ALK-positive Non-small Cell Lung CancerPhase 2NCT04211922
Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
A Phase 2 study testing Alkotinib Capsules in people with ALK-positive Non-small Cell Lung Cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
The main purpose of the study is to evaluate safety and efficacy of Alkotinib capsule in patients with ALK-positive non-small cell lung cancer previously treated with crizotinib.While exploring the relationship between biomarkers and drug efficacy and safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALK-positive Non-small Cell Lung Cancer
- What is being tested?
- Alkotinib Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2020to 11 Oct 2022
- 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
- Evidence of positive ALK.
- Patients must have demonstrated progression during or after crizotinib treatment.
- Age 18 years or older at the time of informed consent.
- Eastern cooperative oncology group performance status (ECOG PS) of 0-2
- At least one measurable lesion by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1).
- Willingness and ability to comply with the trial and follow-up procedures.
Who cannot join
- chemotherapy, radiation therapy, immunotherapy within 4 weeks.
- Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
- Uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Multicenter, Single-arm Study to Evaluate Safety and Efficacy of Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
The main purpose of the study is to evaluate safety and efficacy of Alkotinib capsule in patients with ALK-positive non-small cell lung cancer previously treated with crizotinib.While exploring the relationship between biomarkers and drug efficacy and safety.
Read the detailed description
The drug being tested in this study is called alkotinib. Alkotinib has been demonstrated to benefit people with ALK+ NSCLC.
The study is a non-control study.
The study will enroll approximately 104 participants. All participants will take alkotinib 300mg throughout the study.
This multi-center trial will be conducted in China. The overall time to participate in this study is 3 years. Participants will make multiple visits to the site, and 28 days after last dose of study drug for a follow-up assessment.
- Conditions
- ALK-positive Non-small Cell Lung Cancer
- Being tested
- Alkotinib Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alkotinib CapsulesDrug
Also called ZG0418
Alkotinib 400mg QD
| Study group | Role | What they receive |
|---|---|---|
| Alkotinib 400mg QD | Experimental | 400mg orally once daily. Take Alkotinib at least 1 hour before or at least 2 hours after a meal. Receives: Drug: Alkotinib Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) based on independent radiology review
ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).
Measured: 24 months
Secondary outcomes (2)
Progression-free survival (PFS) as assessed by independent radiology review and investigator
PFS, defined as time from first dose of Alkotinib to progression or death due to any cause.
Measured: 36 months
Overall survival (OS)
OS, defined as time from first dose of Alkotinib to death due to any cause
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start21 Jan 2020
- Primary completion11 Oct 2022
- Study completion11 Oct 2022
Why it stopped: Sponsor R\&D Strategy Adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALK-positive Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caicun Zhou, Doctor, Study chair, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211922
- Sponsor's protocol ID
- ZGALK002
- Status last verified
- Apr 2024
- First submitted
- 23 Dec 2019
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Single-arm Study to Evaluate Safety and Efficacy of Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
- ClinicalTrials.gov ID
- NCT04211922
- Acronym / sponsor ID
- ZGALK002
- Conditions
- ALK-positive Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor R\&D Strategy Adjustment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 11 Oct 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 26 Dec 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 main purpose of the study is to evaluate safety and efficacy of Alkotinib capsule in patients with ALK-positive non-small cell lung cancer previously treated with crizotinib.While exploring the relationship between biomarkers and drug efficacy and safety.
Detailed description
The drug being tested in this study is called alkotinib. Alkotinib has been demonstrated to benefit people with ALK+ NSCLC.
The study is a non-control study.
The study will enroll approximately 104 participants. All participants will take alkotinib 300mg throughout the study.
This multi-center trial will be conducted in China. The overall time to participate in this study is 3 years. Participants will make multiple visits to the site, and 28 days after last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alkotinib 400mg QD | Experimental | Drug: Alkotinib Capsules400mg orally once daily. Take Alkotinib at least 1 hour before or at least 2 hours after a meal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Evidence of positive ALK.
- Patients must have demonstrated progression during or after crizotinib treatment.
- Age 18 years or older at the time of informed consent.
- Eastern cooperative oncology group performance status (ECOG PS) of 0-2
- At least one measurable lesion by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1).
Key exclusion criteria (3 listed)
- chemotherapy, radiation therapy, immunotherapy within 4 weeks.
- Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
- Uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion
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 |
|---|---|---|
| Alkotinib CapsulesAlso: ZG0418Alkotinib 400mg QD | Drug | Alkotinib 400mg QD |
Primary outcome
Objective response rate (ORR) based on independent radiology review
Time frame: 24 months
ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).
2 secondary outcomes
Progression-free survival (PFS) as assessed by independent radiology review and investigator
Time frame: 36 months
Overall survival (OS)
Time frame: 36 months
Results and safety
The study was stopped early (reason given: Sponsor R\&D Strategy Adjustment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
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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.
Caicun Zhou, Doctor study chair
Shanghai Pulmonary Hospital, Shanghai, China
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 Alkotinib Capsules in people with ALK-positive Non-small Cell Lung Cancer, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd 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 6 inclusion and 3 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 26 Apr 2024. 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: Sponsor R\&D Strategy Adjustment). 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 (ORR) based on independent radiology review (time frame: 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 26 Apr 2024.