Non-small Cell Lung Cancer Stage IIIPhase 2PLATINUMNCT05338619
A Study of Lazertinib as Consolidation Therapy in Patients With Locally Advanced, Unresectable, EGFR-Mutant Non-Small Cell Lung Cancer (Stage III) Following Chemoradiation Therapy
A Phase 2 study testing Lazertinib in people with Non-small Cell Lung Cancer Stage III and EGFR Positive Non-small Cell Lung Cancer, run by Sung Yong Lee at 13 sites in South Korea.
Trial summary
The "PACIFIC" trial confirmed that the consolidation therapy with durvalumab in patients with stage III, locally advanced, unresectable NSCLC that had not progressed after definitive platinum-based chemoradiation therapy improved the progression-free survival (PFS) by about 17 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Stage III, EGFR Positive Non-small Cell Lung Cancer, Non-squamous Non-small-cell Lung Cancer
- What is being tested?
- Lazertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 13 sitesSouth Korea
- Study dates
- 30 Jun 2022to 2 Mar 2026
- 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
- 18 years and older
- Histologically and cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) non-squamous cell carcinoma who present with locally advanced, unresectable, Stage III disease
- ECOG PS 0,1
- Expected life expectancy of 6 months and more
- Patients who have received at least 2 cycles of definitive platinum-based concurrent chemoradiation therapy (CCRT) and who must be within 1 to 42 days after completion of radiation therapy
- Patients must not have had disease progression during or following CCRT
- Patients with adequate organ and bone marrow function
- Patients who give in written consent voluntarily to participate in this study
Who cannot join
- History of interstitial lung disease, drug-induced interstitial lung disease, or radiation interstitial pneumonia
- History of other primary malignancy
- Mixed small cell and NSCLC histology
- Prior treatment with EGFR-TKI Therapy
- Unresolved toxicity of CTCAE grade 2 or higher following chemoradiation
- Current history of CTCAE grade 2 or higher pneumonia prior to chemoradiation therapy
Show all 11Show fewer
- Patients with severe hypersensitivity to active ingredient or excipient of the investigational medicinal product
- Pregnant or breastfeeding patients
- Patients who do not agree to contraception with medically acceptable method for at least 6 months after the end of study intervention treatment
- Patients who participated in clinical trials within 4 weeks before participating in this study
- Judgment by the investigator that the patient is unsuitable to participate in this study
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
South Korea13 sites, 13 recruiting
- Recruiting
Kosin University Gospel Hospital
Busan
Jang, 82 51 990 6637
Tae Won Jang, MD, PhD
- Recruiting
Keimyung University Dongsan Hospital
Daegu
Park, 82 53 258 4519
Sun Hyo Park, MD, PhD
- Recruiting
Kyungpook National University Medical Center
Daegu
Shin Yup Lee, MD, PhD, 82 53 200 3091
- Recruiting
Chungnam National University Hospital
Daejeon
Lee, 82 42 280 6135
Jeong Eun Lee, MD, PhD
- Recruiting
Chonnam National University Hospital Hwasun Hospital
Gwangju
Oh, 82 61 379 7869
In-Jae Oh, MD, PhD
- Recruiting
Inha University Hospital
Incheon
Lim, 82 32 890 3894
Jun Hyeok Lim, MD, MS
- Recruiting
Pusan National University Yangsan Hospital
Pusan
Seong Hoon Yoon, MD, PhD, 82 55 360 1415
- Recruiting
Asan Medical Center
Seoul
Choi, 82 2 3010 8358
Chang-Min Choi, MD, PhD
- Recruiting
Hanyang University Seoul Hospital
Seoul
Park, 82 2 2290 9065
Dong Won Park, MD, PhD
- Recruiting
Koera University Guro Hospital
Seoul
Lee, 82 2 2626 1914
Sung Yong Lee, MD, PhD
- Recruiting
Korea University Anam Hospital
Seoul
Su In Choi, MD, PhD, 82 2 920 5439
- Recruiting
Kyung Hee University Hospital
Seoul
Lee, 82 2 958 8511
Seung Hyeun Lee, MD, PhD
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Kim, 82 2228 2268
Eunyoung Kim, MD, PhD
About this study
Official title: A Phase II, Multicenter Study of Lazertinib as Consolidation Therapy in Patients With Locally Advanced, Unresectable, EGFR Mutation Positive Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Chemoradiation Therapy (PLATINUM Trial)
The "PACIFIC" trial confirmed that the consolidation therapy with durvalumab in patients with stage III, locally advanced, unresectable NSCLC that had not progressed after definitive platinum-based chemoradiation therapy improved the progression-free survival (PFS) by about 17 months. However, in PACIFIC, no significant differences between durvalumab and placebo were observed in PFS. Unmet need remains in development of successful consolidation therapy following chemoradiation therapy in patients with EGFR-mutant stage III unresectable NSCLC.
A recent "ADAURA" study showed that Osimertinib as an adjuvant therapy after surgery significantly prolonged disease-free survival in EGFR mutation-positive patients. Lazertinib, like Osimertinib, is a third-generation EGFR TKI agent and has shown excellent anticancer effects in preclinical studies and in early clinical settings. Based on these results of the 3rd generation EGFR TKI, Lazertinib, it is expected that there is a clinical benefit Lazertinib as consolidation therapy.
This study aims to investigate the clinical benefits of Lazertinib (Trade name: LECLAZA Tab) consolidation therapy for patients with EGFR mutation-positive, unresectable stage III NSCLC after definitive platinum-based chemoradiation therapy.
Read the detailed description
This study is designed as a prospective, open-label, single-arm, multicenter, phase II, investigator-initiated trial. A total of 77 patients will participate in the study who have undergone definitive platinum-based concurrent chemoradiation therapy and have no disease progression. Patients are to be enrolled within 1 to 42 days after concurrent chemoradiation therapy and to be administrated with lazertinib 240mg oral once daily until disease progression, or unacceptable toxicity. Patients will visit every 8 weeks and perform CT/MRI tumor evaluation by investigator, and will be followed up for survival every 3 months by phone thereafter. Patients will be followed up till maximum of appropriately 4 years of which 3 years since the last patient enrollment must be.
- Conditions
- Non-small Cell Lung Cancer Stage III, EGFR Positive Non-small Cell Lung Cancer, Non-squamous Non-small-cell Lung Cancer
- Being tested
- Lazertinib
- Keywords
- NSCLC, Non-squamous cell carcinoma, EGFR, EGFR-TKI, 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.
LazertinibDrug
Also called LECLAZA
Lazertinib 240mg (3 Tabs as Laclaza Tab 80mg) once daily in oral can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met.
| Study group | Role | What they receive |
|---|---|---|
| Lazertinib | Experimental | Lazertinib 240mg, oral, QD Receives: Drug: Lazertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
The time from the date of enrollment until the date of disease progression or death (by any cause in the absence of progression) Per RECIST 1.1 as assessed by Investigator.
Measured: Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 years)
Secondary outcomes (5)
Overall survival (OS)
The time from the date of enrollment until the date of death
Measured: Until death (up to maximum of approximately 4 years)
Objective response rate (ORR)
The number (%) of patient at least 1 visit response of Complete response (CR) or Partial response (PR).
Per RECIST 1.1 as assessed by Investigator.
Measured: Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 years)
Duration of response (DoR) Duration of response (DoR)
The time from the date of first documented response until the first date of documented progression (or death in the absence of disease progression) Per RECIST 1.1 as assessed by Investigator.
Measured: Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 years)
Time to death or distant metastasis (TTDM)
The time from the date of enrollment until the first date of distant metastasis or death in the absence of distant metastasis.
Per RECIST 1.1 as assessed by Investigator.
Measured: Until death or distant metastasis (up to maximum of approximately 4 years)
Safety profile : Adverse Events according to CTCAE V5.0
Adverse events, Serious adverse events or other significant safety findings
Measured: every visit (up to maximum of approximately 4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start30 Jun 2022
- Primary completion2 Mar 2026 (estimated)
- Study completion2 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung Cancer Stage IIIStudies 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
- Model description
- Lazertinib treatment group (open-label)
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sung Yong Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Yuhan Corporation
- Responsible party
- Sponsor-investigator, Sung Yong Lee, Korea University Guro Hospital
- Investigators
- Sung Yong Lee, MD, PhD, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338619
- Sponsor's protocol ID
- Korea-Lazertinib-CCRT
- Other IDs
- LASER IIT-010
- Acronym
- PLATINUM
- Status last verified
- Aug 2023
- First submitted
- 14 Apr 2022
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi J, Lee JE, Choi CM, Oh IJ, Lee KY, Jang TW, Lee SH, Kim EY, Park DW, Park SH, Lee SY. A phase II, multicenter study of lazertinib as consolidation therapy in patients with locally advanced, unresectable, EGFR mutation-positive non-small cell lung cancer (stage III) who have not progressed following definitive, platinum-based, chemoradiation therapy (PLATINUM trial). Thorac Cancer. 2022 Dec;13(23):3431-3435. doi: 10.1111/1759-7714.14663. Epub 2022 Oct 19.
PubMed 36259253Wang W, Wang Q, Xu C, Li Z, Song Z, Zhang Y, Cai X, Zhang S, Lian B, Li W, Liu A, Zhan P, Liu H, Lv T, Miao L, Min L, Chen Y, Yuan J, Wang F, Jiang Z, Lin G, Pu X, Rao C, Lv D, Yu Z, Li X, Tang C, Zhou C, Xie C, Zhang J, Guo H, Chu Q, Meng R, Wu J, Zhang R, Wang L, Zhu Y, Hu X, Xie Y, Lin X, Cai J, Lan F, Feng H, Wang L, Yao W, Shi X, Huang J, Chen H, Zhang Y, Sun P, Wan B, Pang F, Xu Z, Wang K, Xia Y, Ye M, Wang D, Wei Q, Feng S, Zhou J, Zhang J, Lv D, Gao W, Kang J, Yu G, Liang X, Yu C, Shi L, Yang N, Wu L, Hong Z, Hong W, Fang M, Zhang Y, Lu Y, Wang G, Ma S, Si L, Fang W, Song Y. Chinese expert consensus on the multidisciplinary management of pneumonitis associated with immune checkpoint inhibitor. Thorac Cancer. 2022 Dec;13(23):3420-3430. doi: 10.1111/1759-7714.14693. Epub 2022 Oct 21.
PubMed 36268845
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 Phase II, Multicenter Study of Lazertinib as Consolidation Therapy in Patients With Locally Advanced, Unresectable, EGFR Mutation Positive Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Chemoradiation Therapy (PLATINUM Trial)
- ClinicalTrials.gov ID
- NCT05338619
- Acronym / sponsor ID
- PLATINUM / Korea-Lazertinib-CCRT
- Conditions
- Non-small Cell Lung Cancer Stage III, EGFR Positive Non-small Cell Lung Cancer, Non-squamous Non-small-cell Lung Cancer
- Keywords
- NSCLC, Non-squamous cell carcinoma, EGFR, EGFR-TKI, Lazertinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Sung Yong LeeUniversity, hospital or other
- Collaborators
- Yuhan Corporation
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 2 Mar 2026 (estimated)
- Study completion
- 2 Mar 2026 (estimated)
- First posted
- 21 Apr 2022 (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 "PACIFIC" trial confirmed that the consolidation therapy with durvalumab in patients with stage III, locally advanced, unresectable NSCLC that had not progressed after definitive platinum-based chemoradiation therapy improved the progression-free survival (PFS) by about 17 months. However, in PACIFIC, no significant differences between durvalumab and placebo were observed in PFS. Unmet need remains in development of successful consolidation therapy following chemoradiation therapy in patients with EGFR-mutant stage III unresectable NSCLC.
A recent "ADAURA" study showed that Osimertinib as an adjuvant therapy after surgery significantly prolonged disease-free survival in EGFR mutation-positive patients. Lazertinib, like Osimertinib, is a third-generation EGFR TKI agent and has shown excellent anticancer effects in preclinical studies and in early clinical settings. Based on these results of the 3rd generation EGFR TKI, Lazertinib, it is expected that there is a clinical benefit Lazertinib as consolidation therapy.
This study aims to investigate the clinical benefits of Lazertinib (Trade name: LECLAZA Tab) consolidation therapy for patients with EGFR mutation-positive, unresectable stage III NSCLC after definitive platinum-based chemoradiation therapy.
Detailed description
This study is designed as a prospective, open-label, single-arm, multicenter, phase II, investigator-initiated trial. A total of 77 patients will participate in the study who have undergone definitive platinum-based concurrent chemoradiation therapy and have no disease progression. Patients are to be enrolled within 1 to 42 days after concurrent chemoradiation therapy and to be administrated with lazertinib 240mg oral once daily until disease progression, or unacceptable toxicity. Patients will visit every 8 weeks and perform CT/MRI tumor evaluation by investigator, and will be followed up for survival every 3 months by phone thereafter. Patients will be followed up till maximum of appropriately 4 years of which 3 years since the last patient enrollment must be.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Lazertinib treatment group (open-label)
| Arm | Type | Receives |
|---|---|---|
| Lazertinib | Experimental | Drug: LazertinibLazertinib 240mg, oral, QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years and older
- Histologically and cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) non-squamous cell carcinoma who present with locally advanced, unresectable, Stage III disease
- ECOG PS 0,1
- Expected life expectancy of 6 months and more
- Patients who have received at least 2 cycles of definitive platinum-based concurrent chemoradiation therapy (CCRT) and who must be within 1 to 42 days after completion of radiation therapy
Key exclusion criteria (11 listed)
- History of interstitial lung disease, drug-induced interstitial lung disease, or radiation interstitial pneumonia
- History of other primary malignancy
- Mixed small cell and NSCLC histology
- Prior treatment with EGFR-TKI Therapy
- Unresolved toxicity of CTCAE grade 2 or higher following chemoradiation
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 |
|---|---|---|
| LazertinibAlso: LECLAZALazertinib 240mg (3 Tabs as Laclaza Tab 80mg) once daily in oral can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met. | Drug | Lazertinib |
Primary outcome
Progression free survival (PFS)
Time frame: Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 years)
The time from the date of enrollment until the date of disease progression or death (by any cause in the absence of progression) Per RECIST 1.1 as assessed by Investigator.
5 secondary outcomes
Overall survival (OS)
Time frame: Until death (up to maximum of approximately 4 years)
Objective response rate (ORR)
Time frame: Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 years)
Duration of response (DoR) Duration of response (DoR)
Time frame: Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 years)
Time to death or distant metastasis (TTDM)
Time frame: Until death or distant metastasis (up to maximum of approximately 4 years)
Safety profile : Adverse Events according to CTCAE V5.0
Time frame: every visit (up to maximum of approximately 4 years)
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.
- Background: PubMed 36259253Choi J, Lee JE, Choi CM, Oh IJ, Lee KY, Jang TW, Lee SH, Kim EY, Park DW, Park SH, Lee SY. A phase II, multicenter study of lazertinib as consolidation therapy in patients with locally advanced, unresectable, EGFR mutation-positive non-small cell lung cancer (stage III) who have not progressed following definitive, platinum-based, chemoradiation therapy (PLATINUM trial). Thorac Cancer. 2022 Dec;13(23):3431-3435. doi: 10.1111/1759-7714.14663. Epub 2022 Oct 19.
- Derived from this study: PubMed 36268845Wang W, Wang Q, Xu C, Li Z, Song Z, Zhang Y, Cai X, Zhang S, Lian B, Li W, Liu A, Zhan P, Liu H, Lv T, Miao L, Min L, Chen Y, Yuan J, Wang F, Jiang Z, Lin G, Pu X, Rao C, Lv D, Yu Z, Li X, Tang C, Zhou C, Xie C, Zhang J, Guo H, Chu Q, Meng R, Wu J, Zhang R, Wang L, Zhu Y, Hu X, Xie Y, Lin X, Cai J, Lan F, Feng H, Wang L, Yao W, Shi X, Huang J, Chen H, Zhang Y, Sun P, Wan B, Pang F, Xu Z, Wang K, Xia Y, Ye M, Wang D, Wei Q, Feng S, Zhou J, Zhang J, Lv D, Gao W, Kang J, Yu G, Liang X, Yu C, Shi L, Yang N, Wu L, Hong Z, Hong W, Fang M, Zhang Y, Lu Y, Wang G, Ma S, Si L, Fang W, Song Y. Chinese expert consensus on the multidisciplinary management of pneumonitis associated with immune checkpoint inhibitor. Thorac Cancer. 2022 Dec;13(23):3420-3430. doi: 10.1111/1759-7714.14693. Epub 2022 Oct 21.
- Individual participant dataSharing planned: No
Related trials for Non-small Cell Lung Cancer Stage III
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 3
Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8
RecruitingPhase 3
A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.
Non Small Cell Lung Cancer
Not yet recruiting
Moderately Hypofractionated Versus Conventional Chemoradiotherapy With Consolidation Immunotherapy in Patients With Unresectable, Non-Targetable Stage III Non Small Cell Lung Cancer (NSCLC)
Stage III NSCLC
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.
Sung Yong Lee, MD, PhD principal investigator
Korea University Guro Hospital
13 sites 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 in people with Non-small Cell Lung Cancer Stage III and EGFR Positive Non-small Cell Lung Cancer, run by Sung Yong Lee at 13 sites 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 8 inclusion and 11 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 13 sites 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 Sung Yong Lee (82 2 2626 1914, syl0801@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 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 NCT05338619, which also lists 2 linked publications.
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.