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AzTrials

Non-Small-Cell Lung CancerPhase 2KANNON-5NCT07336732

Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations

A Phase 2 study testing PLB1004 in people with Non-Small-Cell Lung Cancer, run by Avistone Biotechnology Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is an open-label, randomized, multicenter phase II/III clinical trial designed to evaluate the efficacy, safety, and tolerability of Andamertinib with or without platinum-based chemothsrapy versus platinum-based chemotherapy in previously untreated participants with locally advanced or metastatic… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small-Cell Lung Cancer
What is being tested?
PLB1004
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
11 Mar 2026to Jan 2029
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

  • Age ≥18 years at the time of ICF signing.
  • Histologically or cytologically confirmed, unresectable locally advanced (Stage IIIB or IIIC) or metastatic (Stage IV) non-squamous non-small cell lung cancer (NSCLC).
  • Confirmed EGFR atypical mutation.
  • No prior systemic therapy for locally advanced or metastatic NSCLC.
  • At least one measurable lesion as defined by RECIST v1.1.
  • ECOG PS ≤1.
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  • Life expectancy≥12 weeks.
  • Adequate organ function confirmed within 7 days prior to the first dose of study treatment
  • Female participants must use adequate contraceptive measures during study participation and for 90 days after the last dose of study treatment and must not be breastfeeding; female subjects not of childbearing potential must meet at least one of the following criteria at screening: Postmenopausal status; Documentation of irreversible surgical sterilization.
  • Non-sterilized males: Abstinence or contraception use; No sperm donation.
  • Willing and able to provide signed ICF and to comply with all requirements and restrictions listed in the ICF and this study protocol.

Who cannot join

  • Presence of specific genetic alterations for which approved targeted therapies are available.
  • Recent participation (within 28 days) in another interventional clinical trial.
  • Major surgery within 28 days prior to study entry or planned during the study period.
  • Recent use of anti-tumor traditional proprietary medicine or local anti-tumor therapy.
  • Need for specific concomitant medications (e.g., metformin) that cannot be paused during the study.
  • History of another active malignancy within the past 5 years (except for specific cured cancers).
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  • Toxicities from prior therapy have not recovered to acceptable levels.
  • Presence of symptomatic or uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression.
  • Symptomatic and uncontrolled third-space fluid accumulations (e.g., pleural effusion, ascites).
  • Severe cardiovascular/cerebrovascular disease or risk factors (e.g., heart failure, history of myocardial infarction, QT prolongation, uncontrolled hypertension, etc.).
  • History or presence of interstitial lung disease, or drug/radiation-related pneumonitis.
  • Active autoimmune or inflammatory diseases.
  • Active, uncontrolled infection (including HBV, HCV, HIV, syphilis, tuberculosis, etc.).
  • Gastrointestinal disorders or surgery affecting drug ingestion or absorption.
  • Active keratitis or ulcerative keratitis.
  • History of hypersensitivity to the study drug, its analogs, or chemotherapy drugs (pemetrexed/platinum agents).
  • Recent administration (within 30 days) of a live attenuated vaccine.
  • Psychiatric disorders or substance abuse potentially affecting compliance.
  • Any other condition deemed by the investigator as unsuitable for study participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Haimeng Li contact

+86 17610831060

lihaimeng@pearlbio.cn

China1 site, 1 recruiting

  • Sun Yat-Sen University Cancer Center

    Guangzhou

    LI Zhang, +86 13948537070, zhangli@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: An Open-label, Randomized, Multicenter Phase II/III Study to Evaluate the Efficacy and Safety of Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Harboring Atypical EGFR Mutations Who Have Not Received Prior Systematic Therapy

This study is an open-label, randomized, multicenter phase II/III clinical trial designed to evaluate the efficacy, safety, and tolerability of Andamertinib with or without platinum-based chemothsrapy versus platinum-based chemotherapy in previously untreated participants with locally advanced or metastatic non-squamous NSCLC harboring EGFR atypical mutations. The study comprises two stages: phase II (dose-exploration stage) and phase III (pivotal study stage)

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).

Being tested
PLB1004
Keywords
Non-Small-Cell Lung Cance, EGFR, PACC, L861Q, Lung Cancer, EGFR ex20ins
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

    Andamertinib with or without platinum-based chemothsrapy versus platinum-based chemotherapy

Study groups in NCT07336732
Study groupRoleWhat they receive
Andamertinib with or without platinum-based chemothsrapy versus platinum-based chemotherapyExperimentalPLB1004, oral, QD Platinum-based chemotherapy， injection, once every 21-day
Receives: Drug: PLB1004

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).

    In phase II，Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Measured: Up to 3 years

  2. RP3D or recommended phase 3 treatment regimen

    In phase II, choose the RP3D per gained safety and efficacy data

    Measured: Up to 3 years

Secondary outcomes (7)

  1. 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 v1.1

    Measured: Up to 3 years

  2. 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 frst

    Measured: up to 3 years

  3. Disease Control Rate(DCR)

    The percentage of tumor patients achieving complete remission (CR), partial remission (PR), or stable disease (SD) following treatment, relative to the total number of evaluable subjects

    Measured: up to 3 years

  4. 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 RECIST v1.1

    Measured: up to 3 years

  5. 6-month Progression-Free Survival Rate

    The proportion of subjects who did not experience disease progression or death within 6 months after receiving treatment.

    Measured: up to 3 years

  6. 6-month Overall Survival Rate

    The proportion of subjects who did not experience death within 6 months after receiving treatment.

    Measured: up to 3 years

  7. Assess the PK characteristics of Andamertinib

    Plasma concentration of Andamertinib

    Measured: On cycle1of day 1and cycle3of day1, samples were collected within 2 hours prior to dosing and 4 hours post-dosing,On Day 1of Cycle 2, Cycle 5, Cycle 7, and all subsequent odd-numbered cycles collected within 2hours prior to dosing(each cycle is 21days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2026
  2. Study start11 Mar 2026
  3. Primary completionNov 2026 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07336732
Sponsor's protocol ID
PLB1004-II/III-01
Acronym
KANNON-5
Status last verified
Mar 2026
First submitted
18 Dec 2025
Last updated
20 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PLB1004 in people with 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 11 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 20 Mar 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?

Contact Haimeng Li (+86 17610831060, lihaimeng@pearlbio.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). (time frame: Up to 3 years). The study lists 2 primary outcomes in all. 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 NCT07336732.

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 20 Mar 2026.

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