Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations (KANNON-5)

March 18, 2026 updated by: Avistone Biotechnology Co., Ltd.

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Guangzhou, China
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years at the time of ICF signing.
  2. Histologically or cytologically confirmed, unresectable locally advanced (Stage IIIB or IIIC) or metastatic (Stage IV) non-squamous non-small cell lung cancer (NSCLC).
  3. Confirmed EGFR atypical mutation.
  4. No prior systemic therapy for locally advanced or metastatic NSCLC.
  5. At least one measurable lesion as defined by RECIST v1.1.
  6. ECOG PS ≤1.
  7. Life expectancy≥12 weeks.
  8. Adequate organ function confirmed within 7 days prior to the first dose of study treatment
  9. 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.
  10. Non-sterilized males: Abstinence or contraception use; No sperm donation.
  11. Willing and able to provide signed ICF and to comply with all requirements and restrictions listed in the ICF and this study protocol.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Andamertinib with or without platinum-based chemothsrapy versus platinum-based chemotherapy
PLB1004, oral, QD Platinum-based chemotherapy， injection, once every 21-day
Drug: PLB1004
Andamertinib with or without platinum-based chemothsrapy versus platinum-based chemotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Time Frame: Up to 3 years
In phase II，Incidence of Treatment-Emergent Adverse Events (TEAEs)
Up to 3 years
RP3D or recommended phase 3 treatment regimen
Time Frame: Up to 3 years
In phase II, choose the RP3D per gained safety and efficacy data
Up to 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to 3 years
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
Up to 3 years
Duration of Response(DOR)
Time Frame: up to 3 years
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
up to 3 years
Disease Control Rate(DCR)
Time Frame: up to 3 years
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
up to 3 years
Progression-Free Survival(PFS)
Time Frame: up to 3 years
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
up to 3 years
6-month Progression-Free Survival Rate
Time Frame: up to 3 years
The proportion of subjects who did not experience disease progression or death within 6 months after receiving treatment.
up to 3 years
6-month Overall Survival Rate
Time Frame: up to 3 years
The proportion of subjects who did not experience death within 6 months after receiving treatment.
up to 3 years
Assess the PK characteristics of Andamertinib
Time Frame: 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)
Plasma concentration of Andamertinib
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Avistone Biotechnology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PLB1004-II/III-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings