Advanced NSCLC Patients With T790MPhase 2NCT03452592
Efficacy and Safety of Alflutinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Patients With T790M
A Phase 2 study testing Alflutinib in people with Advanced NSCLC Patients With T790M, run by Allist Pharmaceuticals, Inc. at 1 site in China.
Trial summary
This study is conducted to evaluate the efficacy and safety of Alflutinib in locally advanced or metastatic non-small cell lung cancer patients harbouring T790M mutation Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced NSCLC Patients With T790M
- What is being tested?
- Alflutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2018to 14 Mar 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Male or female, aged at least 18 years.
- 2.Histologically or cytologically confirmed, and locally advanced or metastatic NSCLC, who are not suitable for surgery /radiotherapy.
- 3.Patients who have disease progression after continuous previous treatment of 1st/2nd-generation EGFR TKIs (evaluation according to imaging evidence, judged by research center) will be recruited and primary T790M mutation patients are allowed to have received no EGFR-targeting therapy before detection.
- 4.The tissue/cell specimen collected from patients who have received the recent treatment (either TKI or chemotherapy) progression should be confirmed to T790M positive mutation by the detection of central laboratory, while no specimen collection requirements for the primary T790M mutation patients.
- 5. ECOG performance status of 0 to 2. Life expectancy of at least 12 weeks.
- 6. At least one measurable lesion by CT or MRI. The measureable lesion should receive no local treatments, such as, radiotherapy. If the lesions located at the regions which were previously treated are confirmed to progress, they can be chosen as lesion according to RECIST Version 1.1.
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- 7. Organ function must meet the following requirements (patients should receive no blood transfusion, blood product, hematopoietic stimulating factors, and albumin)：
- Absolute neutrophil count >= 1.5 x 109/L, Platelet count >= 75 x109/L, Haemoglobin >= 90 g/L;
- Alanine aminotransferase/Aspartate aminotransferase <= 2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or <= 5 times in the presence of liver metastases;
- Total bilirubin <= 1.5 times ULN if no liver metastases or <= 3 times ULN in the presence of liver metastases;
- Creatinine <=1.5 times ULN concurrent with creatinine clearance >= 50 ml/min (measured or calculated by Cockcroft and Gault equation);
- 8. Females who have fertility potential before menopause should have a pregnancy test in the time period of 7 days prior to start of dosing, should not be breast feeding and must have a negative pregnancy test (blood test or urinalysis) prior to start of dosing; all enrolled patients should take the barrier contraceptive methods during the therapy and three months after therapy
- 9. Patients are volunteered to enroll and sign a written informed consent form, and they can follow the therapeutic schedule and visit plan.
Who cannot join
- 1. Previous treatment as follows: Patients received any cytotoxic chemotherapy or immunotherapy (such as, PD-1 antibody, PD-L1antibody) from a previous treatment regimen or clinical study within 21 days prior to study entry; The time from stopping taking any target cancer drug of a previous treatment to study entry is less than its 5x half-life (such as, the time for erlotinib is less than 8 days, the time for gefinitib is less than 10 days, the time for icotinib is less than 2 days, the time for afatinib is less than 8 days ); The time from stopping taking any studied drug or anti-cancer drug of a previous treatment to study entry is less than its 5x half-life; Patients performed on major surgery within 4 weeks prior to study entry (excluding from and vascular passage-rebuilt surgery and biopsy operation); Patients performed on more than 30% of bone marrow radiotherapy or large area irradiation
- 2. Patients previously treated by 3nd-generation EGFR-TKI , analogous drug (such as Osimertinib (Tagrisso®, AZD9291), Rociletinib (CO-1686), Olmutinib (Olita®,HM61713), ASP8273, EGF816, HS-1029, and avitinib), or their bulk drugs and generic drug。
- 3. Patients were taking and could not stop the drugs within 2 weeks prior to study entry. The drugs are as following:
- Potent inhibitors or inducers of CYP3A4;
- Traditional Chinese medicine and preparations whose therapeutic goal is anti-tumors；Antitumor adjuvant therapy of Traditional Chinese medicine and preparations; Drugs with antitumor activity for patients judged by investigator.
- 4. Unrecovered toxic reaction due to former therapy existed, with over 1 grade of CTCAE (except alopecia) or 2 grade if ever applied DDP curing related neuropathy.
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- 5. Spinal compression, or brain metastasis exhibiting symptoms but untreated (except those exhibit no symptom with stable condition and do not apply corticosteroids for 4 weeks before the trail initiating)
- 6. Any evidence showing severe or inadequate controlled systemic disease. For example patients with inadequate controlled hypertension considered not suitable for the trail or would affect the compliance towards the protocol, with active hemorrhagic tendency, with active infection such as HBV (HBV-DNA≥1000cps/ml), with HCV, with HIV et al (except for HBV carrier those the researcher considered meet the criterion).
- 7. Any condition affecting the drug taking, or significantly affecting the absorption or the pharmacokinetic parameters, include any kind of uncontrollable nausea or vomit, chronic gastroenteropathy, disability in swallowing, and history of gastrointestinal resection or surgery.
- 8. Any condition meet the following cardiac standard: ECG show a QTc>470 msec under resting state (Repeat in 48 hours when a first abnormal discovered, take mean of the two measurements). All kinds of abnormal in cardiac rhythm, conduction and resting ECG profile with clinical significance, for example complete left bundle branch block, 2 or 3 grade of conduction block and a PR interval>250 msec. Any possible factors increasing the risk of QTc extending or leading to arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, any first degree relative suffered from long QT syndrome or undertook unexplained sudden death before 40 years old, or taking any drug leading to a longer QTc.
- 9. Echocardiographic examination: LVEF<50%
- 10. Any history of interstitial lung disease, drug induced interstitial lung disease, radiation pneumonia require steroid therapy or active interstitial lung disease with clinical evidence during recruiting.
- 11. Lung functional examination: FEV1/FVC<70%, and FEV1<30%, or (DLCO%) < 40%.
- 12.Patients with acute onset or ongoing, pulmonary symptoms and interstitial lung disease that the researchers considered not suitable for trail.
- 13. Patients with other factors the researchers considered not suitable for the trail (for example, patients those who not willing to follow the procedure, limitation or requirements, who once experienced bone marrow allotransplantation, who have other kinds of malignant tumor coexisted or who showed allergic to the active ingredients or inactive adjuvant of the investigational drug, as well as drugs with similar chemical structure or in the same class).
- 14. Confirmed mutation of EGFR 20 exon insertion at anytime after the first diagnosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Randomized and OpenⅡb Clinical Trials to Evaluate the Efficacy and Safety of Alflutinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Patients Harbouring T790M Mutation
This study is conducted to evaluate the efficacy and safety of Alflutinib in locally advanced or metastatic non-small cell lung cancer patients harbouring T790M mutation
Read the detailed description
This is a multicenter, randomized and open Ⅱb phase study assessing the efficacy and safety of Alflutinib at doses of 80 mg orally /once daily and 160 mg orally /once daily in patients with locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) harboring acquired T790M mutation after EGFR-TKI treatment or primary T790M mutation.
- Conditions
- Advanced NSCLC Patients With T790M
- Being tested
- Alflutinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlflutinibDrug
Patients take Alflutinib orally once per day at dose of 80 mg or 160 mg
| Study group | Role | What they receive |
|---|---|---|
| The way patients take Alflutinib | Experimental | patients take Alflutinib orally once per day at dose of 80mg or160mg Receives: Drug: Alflutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate of Alflutinib
Evaluation of the objective response rate of Alflutinib in locally advanced or metastatic non-small cell lung cancer patients harbouring acquired T790M mutation by prior therapy with an EGFR-TKI or primary T790M mutation assessed by RECIST 1.1
Measured: CT or MRI at screening and every 2 Cycles (from first dose of multiple dosing) until disease progression or withdrawal from study, whichever came first, assessed up to 52 weeks
Secondary outcomes (5)
Progression free disease of Alflutinib
Progression of tumor was assessed by RECIST 1.1 thereby to evaluate progression free survival
Measured: CT or MRI at screening and every 2 Cycles (from first dose of multiple dosing) until disease progression or withdrawal from study, whichever came first, assessed up to 52 weeks
Overall survival of Alflutinib
Evaluation of the overall survival of Alflutinib in locally advanced or metastatic non-small cell lung cancer patients harbouring acquired T790M mutation by prior therapy with an EGFR-TKI or primary T790M mutation assessed by RECIST 1.1
Measured: CT or MRI at screening and every 2 Cycles (from first dose of multiple dosing) until disease progression or withdrawal from study, whichever came first, assessed up to 52 weeks
Duration of response of Alflutinib
Evaluation of the duration of response of Alflutinib in locally advanced or metastatic non-small cell lung cancer patients harbouring acquired T790M mutation by prior therapy with an EGFR-TKI or primary T790M mutation assessed by RECIST 1.1
Measured: CT or MRI at screening and every 2 Cycles (from first dose of multiple dosing) until disease progression or withdrawal from study, whichever came first, assessed up to 52 weeks
Disease control rate of Alflutinib
Progression of tumor was assessed by RECIST 1.1 thereby to evaluate disease control rate
Measured: CT or MRI at screening and every 2 Cycles (from first dose of multiple dosing) until disease progression or withdrawal from study, whichever came first, assessed up to 52 weeks
Clinical benefit of Alflutinib
Clinical benefit rate was calculated by adding up complete remission, partial remission and stabilization of disease assessed by RECIST 1.1
Measured: CT or MRI at screening and every 2 Cycles (from first dose of multiple dosing) until disease progression or withdrawal from study, whichever came first, assessed up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start30 Apr 2018
- Primary completion21 Apr 2021
- Study completion14 Mar 2024
Why it stopped: Indications have been approved for marketing
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 Advanced NSCLC Patients With T790MStudies of the same condition, open and under way.
- More trials run by Allist Pharmaceuticals, Inc.The 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allist Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452592
- Sponsor's protocol ID
- 20180208
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2018
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shi Y, Hu X, Zhang S, Lv D, Wu L, Yu Q, Zhang Y, Liu L, Wang X, Cheng Y, Ma Z, Niu H, Wang D, Feng J, Huang C, Liu C, Zhao H, Li J, Zhang X, Jiang Y, Gu C. Efficacy, safety, and genetic analysis of furmonertinib (AST2818) in patients with EGFR T790M mutated non-small-cell lung cancer: a phase 2b, multicentre, single-arm, open-label study. Lancet Respir Med. 2021 Aug;9(8):829-839. doi: 10.1016/S2213-2600(20)30455-0. Epub 2021 Mar 26.
PubMed 33780662
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized and OpenⅡb Clinical Trials to Evaluate the Efficacy and Safety of Alflutinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Patients Harbouring T790M Mutation
- ClinicalTrials.gov ID
- NCT03452592
- Acronym / sponsor ID
- 20180208
- Conditions
- Advanced NSCLC Patients With T790M
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Indications have been approved for marketing
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Allist Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 2 Mar 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.
This study is conducted to evaluate the efficacy and safety of Alflutinib in locally advanced or metastatic non-small cell lung cancer patients harbouring T790M mutation
Detailed description
This is a multicenter, randomized and open Ⅱb phase study assessing the efficacy and safety of Alflutinib at doses of 80 mg orally /once daily and 160 mg orally /once daily in patients with locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) harboring acquired T790M mutation after EGFR-TKI treatment or primary T790M mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The way patients take Alflutinib | Experimental | Drug: Alflutinibpatients take Alflutinib orally once per day at dose of 80mg or160mg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1.Male or female, aged at least 18 years.
- 2.Histologically or cytologically confirmed, and locally advanced or metastatic NSCLC, who are not suitable for surgery /radiotherapy.
- 3.Patients who have disease progression after continuous previous treatment of 1st/2nd-generation EGFR TKIs (evaluation according to imaging evidence, judged by research center) will be recruited and primary T790M mutation patients are allowed to have received no EGFR-targeting therapy before detection.
- 4.The tissue/cell specimen collected from patients who have received the recent treatment (either TKI or chemotherapy) progression should be confirmed to T790M positive mutation by the detection of central laboratory, while no specimen collection requirements for the primary T790M mutation patients.
- 5. ECOG performance status of 0 to 2. Life expectancy of at least 12 weeks.
Key exclusion criteria (16 listed)
- 1. Previous treatment as follows: Patients received any cytotoxic chemotherapy or immunotherapy (such as, PD-1 antibody, PD-L1antibody) from a previous treatment regimen or clinical study within 21 days prior to study entry; The time from stopping taking any target cancer drug of a previous treatment to study entry is less than its 5x half-life (such as, the time for erlotinib is less than 8 days, the time for gefinitib is less than 10 days, the time for icotinib is less than 2 days, the time for afatinib is less than 8 days ); The time from stopping taking any studied drug or anti-cancer drug of a previous treatment to study entry is less than its 5x half-life; Patients performed on major surgery within 4 weeks prior to study entry (excluding from and vascular passage-rebuilt surgery and biopsy operation); Patients performed on more than 30% of bone marrow radiotherapy or large area irradiation
- 2. Patients previously treated by 3nd-generation EGFR-TKI , analogous drug (such as Osimertinib (Tagrisso®, AZD9291), Rociletinib (CO-1686), Olmutinib (Olita®,HM61713), ASP8273, EGF816, HS-1029, and avitinib), or their bulk drugs and generic drug。
- 3. Patients were taking and could not stop the drugs within 2 weeks prior to study entry. The drugs are as following:
- 4. Unrecovered toxic reaction due to former therapy existed, with over 1 grade of CTCAE (except alopecia) or 2 grade if ever applied DDP curing related neuropathy.
- 5. Spinal compression, or brain metastasis exhibiting symptoms but untreated (except those exhibit no symptom with stable condition and do not apply corticosteroids for 4 weeks before the trail initiating)
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 |
|---|---|---|
| AlflutinibPatients take Alflutinib orally once per day at dose of 80 mg or 160 mg | Drug | The way patients take Alflutinib |
Primary outcome
Objective response rate of Alflutinib
Time frame: CT or MRI at screening and every 2 Cycles (from first dose of multiple dosing) until disease progression or withdrawal from study, whichever came first, assessed up to 52 weeks
Evaluation of the objective response rate of Alflutinib in locally advanced or metastatic non-small cell lung cancer patients harbouring acquired T790M mutation by prior therapy with an EGFR-TKI or primary T790M mutation assessed by RECIST 1.1
5 secondary outcomes
Progression free disease of Alflutinib
Time frame: CT or MRI at screening and every 2 Cycles (from first dose of multiple dosing) until disease progression or withdrawal from study, whichever came first, assessed up to 52 weeks
Overall survival of Alflutinib
Time frame: CT or MRI at screening and every 2 Cycles (from first dose of multiple dosing) until disease progression or withdrawal from study, whichever came first, assessed up to 52 weeks
Duration of response of Alflutinib
Time frame: CT or MRI at screening and every 2 Cycles (from first dose of multiple dosing) until disease progression or withdrawal from study, whichever came first, assessed up to 52 weeks
Disease control rate of Alflutinib
Time frame: CT or MRI at screening and every 2 Cycles (from first dose of multiple dosing) until disease progression or withdrawal from study, whichever came first, assessed up to 52 weeks
Clinical benefit of Alflutinib
Time frame: CT or MRI at screening and every 2 Cycles (from first dose of multiple dosing) until disease progression or withdrawal from study, whichever came first, assessed up to 52 weeks
Results and safety
The study was stopped early (reason given: Indications have been approved for marketing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Derived from this study: PubMed 33780662Shi Y, Hu X, Zhang S, Lv D, Wu L, Yu Q, Zhang Y, Liu L, Wang X, Cheng Y, Ma Z, Niu H, Wang D, Feng J, Huang C, Liu C, Zhao H, Li J, Zhang X, Jiang Y, Gu C. Efficacy, safety, and genetic analysis of furmonertinib (AST2818) in patients with EGFR T790M mutated non-small-cell lung cancer: a phase 2b, multicentre, single-arm, open-label study. Lancet Respir Med. 2021 Aug;9(8):829-839. doi: 10.1016/S2213-2600(20)30455-0. Epub 2021 Mar 26.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Alflutinib in people with Advanced NSCLC Patients With T790M, run by Allist Pharmaceuticals, Inc. 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 13 inclusion and 16 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: stopped early, as of the sponsor's last update on 3 Apr 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 was stopped early (reason given: Indications have been approved for marketing). Results are not available in the source record.
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?
Objective response rate of Alflutinib (time frame: CT or MRI at screening and every 2 Cycles (from first dose of multiple dosing) until disease progression or withdrawal from study, whichever came first, assessed up to 52 weeks). 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 NCT03452592, 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 3 Apr 2025.