Lung CancerPhase 2NCT04671303
To Evaluate the Efficacy and Safety of Anlotinib Combined With Furmonertinib Mesylate in Lung Cancer
A Phase 2 study testing Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate in people with Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate in First-line Treatment of Advanced no-squamous and No-small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 27 Jul 2023
- 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
- Locally advanced and/or metastatic NSCLC diagnosed histologically and/or cytologically;
- Age 18 and above; Eastern Cooperative Oncology Group Physical condition: 0~1; The expected survival time is more than 3 months;
- The previous report confirmed the presence of an EGFR gene exon 19 deletion mutation or exon 21 L858R mutation, and the investigator verified that the report reflects the patient's current genetic status.
- There is at least one measurable lesion other than brain lesion defined by Response Evaluation Criteria In Solid Tumors 1.1 standard;
- The main organs are functioning well,Adequate laboratory indicators.
- Women of childbearing age should agree to use contraceptives during the study period and for a period of six months after the study; Negative serum or urine pregnancy test within 7 days prior to study inclusion, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study period;
- Patients voluntarily participated in this study, signed informed consent, and had good compliance.
Who cannot join
- Prior history of targeted Epidermal Growth Factor Receptor therapy and anti-angiogenic drugs
- Received chemical or biological drugs after the diagnosis of advanced stage;
- Subjects had undergone surgery , radiation therapy or other anticancer therapies within 4 weeks prior to the commencement of study treatment; Subjects who have previously received local radiation therapy may be enrolled if the following conditions are met: more than 4 weeks after the end of radiation therapy ;
- Within 2 weeks before the start of the study, patients were treated with Chinese medicines
- Imaging shows that the tumor has invaded the periphery of important blood vessels or the investigator has determined that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study.
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage ;
- Brain metastases with symptoms or symptom control time less than 2 weeks;
Trial locations and contacts
1 site in 1 country.
China1 site
cancer hospital Chinese academy of medical sciences
Beijing, Beijing Municipality, 100021
About this study
Official title: This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined With Furmonertinib Mesylate in First-line Treatment of Advanced No-small Cell Lung Cancer
This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate in First-line Treatment of Advanced no-squamous and No-small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutation.
Read the detailed description
This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate in First-line Treatment of Advanced No-squamous and No-small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutation.
This study is a single arm, phase II study, including 18 to 36 subjects; Common Terminology Criteria for Adverse Events 5.0 standard was used to evaluate adverse events of drugs, and Response Evaluation Criteria In Solid Tumors 1.1 was used to evaluated efficacy.
- Conditions
- Lung Cancer
- Being tested
- Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib Hydrochloride Capsule Combined with Furmonertinib MesylateDrug
Anlotinib Hydrochloride Capsule: Oral on an empty stomach, once a day, 1 capsule each time, orally for 2 consecutive weeks, stop for 1 week Furmonertinib Mesylate：The dose of Furmonertinib Mesylate is 80 mg once a day, 2 tablets each time, taken orally on an empty stomach before breakfast.
Take medicine continuously for 3 weeks (21 days) for 1 cycle.
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate | Experimental | Anlotinib Hydrochloride Capsule: Oral on an empty stomach, once a day, 1 capsule each time, orally for 2 consecutive weeks, stop for 1 week Furmonertinib Mesylate：The dose of Furmonertinib Mesylate is 80 mg once a day, 2 tablets each time, taken orally on an empty stomach before breakfast.
Take medicine continuously for 3 weeks (21 days) for 1 cycle. Receives: Drug: Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Efficacy of drug therapy
The probability and severity of first cycle adverse events (AE) and serious adverse events (SAE) (based on Common Terminology Criteria for Adverse Events 5.0) and abnormal laboratory test indicators;
Measured: up to 4 weeks
Secondary outcomes (1)
The overall efficacy was assessed by the investigators
Objective response rate (ORR) assessed by the investigators
Measured: up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Jan 2021
- Primary completion30 Jun 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuankai Shi, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Yuankai SHI, Doctor, Principal investigator, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671303
- Sponsor's protocol ID
- ALTN-AFTN-II-01
- Status last verified
- Jul 2020
- First submitted
- 30 Nov 2020
- Last updated
- 11 May 2025
- 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 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined With Furmonertinib Mesylate in First-line Treatment of Advanced No-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04671303
- Acronym / sponsor ID
- ALTN-AFTN-II-01
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 17 Dec 2020 (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.
This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate in First-line Treatment of Advanced no-squamous and No-small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutation.
Detailed description
This Study is To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate in First-line Treatment of Advanced No-squamous and No-small Cell Lung Cancer with Epidermal Growth Factor Receptor Mutation.
This study is a single arm, phase II study, including 18 to 36 subjects; Common Terminology Criteria for Adverse Events 5.0 standard was used to evaluate adverse events of drugs, and Response Evaluation Criteria In Solid Tumors 1.1 was used to evaluated efficacy.
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 Capsule Combined with Furmonertinib Mesylate | Experimental | Drug: Anlotinib Hydrochloride Capsule Combined with Furmonertinib MesylateAnlotinib Hydrochloride Capsule: Oral on an empty stomach, once a day, 1 capsule each time, orally for 2 consecutive weeks, stop for 1 week Furmonertinib Mesylate：The dose of Furmonertinib Mesylate is 80 mg once a day, 2 tablets each time, taken orally on an empty stomach before breakfast. Take medicine continuously for 3 weeks (21 days) for 1 cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Locally advanced and/or metastatic NSCLC diagnosed histologically and/or cytologically;
- Age 18 and above; Eastern Cooperative Oncology Group Physical condition: 0~1; The expected survival time is more than 3 months;
- The previous report confirmed the presence of an EGFR gene exon 19 deletion mutation or exon 21 L858R mutation, and the investigator verified that the report reflects the patient's current genetic status.
- There is at least one measurable lesion other than brain lesion defined by Response Evaluation Criteria In Solid Tumors 1.1 standard;
- The main organs are functioning well,Adequate laboratory indicators.
Key exclusion criteria (7 listed)
- Prior history of targeted Epidermal Growth Factor Receptor therapy and anti-angiogenic drugs
- Received chemical or biological drugs after the diagnosis of advanced stage;
- Subjects had undergone surgery , radiation therapy or other anticancer therapies within 4 weeks prior to the commencement of study treatment; Subjects who have previously received local radiation therapy may be enrolled if the following conditions are met: more than 4 weeks after the end of radiation therapy ;
- Within 2 weeks before the start of the study, patients were treated with Chinese medicines
- Imaging shows that the tumor has invaded the periphery of important blood vessels or the investigator has determined that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up 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 Hydrochloride Capsule Combined with Furmonertinib MesylateAnlotinib Hydrochloride Capsule: Oral on an empty stomach, once a day, 1 capsule each time, orally for 2 consecutive weeks, stop for 1 week Furmonertinib Mesylate：The dose of Furmonertinib Mesylate is 80 mg once a day, 2 tablets each time, taken orally on an empty stomach before breakfast. Take medicine continuously for 3 weeks (21 days) for 1 cycle. | Drug | Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate |
Primary outcome
Safety and Efficacy of drug therapy
Time frame: up to 4 weeks
The probability and severity of first cycle adverse events (AE) and serious adverse events (SAE) (based on Common Terminology Criteria for Adverse Events 5.0) and abnormal laboratory test indicators;
1 secondary outcome
The overall efficacy was assessed by the investigators
Time frame: up to 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- 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.
Yuankai SHI, Doctor principal investigator
Chinese Academy of Medical Sciences and Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib Hydrochloride Capsule Combined with Furmonertinib Mesylate in people with Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 11 May 2025. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Efficacy of drug therapy (time frame: up to 4 weeks). 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 11 May 2025.