NSCLC (Non-small Cell Lung Cancer)Phase 2KANNONNCT06015503
A Phase Ⅱ Study Assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins Mutation Patients With Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC)
A Phase 2 study testing PLB1004 in people with NSCLC (Non-small Cell Lung Cancer), run by Avistone Biotechnology Co., Ltd. at 1 site in China.
Trial summary
It is a phase Ⅱ,open-label, single-line, Multiple cohorts, Multicenter study assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins mutation patients with Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Non-small Cell Lung Cancer)
- What is being tested?
- PLB1004
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2023to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Ability to understand and willingness to sign a written informed consent document.
- Aged at least 18 years old.
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB~IV).
- According to the prior treatments having received for advanced disease (platinum containing or/and immunotherapy containing systemic therapy, not more than three lines), participants were divided into two cohorts。
- Participants with EGFR ex20ins mutation.
- ECOG performance status 0 to 1.
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- Life expectancy is not less than 12 weeks.
- At least one measurable lesion as defined by RECISTV1.1.
- Participants must have specific organ and bone marrow function.
Who cannot join
- Having the anticancer therapy prior to the first dose of PLB1004 as follows:
- Any monoclonal antibodies targeting EGFR/HER2/VEGFR within 4 weeks.
- Any cytotoxic drugs or other anticancer drugs from a previous treatment regimen within 14 days.
- Any anticancer herbal medicine within 7 days
- Major surgery within 4 weeks prior to starting PLB1004 or who have not recovered from side effects of such procedure except for the biopsy of Thoracoscopy and the clinical test of Mediastinoscopy could ≤ 7 days prior to starting PLB1004..
- Radiotherapy to lung fields and whole-brain fields ≤4 weeks prior to starting PLB1004. For all other anatomic sites, radiotherapy ≤2 weeks prior to starting PLB1004 or patients who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions is not included.
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- Any anti-EGFR TKI for the EGFR ex20ins mutation.
- Any third-generation anti-EGFR TKI during the treatment having achieved a best overall response of the partial response or complete response.
- Had not recovered from the adverse events and comorbidities caused by prior Systemic chemotherapy ,surgery ,radiotherapy to ≤ Grade 1（except for hair loss and permanent radiotherapy damage ）,the neurological toxicity caused by platinum could ≤ Grade 2.
- Patients receiving treatment with medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with PLB1004 and for the duration of the study:
- Strong inhibitors of CYP3A4
- Strong inducers of CYP3A4
- metformin a MATE transporter substrate
- Patients with spinal cord compression ,brain membrane metastasis and symptomatic central nervous system (CNS), who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study manage CNS symptoms.
- Patients with uncontrolled and symptomatic pleural effusions, peritoneal effusions and pericardial effusions within 4 weeks prior to the start of treatment with PLB1004.
- Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, indolent malignancies that currently do not require treatment, and completely resected carcinoma in situ of any type.
- Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
- Konwn positive hepatitis B (hepatitis B virus , HBV) surface antigen(HBsAg) and HBV-DNA test value≥ULN.
- known positive hepatitis C antibody(anti-HCV) and Anti-HIV(+).Note: Subjects with a prior history of HCV, who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local testing are eligible.
- Having significant or uncontrolled systemic disease, including but not limited to:
- Poorly controlled hypertension (referring to systolic blood pressure>100 mmHg after treatment) .
- Ongoing or active infection.
- Keratitis or onset of ulcerative keratitis.
- Other significant disease, mental illness or laboratory abnormalities that could affect the compliance of the patient on the protocol or investigator's judgement.
- Clinically significant, uncontrolled heart disease, including but not limited to:
- Abnormal QT interval on screening electrocardiogram (ECG), defined as the average value of triplicate QTcF>470ms.
- Have significant arrhythmias such as ventricular arrhythmia, supraventricular arrhythmia which could not be controlled by drugs, nodal arrhythmia and other cardiac arrhythmias which could not be controlled by drugs, Grade≥3 of Congestive heart failure by the New York Heart Association (NYHA).
- Any factors that increase the risk of QTc interval prolongation, such as hypokalemia, genetic long QT syndrome, taking drugs that causing the QT interval prolongation.
- Medical history of deep vein thrombosis or pulmonary embolism within 6 months prior to enrolment or any of the following: Myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary/peripheral artery bypass graft, or any acute coronary syndrome. Or bleeding tendencies or hypercoagulable coagulopathy within 6 months prior to first dose.
- Have active digestive system disease, or major gastrointestinal surgery which may significantly affect the taking or absorption of PLB1004(such as ulcerative lesions, uncontrollable nausea, vomiting, diarrhea, and malabsorption syndrome).
- History of hypersensitivity to active or inactive excipients of PLB1004 or drugs with a similar chemical structure of class to PLB1004.
- pregnant or nursing women.
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ⅱ,Open-label, Single-line, Multiple Cohorts, Multicenter Study Assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins Mutation Patients With Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC)
It is a phase Ⅱ,open-label, single-line, Multiple cohorts, Multicenter study assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins mutation patients with Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC).
Read the detailed description
This a three-stage study consist a Screening Phase (Day -28 to -1), a Treatment Phase (until treatment discontinuation), and a Follow-up Phase (including end of treatment visit (EOT),end of study visit(EOS), safety follow-up and survival follow-up).
- Conditions
- NSCLC (Non-small Cell Lung Cancer)
- Being tested
- PLB1004
- Keywords
- Non-Small-Cell Lung Cancer, EGFR, NSCLC, Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLB1004Drug
PLB1004 is a capsule in the form of 80mg and 40mg.
| Study group | Role | What they receive |
|---|---|---|
| PLB1004 | Experimental | PLB1004 given alone as monotherapy Receives: Drug: PLB1004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective Response Rate (ORR)
To evaluate the Objective Response Rate（ORR）which is defined by IRC as the proportion of subjects with confirmed best overall response of complete response or partial response per RECIST v 1.1.
Measured: 3 years
Secondary outcomes (18)
objective Response Rate (ORR)
To evaluate the Overall Response Rate（ORR）which is defined by investigator as the proportion of subjects with confirmed best overall response of complete response or partial response per RECIST v 1.1.
Measured: 3 years
Disease Control Rate ( DCR)
DCR is defined as the percentage of participants achieving complete or partial response or stable disease of at least 11 weeks as defined per RECIST v 1.1
Measured: 3 years
Duration of Response (DOR)
DOR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first.
Measured: 3 years
Progression-Free Survival (PFS)
PFS is defined as the time from the date the first dose until the date of objective disease progression or death by cause, whichever comes first, based on investigator review according to RECISTv1.1.
Measured: 3 years
Overall Survival (OS)
OS is defined as the time from the date of the first dose until the date of death due to any cause.
Measured: 3 years
Intracranial Overall Response Rate（ORR）
To evaluate the intracranial Overall Response Rate（ORR）which is defined by investigator as the proportion of subjects with Intracranial disease confirmed best overall response of complete response or partial response per RECIST v 1.1.
Measured: 3 years
Intracranial Disease Control Rate (DCR)
Intracranial DCR is defined as the percentage of participants achieving Intracranial disease complete or partial response or stable disease of at least 11 weeks as defined per RECIST v 1.1.
Measured: 3 years
Intracranial Disease Control Rate (DOR)
Intracranial DOR is defined as the time from the date of first documented response (CR or PR) until the date of Intracranial disease documented progression or death, whichever comes first.
Measured: 3 years
Intracranial Progression-Free Survival (PFS)
Intracranial PFS is defined as the time from the date the first dose until the date of objective disease progression or death by cause, whichever comes first, based on investigator review according to RECISTv1.1.
Measured: 3 years
Incidence of Treatment-Emergent Adverse Events (TEAEs)
A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug assessed by CTCAE v5.0.
Measured: 2 years
Incidence of abnormalities in Clinical Laboratory Assessments.
Number of participants with abnormalities in Clinical Laboratory tests（including serum chemistry and hematology） will be reported.
Measured: 2 years
Incidence of abnormalities in Vital Signs.
Number of participants with abnormalities in vital signs(including temperature ,pulse/heart rate，and blood pressure) will be reported.
Measured: 2 years
Area Under the Curve（AUC0-t）of PLB1004
The AUC values are based on the plasma concentration-time profile (from time 0 to Time of the Last Quantifiable Concentration) of PLB1004. To characterize the pharmacokinetics of PLB1004.
Measured: Time Frame: Up to approximately 28 days; pre-dose and multiple time points post-dose
Area Under the Curve（AUC0-∞）of PLB1004
The AUC values are based on the plasma concentration-time profile (from time 0 to infinity) of PLB1004. To characterize the pharmacokinetics of PLB1004.
Measured: Time Frame: Up to approximately 28 days; pre-dose and multiple time points post-dose
Maximum plasma concentration (Cmax) of PLB1004
The Cmax values are based on the plasma concentration-time profile of PLB1004. To characterize the pharmacokinetics of PLB1004.
Measured: Time Frame: Up to approximately 28 days; pre-dose and multiple time points post-dose
Time to maximum plasma concentration (Tmax) of PLB1004
The Tmax values are based on the plasma concentration-time profile of PLB 1004.To characterize the pharmacokinetics of PLB1004.
Measured: Time Frame: Up to approximately 28 days; pre-dose and multiple time points post-dose
Half-life time (t1/2) of PLB1004
The t1/2 values are based on the terminal disposition Phase Half-life for PLB1004 and its Active Metabolites. To characterize the pharmacokinetics of PLB1004.
Measured: Time Frame: Up to approximately 28 days; pre-dose and multiple time points post-dose
Apparent clearance (CL/F) of PLB1004
The CL/F values are based on the apparent clearance after extravascular administration for PLB1004. To characterize the pharmacokinetics of PLB1004.
Measured: Time Frame: Up to approximately 28 days; pre-dose and multiple time points post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start21 Jul 2023
- Primary completion6 Mar 2025
- Study completion30 Dec 2026 (estimated)
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 NSCLC (Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- 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
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avistone Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yilong Wu, MD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015503
- Sponsor's protocol ID
- PLB1004-II-01
- Acronym
- KANNON
- Status last verified
- May 2026
- First submitted
- 18 Aug 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang JJ, Mu Y, Wang ZH, Duan JC, Zhang Y, Wu L, Zhong H, Zhao J, Yao Y, Wang P, Li XL, Yang RX, Min XH, Lv DQ, Xu HP, Fu ZM, Shen B, Sun LH, Wang CL, Zhou JY, Xu RL, Ma HW, Zhao YQ, Shi HP, Zhang PL, Xue WZ, Han D, Zheng Y, Wu YL. Andamertinib in Advanced NSCLC With EGFR Exon 20 Insertions After Platinum-Based Chemotherapy or Immunotherapy: Results From the Phase 2 KANNON Study. J Thorac Oncol. 2026 Mar;21(3):103518. doi: 10.1016/j.jtho.2025.11.008. Epub 2025 Nov 15.
PubMed 41248848
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ,Open-label, Single-line, Multiple Cohorts, Multicenter Study Assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins Mutation Patients With Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC)
- ClinicalTrials.gov ID
- NCT06015503
- Acronym / sponsor ID
- KANNON / PLB1004-II-01
- Conditions
- NSCLC (Non-small Cell Lung Cancer)
- Keywords
- Non-Small-Cell Lung Cancer, EGFR, NSCLC, Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Avistone Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 29 Aug 2023 (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.
It is a phase Ⅱ,open-label, single-line, Multiple cohorts, Multicenter study assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins mutation patients with Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC).
Detailed description
This a three-stage study consist a Screening Phase (Day -28 to -1), a Treatment Phase (until treatment discontinuation), and a Follow-up Phase (including end of treatment visit (EOT),end of study visit(EOS), safety follow-up and survival follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PLB1004 | Experimental | Drug: PLB1004PLB1004 given alone as monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ability to understand and willingness to sign a written informed consent document.
- Aged at least 18 years old.
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB~IV).
- According to the prior treatments having received for advanced disease (platinum containing or/and immunotherapy containing systemic therapy, not more than three lines), participants were divided into two cohorts。
- Participants with EGFR ex20ins mutation.
Key exclusion criteria (33 listed)
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 |
|---|---|---|
| PLB1004PLB1004 is a capsule in the form of 80mg and 40mg. | Drug | PLB1004 |
Primary outcome
objective Response Rate (ORR)
Time frame: 3 years
To evaluate the Objective Response Rate（ORR）which is defined by IRC as the proportion of subjects with confirmed best overall response of complete response or partial response per RECIST v 1.1.
18 secondary outcomes
objective Response Rate (ORR)
Time frame: 3 years
Disease Control Rate ( DCR)
Time frame: 3 years
Duration of Response (DOR)
Time frame: 3 years
Progression-Free Survival (PFS)
Time frame: 3 years
Overall Survival (OS)
Time frame: 3 years
Intracranial Overall Response Rate（ORR）
Time frame: 3 years
Intracranial Disease Control Rate (DCR)
Time frame: 3 years
Intracranial Disease Control Rate (DOR)
Time frame: 3 years
Intracranial Progression-Free Survival (PFS)
Time frame: 3 years
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: 2 years
Incidence of abnormalities in Clinical Laboratory Assessments.
Time frame: 2 years
Incidence of abnormalities in Vital Signs.
Time frame: 2 years
Area Under the Curve（AUC0-t）of PLB1004
Time frame: Time Frame: Up to approximately 28 days; pre-dose and multiple time points post-dose
Area Under the Curve（AUC0-∞）of PLB1004
Time frame: Time Frame: Up to approximately 28 days; pre-dose and multiple time points post-dose
Maximum plasma concentration (Cmax) of PLB1004
Time frame: Time Frame: Up to approximately 28 days; pre-dose and multiple time points post-dose
Time to maximum plasma concentration (Tmax) of PLB1004
Time frame: Time Frame: Up to approximately 28 days; pre-dose and multiple time points post-dose
Half-life time (t1/2) of PLB1004
Time frame: Time Frame: Up to approximately 28 days; pre-dose and multiple time points post-dose
Apparent clearance (CL/F) of PLB1004
Time frame: Time Frame: Up to approximately 28 days; pre-dose and multiple time points post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 41248848Yang JJ, Mu Y, Wang ZH, Duan JC, Zhang Y, Wu L, Zhong H, Zhao J, Yao Y, Wang P, Li XL, Yang RX, Min XH, Lv DQ, Xu HP, Fu ZM, Shen B, Sun LH, Wang CL, Zhou JY, Xu RL, Ma HW, Zhao YQ, Shi HP, Zhang PL, Xue WZ, Han D, Zheng Y, Wu YL. Andamertinib in Advanced NSCLC With EGFR Exon 20 Insertions After Platinum-Based Chemotherapy or Immunotherapy: Results From the Phase 2 KANNON Study. J Thorac Oncol. 2026 Mar;21(3):103518. doi: 10.1016/j.jtho.2025.11.008. Epub 2025 Nov 15.
- 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.
Yilong Wu, MD principal investigator
Guangdong Provincial People's Hospital
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 PLB1004 in people with NSCLC (Non-small Cell Lung Cancer), run by Avistone Biotechnology 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 9 inclusion and 33 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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) (time frame: 3 years). 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 NCT06015503, 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 22 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.