Completely Resected NSCLC With Common EGFR MutationsPhase 3NCT03381066
A Phase III, Randomized, Multi-center Study to Determine the Efficacy of the Intercalating Combination Treatment of Chemotherapy and Gefitinib or Chemotherapy as Adjuvant Treatment in NSCLC With Common EGFR Mutations.
A Phase 3 study testing gefitinib, pemetrexed,cisplatin and Vinorelbine, cisplatin in people with Completely Resected NSCLC With Common EGFR Mutations, run by Yonsei University at 1 site in South Korea.
Trial summary
This study aims to compare the efficacy of intercalating chemotherapy (gefitinib and pemetrexed/cisplatin) and chemotherapy (navelbine/cisplatin) in completely resected NSCLC with common EGFR mutations. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Completely Resected NSCLC With Common EGFR Mutations
- What is being tested?
- gefitinib, pemetrexed,cisplatin and Vinorelbine, cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Apr 2018to Dec 2022
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completely resected non-squamous cell NSCLC with stage IIa to IIIb (excluding N3) according to Version 8 of the IASLC Staging Manual in Thoracic Oncology
- Tumors with common EGFR mutations (19del or L858R)
- Adequate oran function
Who cannot join
- Patients who were exposed to the chemotherapy or EGFR TKIs for NSCLC.
- Patients with interstitial lung disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Oncology, Yonsei University College of Medicine
Seoul, 03722
Byoung Chul Cho, MD, 82 2 2228 0880, cbc1971@yuhs.ac
About this study
This study aims to compare the efficacy of intercalating chemotherapy (gefitinib and pemetrexed/cisplatin) and chemotherapy (navelbine/cisplatin) in completely resected NSCLC with common EGFR mutations.
- Being tested
- gefitinib, pemetrexed,cisplatin, Vinorelbine, cisplatin
- Keywords
- NSCLC, EGFR, adjuvant, gefitinib, intercalating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gefitinib, pemetrexed,cisplatinDrug
Also called Intercalating arm
- Intercalation phase (Duration: 3weeks x 4 cycles = 12 weeks) Pemetrexed 500mg/m2 D1, Cisplatin 75mg/m2 D1, Gefitinib 250mg D5-18, every 3week
- Maintenance phase (Duration: 1 year) Gefitinib 250mg D1-2
Vinorelbine, cisplatinDrug
Also called chemotherapy alone arm
Duration: 3wks x 4 cycles = 12 weeks Vinorelbine 25mg/m2 D1,8, Cisplatin 75mg/m2 D1 q3week
| Study group | Role | What they receive |
|---|---|---|
| Intercalating arm | Experimental | gefitinib, pemetrexed,cisplatin Receives: Drug: gefitinib, pemetrexed,cisplatin |
| chemotherapy alone arm | Active comparator | Vinorelbine, cisplatin Receives: Drug: Vinorelbine, cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
Time from the randomization to recurrence or any cause of death.
Measured: 5 years
Secondary outcomes (2)
Overall survival
Time from the randomization to death of any cause
Measured: 5 year
Number of participants with treatment-related adverse events as assessed by CTCAE4.0
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start10 Apr 2018
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Completely Resected NSCLC With Common EGFR MutationsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381066
- Sponsor's protocol ID
- 4-2016-0763
- Status last verified
- Jan 2019
- First submitted
- 22 Nov 2017
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Multi-center Study to Determine the Efficacy of the Intercalating Combination Treatment of Chemotherapy and Gefitinib or Chemotherapy as Adjuvant Treatment in NSCLC With Common EGFR Mutations.
- ClinicalTrials.gov ID
- NCT03381066
- Acronym / sponsor ID
- 4-2016-0763
- Keywords
- NSCLC, EGFR, adjuvant, gefitinib, intercalating
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 Dec 2017 (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.
This study aims to compare the efficacy of intercalating chemotherapy (gefitinib and pemetrexed/cisplatin) and chemotherapy (navelbine/cisplatin) in completely resected NSCLC with common EGFR mutations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intercalating arm | Experimental | Drug: gefitinib, pemetrexed,cisplatingefitinib, pemetrexed,cisplatin |
| chemotherapy alone arm | Active comparator | Drug: Vinorelbine, cisplatinVinorelbine, cisplatin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Completely resected non-squamous cell NSCLC with stage IIa to IIIb (excluding N3) according to Version 8 of the IASLC Staging Manual in Thoracic Oncology
- Tumors with common EGFR mutations (19del or L858R)
- Adequate oran function
Key exclusion criteria (2 listed)
- Patients who were exposed to the chemotherapy or EGFR TKIs for NSCLC.
- Patients with interstitial lung disease
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 |
|---|---|---|
| gefitinib, pemetrexed,cisplatinAlso: Intercalating arm* Intercalation phase (Duration: 3weeks x 4 cycles = 12 weeks) Pemetrexed 500mg/m2 D1, Cisplatin 75mg/m2 D1, Gefitinib 250mg D5-18, every 3week * Maintenance phase (Duration: 1 year) Gefitinib 250mg D1-2 | Drug | Intercalating arm |
| Vinorelbine, cisplatinAlso: chemotherapy alone armDuration: 3wks x 4 cycles = 12 weeks Vinorelbine 25mg/m2 D1,8, Cisplatin 75mg/m2 D1 q3week | Drug | chemotherapy alone arm |
Primary outcome
disease-free survival
Time frame: 5 years
Time from the randomization to recurrence or any cause of death.
2 secondary outcomes
Overall survival
Time frame: 5 year
Number of participants with treatment-related adverse events as assessed by CTCAE4.0
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Completely Resected NSCLC With Common EGFR Mutations
Recruiting
A Prospective Cohort Study to Evaluate Molecular pRognostic Factors and Resistance Mechanisms to Osimertinib in Adjuvant Treatment of Completely Resected pIB-IIIA Non-small Cell Lung Carcinoma With Common EGFR Mutations (L858R and Del19)
Non Small Cell Lung Cancer, EGFR Activating Mutation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing gefitinib, pemetrexed,cisplatin and Vinorelbine, cisplatin in people with Completely Resected NSCLC With Common EGFR Mutations, 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 3 inclusion and 2 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 11 Jan 2019. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Byoung Chul Cho, MD (82 2 2228 0880, cbc1971@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (time frame: 5 years). 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 11 Jan 2019.