NSCLCPhase 3NCT02795884
Adjuvant Erlotinib Intercalating Chemotherapy or Adjuvant Chemotherapy Alone in NSCLC With Common EGFR Mutation
A Phase 3 study testing intercalation therapy using pemetrexed, cisplatin and erlotinib and Vinorelbine, cisplatin in people with NSCLC, run by Yonsei University.
Trial summary
This study will be performed as a local multicenter, randomized, phase III clinical study. It will compare the adjuvant chemotherapy in Stage IB-IIIA NSCLC with common EGFR mutation (Exon 19 deletion or L858R) who underwent total resection and the Erlotinib-Intercalation adjuvant chemotherapy with the chemotherapy… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- intercalation therapy using pemetrexed, cisplatin and erlotinib and Vinorelbine, cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Nov 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A screening examination should be implemented within 14 after obtaining the informed consent, and the treatment should be started within 14 days after the randomization of subjects. Subjects who are applicable to all of the following criteria will be eligible for inclusion in this clinical study.
- Stage IB-IIIA Non-squamous NSCLC (Based on AJCC Version 7 TNM Disease Stages)
- Surgically complete resection
- Confirmed with Exon 19 deletion or L858R EGFR mutation
- Complete recovery from the surgery. The period up to the post-operative randomization can be 3 weeks at minimum up to 8 weeks at maximum.
- Age to be ≥ 19 years old
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- Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patients who are not pregnant or breastfeeding
- Appropriate functions of bone marrow, liver and kidney, when assessed with the following requirements of the laboratory tests to be conducted within 14 days before the initial dose of the study drug:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Total bilirubin ≤ 1.5 times greater than the upper limit of normal
- ALT and AST ≤ 2.5 times greater than the upper limit of normal
- Alkaline phosphatase ≤ 2.5 times greater than the upper limit of normal
- INR and PTT ≤ 1.5 times greater than the upper limit of normal
- Appropriate renal function: Serum creatinine ≤ 1.25 × upper limit of normal, or serum creatinine clearance according to Cockcroft-Gault formula(below) ≥50 mL/min
- Woman CrCl = (140- age [years old]) x weight (kg) x 0.85 72 x serum creatinine (mg/dL)
- Man CrCl = (140- age [years old]) x weight (kg) x 1.00 72 x serum creatinine (mg/dL)
- Patients who are capable of complying with the clinical study protocol and who can take medication orally
- Patient who can hear sufficient explanation and sign on the informed consent form
Who cannot join
- Any subject who shows any of the following criteria should be excluded from this clinical study:
- Patient identified with T790M mutation
- Treatable with topical treatments (radiotherapy or surgery)
- Previous treatment to inhibit the human epidermal growth factor receptor (EGFR) (e.g. erlotinib, gefitinib, cetuximab, trastuzumab, etc.)
- Prior systemic chemotherapy
- Any prior known hypersensitive reaction to the study agents
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- CTCAE> grade 2 clinically significant active infection
- Any known infection with Human Immunodeficiency Virus (HIV) or chronic hepatitis type B or type C virus For the patients positive to chronic hepatitis type B or type C virus without elevation of AST/ALT, their inclusion/exclusion will be determined at the discretion of the investigator.
- Seizures in need of treatment (steroid or antiepileptic treatment)
- Medical history of interstitial lung disease
- Medical history of organ allograft within six months
- Subjects under dialysis
- A subject diagnosed with another cancer within 3 years before participating in this clinical study (treated carcinoma in situ of the cervix, treated skin basal cell carcinoma, and treated superficial bladder tumors [Ta and Tis] will not be applicable). For surgically completely resected thyroid cancer, it will be determined at the discretion of the investigator.
- Unstable or any status that would potentially put the subject in danger or that would interfere with compliance of the subject in the clinical study.
- Treatment with the investigational products other than the one to be used in this clinical study during participation in the clinical study or within 4 weeks prior to participation in the clinical study
- Pregnant or breastfeeding women. The women at childbearing ages should show negative response to the serum pregnancy test being conducted within 7 days before the initial administration of the study drug. Not only the women at childbearing ages, but also men who give consent to use appropriate contraceptive methods before entering the clinical study and during the period of the clinical study including 30 days after the last dose of the study drug. Post-menopausal women are defined as:
- With no menstruation at least for 12 months, at the age >50 years old, or
- With no natural menstruation at least for 6 months and the level of follicle-stimulating hormone (FSH) is in the post-menopausal range (>40 mIU/mL) at the age ≤50 years old, or
- Bilateral oophorectomy Men and women who are to be enrolled in this clinical study must use appropriate blocking contraceptive methods in prior to and during the clinical study. Appropriate contraceptive methods include implant or combined oral contraceptive agent-utilized hormone contraception, some intrauterine contraceptive device, bilateral tubal ligation, hysterectomy, or vasectomy of the partner. In addition, use of condom is required for the subject or his/her partner.
- Subjects who are unable to swallow oral medication or with all types of absorption disorders
- In addition, when the investigator determines it is not adequate to perform the study due to serious systemic diseases.
About this study
This study will be performed as a local multicenter, randomized, phase III clinical study. It will compare the adjuvant chemotherapy in Stage IB-IIIA NSCLC with common EGFR mutation (Exon 19 deletion or L858R) who underwent total resection and the Erlotinib-Intercalation adjuvant chemotherapy with the chemotherapy alone. The patients will be randomly assigned to the Intercalation combination chemotherapy regimen and the chemotherapy alone regimen at the ratio of 1:1. The treatment regimen of each arm is as follows.
- Conditions
- NSCLC
- Being tested
- intercalation therapy using pemetrexed, cisplatin and erlotinib, Vinorelbine, cisplatin
- Keywords
- Lung cancer, NSCLC, adjuvant treatment
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intercalation therapy using pemetrexed, cisplatin and erlotinibDrug
During the intercalation phase of the initial 12-week period, erlotinib is to be orally administered at the dose of 150 mg daily from Day 8 to Day 21 at every cycle of 21 days. During the maintenance phase after 12 weeks, it is orally administered at the cycle of 28 days without a wash-out period at the dose of 150 mg daily for one year. The combination of pemetrexed and cisplatin will be administered for 4 cycles in total by each cycle of 21 days, and it is to be administered by intravenous (IV) infusion on every Day 1. Pemetrexed 500 mg/m2 will be diluted in 100 ml of 0.9% saline solution and will be administered by intravenous (IV) infusion for 10 minutes. Cisplatin 75 mg/m2 will be diluted in 150 ml of 0.9% saline solution and will be administered by intravenous (IV) infusion for 10 to 15 minutes. The combination of pemetrexed and cisplatin will be administered for 4 cycles in total by each cycle of 21 days, and it is to be administered by intravenous (IV) infusion on every Day 1.
Vinorelbine, cisplatinDrug
Vinorelbine 25mg/m2 will be diluted in 50 ml of 0.9% saline solution and will be administered by intravenous (IV) infusion for 6 to 10 minutes and then wash the catheter using 100 ml of 0.9% saline solution. Cisplatin 75 mg/m2 will be diluted in 150 ml of 0.9% saline solution and will be administered by intravenous (IV) infusion for 10 to 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intercalation arm | Experimental | * Intercalation phase (Duration: 3wks x 4 cycles = 12 wks) Pemetrexed 500mg/m2 D1, Cisplatin 75mg/m2 D1, Erlotinib 150mg D8-21 q3wks
* Maintenance phase (Duration: 1 year) Erlotinib 150mg D1-28 Receives: Drug: intercalation therapy using pemetrexed, cisplatin and erlotinib |
| Chemotherapy alone arm | Active comparator | Duration: 3wks x 4 cycles = 12 wks Vinorelbine 25mg/m2 D1,8, Cisplatin 75mg/m2 D1 q3wks Receives: Drug: Vinorelbine, cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
Time from randomization to disease recurrence or death of any cause
Measured: 3 years
Secondary outcomes (2)
Overall survival (OS)
Measured: 3 years
Treatment-related adverse events assessed by CTCAE v4.0
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (estimated)
Why it stopped: Because of reconsideration of using erlotinib(EGFR Tyrosine kinase inhibitor) as adjuvant aim
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795884
- Sponsor's protocol ID
- 4-2015-0926
- Status last verified
- Dec 2016
- First submitted
- 24 Feb 2016
- Last updated
- 30 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: no plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Erlotinib Intercalating Chemotherapy or Adjuvant Chemotherapy Alone in NSCLC With Common EGFR Mutation
- ClinicalTrials.gov ID
- NCT02795884
- Acronym / sponsor ID
- 4-2015-0926
- Conditions
- NSCLC
- Keywords
- Lung cancer, NSCLC, adjuvant treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because of reconsideration of using erlotinib(EGFR Tyrosine kinase inhibitor) as adjuvant aim
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 10 Jun 2016 (estimated)
- 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 will be performed as a local multicenter, randomized, phase III clinical study. It will compare the adjuvant chemotherapy in Stage IB-IIIA NSCLC with common EGFR mutation (Exon 19 deletion or L858R) who underwent total resection and the Erlotinib-Intercalation adjuvant chemotherapy with the chemotherapy alone. The patients will be randomly assigned to the Intercalation combination chemotherapy regimen and the chemotherapy alone regimen at the ratio of 1:1. The treatment regimen of each arm is as follows.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intercalation arm | Experimental | Drug: intercalation therapy using pemetrexed, cisplatin and erlotinib* Intercalation phase (Duration: 3wks x 4 cycles = 12 wks) Pemetrexed 500mg/m2 D1, Cisplatin 75mg/m2 D1, Erlotinib 150mg D8-21 q3wks * Maintenance phase (Duration: 1 year) Erlotinib 150mg D1-28 |
| Chemotherapy alone arm | Active comparator | Drug: Vinorelbine, cisplatinDuration: 3wks x 4 cycles = 12 wks Vinorelbine 25mg/m2 D1,8, Cisplatin 75mg/m2 D1 q3wks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- A screening examination should be implemented within 14 after obtaining the informed consent, and the treatment should be started within 14 days after the randomization of subjects. Subjects who are applicable to all of the following criteria will be eligible for inclusion in this clinical study.
- Woman CrCl = (140- age [years old]) x weight (kg) x 0.85 72 x serum creatinine (mg/dL)
- Man CrCl = (140- age [years old]) x weight (kg) x 1.00 72 x serum creatinine (mg/dL)
- Patients who are capable of complying with the clinical study protocol and who can take medication orally
- Patient who can hear sufficient explanation and sign on the informed consent form
Key exclusion criteria (21 listed)
- Any subject who shows any of the following criteria should be excluded from this clinical study:
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 |
|---|---|---|
| intercalation therapy using pemetrexed, cisplatin and erlotinibDuring the intercalation phase of the initial 12-week period, erlotinib is to be orally administered at the dose of 150 mg daily from Day 8 to Day 21 at every cycle of 21 days. During the maintenance phase after 12 weeks, it is orally administered at the cycle of 28 days without a wash-out period at the dose of 150 mg daily for one year. The combination of pemetrexed and cisplatin will be administered for 4 cycles in total by each cycle of 21 days, and it is to be administered by intravenous (IV) infusion on every Day 1. Pemetrexed 500 mg/m2 will be diluted in 100 ml of 0.9% saline solution and will be administered by intravenous (IV) infusion for 10 minutes. Cisplatin 75 mg/m2 will be diluted in 150 ml of 0.9% saline solution and will be administered by intravenous (IV) infusion for 10 to 15 minutes. The combination of pemetrexed and cisplatin will be administered for 4 cycles in total by each cycle of 21 days, and it is to be administered by intravenous (IV) infusion on every Day 1. | Drug | Intercalation arm |
| Vinorelbine, cisplatinVinorelbine 25mg/m2 will be diluted in 50 ml of 0.9% saline solution and will be administered by intravenous (IV) infusion for 6 to 10 minutes and then wash the catheter using 100 ml of 0.9% saline solution. Cisplatin 75 mg/m2 will be diluted in 150 ml of 0.9% saline solution and will be administered by intravenous (IV) infusion for 10 to 15 minutes. | Drug | Chemotherapy alone arm |
Primary outcome
Disease-free survival (DFS)
Time frame: 3 years
Time from randomization to disease recurrence or death of any cause
2 secondary outcomes
Overall survival (OS)
Time frame: 3 years
Treatment-related adverse events assessed by CTCAE v4.0
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
- Individual participant dataSharing planned: No. no plan to share data
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intercalation therapy using pemetrexed, cisplatin and erlotinib and Vinorelbine, cisplatin in people with NSCLC, run by Yonsei University.
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 20 inclusion and 21 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: withdrawn, as of the sponsor's last update on 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: 3 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 30 Dec 2016.