Non Small Cell Lung CancerPhase 2CHAMELEONNCT06020989
Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy
A Phase 2 study testing Lazertinib+Pemetrexed+Carboplatin and Lazertinib in people with Non Small Cell Lung Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Lazertinib is an oral third-generation irreversible tyrosine kinase inhibitor (TKI) that has proved to selectively inhibit EGFR-TKI sensitizing mutations (exon 19 deletion or exon 21 L858R) and be effective in patients with central nervous system (CNS) metastases. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Lazertinib+Pemetrexed+Carboplatin and Lazertinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2023to Dec 2025
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed recurrent or metastatic non-squamous NSCLC without previous treatment experience
- Presence of the sensitising EGFR-mutation (exon 19 deletion and/or L858R) detected by an accredited laboratory.
- Measurable disease as defined according to RECIST v1.1
- Age ≥19 years
- ECOG performance status 0-2
- Life expectancy ≥12 months
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- Adequate haematological function:
- Haemoglobin ≥90 g/L
- Absolute neutrophil count (ANC) ≥ 1.5× 109/L
- Platelet count ≥100× 109/L
- Adequate renal function:
- Serum creatinine ≤1.5x ULN or creatinine clearance ≥50 mL/min (calculated according to Cockcroft-Gault formula, see below).
- Confirmation of creating clearance is only required when serum creatinine is >1.5x ULN.
- Cockcroft-Gault formula:"mL" /"min" "=" ("140-age" ["years" ])"×actual body weight " ["kg" ]/("72×" 〖"Creatinine" 〗"serum" " " ("mg" /"dL" ) ) "(×0.85 if female)"
- Adequate liver function:
- ALT and AST ≤2.5× ULN. If the patient has liver metastases, ALT and AST must be ≤5× ULN
- Total serum bilirubin ≤1.5× ULN. If the patient has documented Gilbert's syndrome (unconjugated hyperbilirubinaemia) ≤3× ULN.
- Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test within 7 days before enrolment.
- Written IC for protocol treatment must be signed and dated by the patient and the investigator prior to any trial-related intervention.
Who cannot join
- Presence of leptomeningeal metastases
- Symptomatic spinal cord compression
- Currently receiving (or unable to stop use prior to receiving the first dose of lazertinib treatment) medications or herbal supplements known to be potent CYP3A4 inducers that cannot be stopped before enrolment and for the duration of the trial.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
- Patients with a resolved or chronic HBV infection are eligible if they are:
- Negative for HBsAg and positive for hepatitis B core antibody [anti-HBc IgG]; or
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- Positive for HBsAg, negative for HBeAg but for >6 months have had transaminases levels below ULN and HBV DNA levels below 2000 IU/mL (i.e., are in an inactive carrier state).
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of lazertinib
- Any of the following cardiac criteria:
- QTcF >470 msec obtained from 3 ECGs, using the screening clinic ECG machine derived QTc value (QTcF: corrected QT interval using Fridericia's formula).
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block or second-degree heart block).
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes (TdP).
- Past medical history of ILD, drug induced ILD, interstitial pneumonitis which required steroid treatment, or any evidence of clinically active ILD
- History of hypersensitivity to active or inactive excipients of lazertinib or drugs with a similar chemical structure or class to lazertinib.
- Patients who should not participate in the trial at the investigator's discretion as they are unlikely to comply with trial procedures, restrictions, and requirements for pregnant or lactation women.
- Both sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method (Please refer to 8.3 for highly effective contraceptive methods) during the trial and up to 6 months after discontinuing lazertinib treatment.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
Sun Min Lim, +82-2227-8068, limlove2008@yuhs.ac
About this study
Official title: A Randomized, Phase 2 Trial of Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy (CHAMELEON)
Lazertinib is an oral third-generation irreversible tyrosine kinase inhibitor (TKI) that has proved to selectively inhibit EGFR-TKI sensitizing mutations (exon 19 deletion or exon 21 L858R) and be effective in patients with central nervous system (CNS) metastases. However, all patients eventually experience disease progression. For patients with MRD, lazertinib plus cytotoxic anticancer drug can prolong the duration of response or even induce complete cure, indicating this combined treatment strategy is considered the safest and most effective.
The objective of this phase 2 prospective two-arm clinical trial is to evaluate the safety and efficacy of lazertinib alone or in combination with cytotoxic chemotherapy in EGFR-mutant (exon 19 deletion or exon 21 L858R) NSCLC patients without ctDNA clearance after lead-in lazertinib. If anticancer drugs are used only for patients with MRD, the risk of resistance development will decrease, improving PFS.
Hypothesis: to evaluate the efficacy defined as the PFS rate of lazertinib alone or in combination with a cytotoxic anticancer drug in EGFR-mutant NSCLC patients without ctDNA clearance after lead-in lazertinib monotherapy.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Lazertinib+Pemetrexed+Carboplatin, Lazertinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lazertinib+Pemetrexed+CarboplatinDrug
Arm A will receive Lazertinib and Pemetrexed, Carboplatin combination. Lazertinib will be given 240 mg once a day daily PO until disease progression or unacceptable toxicity. Pemetrexed(500 mg/m2) will be administered IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. Carboplatin(AUC5) will be administered IV infusions on Day 1 of each 21-day cycle until 4 cycles.
LazertinibDrug
Lazertinib will be given 240 mg once a day daily PO until disease progression or unacceptable toxicity.
LazertinibDrug
Lazertinib will be given 240 mg once a day daily PO until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Lazertinib + chemotherapy combination Receives: Drug: Lazertinib+Pemetrexed+Carboplatin |
| B | Active comparator | Lazertinib monotherapy Receives: Drug: Lazertinib |
| C | Active comparator | Lazertinib monotherapy Receives: Drug: Lazertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
PFS is measured from the date of start of study to the date of disease progression or death from any cause.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sun Min Lim, Principal investigator, Yonsei University Health System, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020989
- Sponsor's protocol ID
- 4-2023-0795
- Acronym
- CHAMELEON
- Status last verified
- Aug 2023
- First submitted
- 27 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase 2 Trial of Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy (CHAMELEON)
- ClinicalTrials.gov ID
- NCT06020989
- Acronym / sponsor ID
- CHAMELEON / 4-2023-0795
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Sep 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.
Lazertinib is an oral third-generation irreversible tyrosine kinase inhibitor (TKI) that has proved to selectively inhibit EGFR-TKI sensitizing mutations (exon 19 deletion or exon 21 L858R) and be effective in patients with central nervous system (CNS) metastases. However, all patients eventually experience disease progression. For patients with MRD, lazertinib plus cytotoxic anticancer drug can prolong the duration of response or even induce complete cure, indicating this combined treatment strategy is considered the safest and most effective.
The objective of this phase 2 prospective two-arm clinical trial is to evaluate the safety and efficacy of lazertinib alone or in combination with cytotoxic chemotherapy in EGFR-mutant (exon 19 deletion or exon 21 L858R) NSCLC patients without ctDNA clearance after lead-in lazertinib. If anticancer drugs are used only for patients with MRD, the risk of resistance development will decrease, improving PFS.
Hypothesis: to evaluate the efficacy defined as the PFS rate of lazertinib alone or in combination with a cytotoxic anticancer drug in EGFR-mutant NSCLC patients without ctDNA clearance after lead-in lazertinib monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Lazertinib+Pemetrexed+CarboplatinLazertinib + chemotherapy combination |
| B | Active comparator | Drug: LazertinibLazertinib monotherapy |
| C | Active comparator | Drug: LazertinibLazertinib monotherapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients with histologically confirmed recurrent or metastatic non-squamous NSCLC without previous treatment experience
- Presence of the sensitising EGFR-mutation (exon 19 deletion and/or L858R) detected by an accredited laboratory.
- Measurable disease as defined according to RECIST v1.1
- Age ≥19 years
- ECOG performance status 0-2
Key exclusion criteria (16 listed)
- Presence of leptomeningeal metastases
- Symptomatic spinal cord compression
- Currently receiving (or unable to stop use prior to receiving the first dose of lazertinib treatment) medications or herbal supplements known to be potent CYP3A4 inducers that cannot be stopped before enrolment and for the duration of the trial.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
- Patients with a resolved or chronic HBV infection are eligible if they are:
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 |
|---|---|---|
| Lazertinib+Pemetrexed+CarboplatinArm A will receive Lazertinib and Pemetrexed, Carboplatin combination. Lazertinib will be given 240 mg once a day daily PO until disease progression or unacceptable toxicity. Pemetrexed(500 mg/m2) will be administered IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. Carboplatin(AUC5) will be administered IV infusions on Day 1 of each 21-day cycle until 4 cycles. | Drug | A |
| LazertinibLazertinib will be given 240 mg once a day daily PO until disease progression or unacceptable toxicity. | Drug | B |
| LazertinibLazertinib will be given 240 mg once a day daily PO until disease progression or unacceptable toxicity. | Drug | C |
Primary outcome
Progression-free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
PFS is measured from the date of start of study to the date of disease progression or death from any cause.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- 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.
Sun Min Lim principal investigator
Yonsei University Health System, Severance 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 Lazertinib+Pemetrexed+Carboplatin and Lazertinib in people with Non Small Cell Lung Cancer, run by Yonsei University at 1 site in South Korea.
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 19 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: status not confirmed, as of the sponsor's last update on 1 Sep 2023. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sun Min Lim (+82-2227-8068, limlove2008@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 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 1 Sep 2023.