | What they receive |
|---|---|---|
| combination therapy | Experimental | Anlotinib Combined With Icotinib Receives: Drug: Anlotinib; Drug: Icotinib |
| monotherapy | Other | Icotinib Receives: Drug: Icotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS（Progress free survival）
The PFS time is defined as time from enrollment to locoregional or systemic recurrence, second malignancy or death due to any cause; censored observations will be the last date of : "death", "last tumor assessment", "last follow up date" or "last date in drug log"
Measured: each 42 days up to PD or death (up to 24 months)
Secondary outcomes (4)
OS（Overall Survival）
OS was defined as time from date of enrollment to date of death due to any cause. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive.
Measured: From enrollment until death (up to 24 months)]
ORR（Objective Response Rate）
To evaluate the effectiveness of Anlotinib Hydrochloric Capsule Plus Icotinib Hydrochloric Tablet by enhanced CT/MRI scan every two cycles. Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients.
Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)]
DCR（Disease Control Rate）
To evaluate the effectiveness of Anlotinib Hydrochloric Capsule Plus Icotinib Hydrochloric Tablet by enhanced CT/MRI scan every two cycles. Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease).
Measured: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Adverse Events
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Until 30 day safety follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start12 Mar 2021 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2023 (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 Tianjin Medical University Cancer Institute and 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797806
- Sponsor's protocol ID
- SAINT
- Acronym
- SAINT
- Status last verified
- Jan 2021
- First submitted
- 12 Mar 2021
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study Comparing Anlotinib Plus Icotinib to Icotinib in Patients With Untreated Non-squmous NSCLC Harboring EGFR Concomitant Mutations
- ClinicalTrials.gov ID
- NCT04797806
- Acronym / sponsor ID
- SAINT / SAINT
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- sensitive EGFR mutations and concomitant orthers, anlotinib, icotinib, first line, non-squamous NSCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 12 Mar 2021 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 15 Mar 2021 (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.
Evaluate the efficacy and safety of Anlotinib plus Icotinib as the first-line treatment in patients with sensitive EGFR concomitant mutations advanced non-small cell lung cancer
Detailed description
Anlotinib Hydrochloride is a kind of innovative medicines approved by State Food and Drug Administration（CFDA:2011L00661） which was developed by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination therapy | Experimental | Drug: Anlotinib, Drug: IcotinibAnlotinib Combined With Icotinib |
| monotherapy | Other | Drug: IcotinibIcotinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed and dated informed consent 18-75years，ECOG PS：0-2，Life expectancy of more than 3 months，with measurable lesion ( RECIST1.1) Histologically or cytologically confirmed, locally advanced and/or metastatic IIIB, IIIC or IV non-squamous NSCLC or recurrent non-squamous NSCLC（according to the 8th Edition of the AJCC Staging system）with EGFR 19 del or 21 L858R gene mutation and concomitant others.
- Has not received chemotherapy or other targeted therapies；For recurrent disease, adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant chemotherapy may be accepted, but recurrence occurs after ≥6 months from stopping treatment.
- ≥1 target lesion that has not received radiotherapy in the past 3 months and can be accurately measured in at least 1 direction；Previously received radiation therapy, but the radiotherapy area must be <25% of the bone marrow area, and radiation therapy must have closed for at least≥4 weeks at the time of enrollment; Main organs function is normal Patients of brain metastases with asymptomatic or mild symptoms can be enrolled The woman patients of childbearing age must agree to take contraceptive methods during the research and within another 8 weeks after treatment. Pregnancy test (blood serum test or urine) should be done within 7 days before the research and the result should be negative.The man patients who must agree to take contraceptive methods during the research and within another 8 weeks after treatment.
Key exclusion criteria (1 listed)
- Squamous cell carcinoma (including adenosquamous carcinoma); Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer) ALK-positive NSCLC Central Lung tumors that Imaging (CT or MRI) shows tumor lesions invade local large blood vessels; or with significant pulmonary cavum or necrotizing Patients with obvious brain metastases, cancerous meningitis, spinal cord compression, or with brain or pia mater disease. (patient with brain metastases who have completed treatment 14 days before and the symptoms are stable can be Enrolled, also should have no cerebral hemorrhage symptoms confirmed by brain MRI, CT or venography evaluation The patient is participating in other clinical studies or Participated in other anti-tumor drug clinical trials within 4 weeks before enrollment With other active malignancies that require simultaneous treatment Has a history of malignant tumors. Except for patients with cutaneous basal cell carcinoma, superficial bladder cancer, cutaneous squamous cell carcinoma or orthotopic cervical cancer who have undergone curative treatment and have no disease recurrence within 5 years after the start of treatment Patients with adverse reactions derived from previous therapies (excluding hair loss), which is over level 1 in CTC AE (5.0) abnormal blood coagulation (INR>1.5 or PT > ULN + 4s or APTT > 1.5 ULN), with bleeding tendency or receiving thrombolytic or anticoagulant therapy renal insufficiency: urinary protein ≥ ++, or 24-hour urine protein ≥ 1.0g; The effect of surgery or trauma has been eliminated for less than 14 days before enrollment Severe acute or chronic infections requiring systemic treatment Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias Patients with peripheral neuropathy which is over level 2 in CTC AE (5.0), except for trauma respiratory syndrome (dyspnea≥CTC AE 2), severe pleural effusion, ascites, pericardial effusion Long-term unhealed wounds or fractures Decompensated diabetes or other ailments treated with high doses of glucocorticoids with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus) hemoptysis (daily hemoptysis>50ml) within 3 months prior to enrollment; or significant clinically significant bleeding symptoms or defined bleeding tendency Thrombosis events occurring within 12 months prior to enrollment Planned to get systemic anti-tumor therapy during this study；EF-RT was performed within 4 weeks before enrollment or limited field radiotherapy within 2 weeks before grouping Hypertension (systolic blood pressure≥140 mmHg or diastolic blood pressure≥90 mmHg) that is still uncontrollable using two or more combination therapies History of psychotropic substance abuse and inability to quit or have mental disorders HIV test positive history or AIDS; untreated active hepatitis; combined with hepatitis B and hepatitis C co-infection
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 |
|---|---|---|
| AnlotinibAnlotinib 12 mg once a day from day 1 to 14 of a 21-day cycle. | Drug | combination therapy |
| IcotinibIcotinib：125 mg/tablet，three times a day，fasting or serving with food. It should be continued until disease progression or intolerable toxicity or patients withdraw of consent. | Drug | combination therapy, monotherapy |
Primary outcome
PFS（Progress free survival）
Time frame: each 42 days up to PD or death (up to 24 months)
The PFS time is defined as time from enrollment to locoregional or systemic recurrence, second malignancy or death due to any cause; censored observations will be the last date of : "death", "last tumor assessment", "last follow up date" or "last date in drug log"
4 secondary outcomes
OS（Overall Survival）
Time frame: From enrollment until death (up to 24 months)]
ORR（Objective Response Rate）
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)]
DCR（Disease Control Rate）
Time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
Adverse Events
Time frame: Until 30 day safety follow-up visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
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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.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anlotinib and Icotinib in people with Non Small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital 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 3 inclusion and 1 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 15 Mar 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 15 Mar 2021.