Non-small Cell Lung Cancer Stage IIIPhase 2NCT01683175

Erlotinib in Post Radical Operation NSCLC Patients With EGFR Mutation

A Phase 2 study testing Erlotinib, cis-platinum and Vinorelbine in people with Non-small Cell Lung Cancer Stage III, run by Tianjin Medical University Cancer Institute and Hospital at 15 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This study is to compare 2-year Disease Free Survival Rate (DFSR) in post radical operation IIIA Non-Small Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR) 19 or 21 exon mutation treated Erlotinib vs NP chemotherapy as adjuvant therapy. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non-small Cell Lung Cancer Stage III
What is being tested?: Erlotinib, cis-platinum and Vinorelbine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 15 sitesChina
Study dates: Aug 2012to Oct 2020
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

IIIA NSCLC patients according to TMN-staging of Lung Staging Standard version 7 2009, confirmed by histopathology or cytology after radical operation, and having EGFR exon 19 deletion mutation or exon 21 L858R single base substitution;
Accept study adjuvant therapy within 6 weeks post radical operation;
ECOP PS 0-1; Life expectancy ≥12 weeks;
Hematology: absolute neutrophil count (ANC) ≥1.5×10^9/L; platelet count ≥100×10^9/L; hemoglobin concentration ≥ 9.0 g/dL (permit to maintain hematologic criteria by blood transfusion);
Liver Function: TBil ≤1.5xULN; ALT and AST ≤2.5xULN;
Renal Function: Cr ≤1.25xULN, and Ccr ≥60ml/min;

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Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days before study treatment;
Signed inform consent form by patient or his/her legal representative;
Comply with study protocol and procedure, and be able to take oral medication; Aged ≥18 years and ≦75 years;
Eligible patients of reproductive potential (both sexes) must agree to use a reliable method of birth control before enrollment, during the study period and for at least 30 days after their last dose of study therapy;

Who cannot join

Having treated by Her-Target therapy, i.e. erlotinib, gefitinib, cetuximab, trastuzumab;
Having treated by any systemic anti-tumor therapy of NSCLC, including cytotoxic therapy, target medication treatment (i.e. monoclonal antibody), investigational therapy;
Having local radiotherapy of NSCLC; Upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
The findings in radical operation are lymph nodes with extracapsular invasion, or fusion, or all of dissection lymph nodes positive by pathology;
Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival,cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);
Confirmed recurrent cancer by Clinical objective evidence (pathology or radiography images) before the study adjuvant therapy;

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Known hypersensitivity to platinum, Vinorelbine, EGFR-TKI agents or relevant components in the formulation;
Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;
Active interstitial lung disease (ILD) by any clinical evidence; patients with any co-morbidities, or motalic disorders, or any abnormal findings in physical examination or laboratory tests are suspected to have contraindication of study therapy or high risk of study treatment complications;
Any unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, angina starting in latest 3 months, Congestive heart failure (NYHA ≥ II), myocardial infarction within 6 months prior enrollment, under medication treatment of severe arrhythmia, liver, renal or metabolic disease;
know HIV infection Pregnant or breastfeeding women;
ECOG PS ≥2;
Mixed with small cell lung cancer;
Other conditions investigators evaluate that patient is not eligible to this study.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

China15 sites

Beijing Cancer Hospital
Beijing
Chinese PLA General Hospital
Beijing
The second people's hospital of Sichuan
Chengdu
Fujian Medical University Union Hospital
Fuzhou
Sun Yat-Sen University Cancer Center
Guangzhou
Zhejiang Cancer Hospital
Hangzhou
The third affiliated hospital of Harbin Medical Univer
Harbin
The affiliated hospital of medical college Qingdao University
Qingdao
Fudan University Shanghai Cancer Center
Shanghai
Zhongshan Hospital Fudan University
Shanghai
Liaoning Cancer Hospital & Institute
Shenyang
Hebei Provincial Tumor Hospital
Shijiazhuang
The first affiliated hospital of Soochow University
Suzhou
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
The fourth military medical university，Tangdu Hospital
Xi'an

Other trials in China

About this study

Official title: A Prospective, Open-labelled, Randomized, Multicenter Phase II Study to Evaluate Efficacy and Safety of Erlotinib vs NP Chemotherapy as Adjuvant Therapy in Post Radical Operation NSCLC Patients With EGFR19 or 21 Exon Mutation

Conditions: Non-small Cell Lung Cancer Stage III
Being tested: Erlotinib, cis-platinum, Vinorelbine
Keywords: Erlotinib, adjuvant therapy, radical operation, IIIA NSCLC, EGFR mutation
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.

ErlotinibDrug
cis-platinumDrug
VinorelbineDrug

Study groups in NCT01683175
Study group	Role	What they receive
Arm 1	Experimental	Erlotinib 150mg daily oral up to 2 years Receives: Drug: Erlotinib
Arm 2	Active comparator	NP Chemotherapy for 4 cycles Receives: Drug: cis-platinum; Drug: Vinorelbine

What is being measured

The primary outcome is the main question the study is designed to answer.

2-year disease free survival rate (DFSR)
2-year disease free survival rate is defined as the estimation percentage of disease free survival patients with study treatment at 2-year.
Measured: 2 years

Secondary outcomes (5)

disease free survival
Disease free survival is defined as the time from randomization to disease recurrence or death which comes first.
Measured: 5 years
overall survival (OS)
Overall survival is defined as the time from randomization to death.
Measured: 5 years
Quality of Life
The score of Functional Assessment of Cancer Therapy - Lung (FACT-L) subscale and Lung Cancer Symptom Scale (LCSS)
Measured: 5 years
Adverse Event (AE)
frequency of Adverse Event
Measured: 5 years
Serious Adverse Event (SAE)
Frequency of Serious Adverse Event (SAE)
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Oct 2020

First posted11 Sep 2012 (estimated)
Study startAug 2012
Primary completionOct 2020 (estimated)
Study completionOct 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)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.
More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01683175
Sponsor's protocol ID: ML28280
Status last verified: Oct 2016
First submitted: 30 Aug 2012
Last updated: 20 Oct 2016
Results posted: No
Data monitoring committee: No

Publications

Occhipinti M, Imbimbo M, Ferrara R, Simeon V, Fiscon G, Marchal C, Skoetz N, Viscardi G. Adjuvant epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) for the treatment of people with resected stage I to III non-small-cell lung cancer and EGFR mutation. Cochrane Database Syst Rev. 2025 May 27;5(5):CD015140. doi: 10.1002/14651858.CD015140.pub2.
PubMed 40421698
Yue D, Xu S, Wang Q, Li X, Shen Y, Zhao H, Chen C, Mao W, Liu W, Liu J, Zhang L, Ma H, Li Q, Yang Y, Liu Y, Chen H, Zhang Z, Zhang B, Wang C. Updated Overall Survival and Exploratory Analysis From Randomized, Phase II EVAN Study of Erlotinib Versus Vinorelbine Plus Cisplatin Adjuvant Therapy in Stage IIIA Epidermal Growth Factor Receptor+ Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Dec 1;40(34):3912-3917. doi: 10.1200/JCO.22.00428. Epub 2022 Aug 26.
PubMed 36027483
Yue D, Xu S, Wang Q, Li X, Shen Y, Zhao H, Chen C, Mao W, Liu W, Liu J, Zhang L, Ma H, Li Q, Yang Y, Liu Y, Chen H, Wang C. Erlotinib versus vinorelbine plus cisplatin as adjuvant therapy in Chinese patients with stage IIIA EGFR mutation-positive non-small-cell lung cancer (EVAN): a randomised, open-label, phase 2 trial. Lancet Respir Med. 2018 Nov;6(11):863-873. doi: 10.1016/S2213-2600(18)30277-7. Epub 2018 Aug 24.
PubMed 30150014

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Open-labelled, Randomized, Multicenter Phase II Study to Evaluate Efficacy and Safety of Erlotinib vs NP Chemotherapy as Adjuvant Therapy in Post Radical Operation NSCLC Patients With EGFR19 or 21 Exon Mutation
ClinicalTrials.gov ID: NCT01683175
Acronym / sponsor ID: ML28280
Conditions: Non-small Cell Lung Cancer Stage III
Keywords: Erlotinib, adjuvant therapy, radical operation, IIIA NSCLC, EGFR mutation
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 94 participants (actual)
Lead sponsor: Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
Collaborators: Roche Pharma AG
Study start: Aug 2012
Primary completion: Oct 2020 (estimated)
Study completion: Oct 2020 (estimated)
First posted: 11 Sep 2012 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm 1	Experimental	Drug: ErlotinibErlotinib 150mg daily oral up to 2 years
Arm 2	Active comparator	Drug: cis-platinum, Drug: VinorelbineNP Chemotherapy for 4 cycles

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

IIIA NSCLC patients according to TMN-staging of Lung Staging Standard version 7 2009, confirmed by histopathology or cytology after radical operation, and having EGFR exon 19 deletion mutation or exon 21 L858R single base substitution;
Accept study adjuvant therapy within 6 weeks post radical operation;
ECOP PS 0-1; Life expectancy ≥12 weeks;
Hematology: absolute neutrophil count (ANC) ≥1.5×10^9/L; platelet count ≥100×10^9/L; hemoglobin concentration ≥ 9.0 g/dL (permit to maintain hematologic criteria by blood transfusion);
Liver Function: TBil ≤1.5xULN; ALT and AST ≤2.5xULN;

Key exclusion criteria (14 listed)

Having treated by Her-Target therapy, i.e. erlotinib, gefitinib, cetuximab, trastuzumab;
Having treated by any systemic anti-tumor therapy of NSCLC, including cytotoxic therapy, target medication treatment (i.e. monoclonal antibody), investigational therapy;
Having local radiotherapy of NSCLC; Upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
The findings in radical operation are lymph nodes with extracapsular invasion, or fusion, or all of dissection lymph nodes positive by pathology;
Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival,cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);

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
Erlotinib	Drug	Arm 1
cis-platinum	Drug	Arm 2
Vinorelbine	Drug	Arm 2

Primary outcome

2-year disease free survival rate (DFSR)
Time frame: 2 years
2-year disease free survival rate is defined as the estimation percentage of disease free survival patients with study treatment at 2-year.

5 secondary outcomes

disease free survival
Time frame: 5 years
overall survival (OS)
Time frame: 5 years
Quality of Life
Time frame: 5 years
Adverse Event (AE)
Time frame: 5 years
Serious Adverse Event (SAE)
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 20 Oct 2016.
Derived from this study: PubMed 40421698Occhipinti M, Imbimbo M, Ferrara R, Simeon V, Fiscon G, Marchal C, Skoetz N, Viscardi G. Adjuvant epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) for the treatment of people with resected stage I to III non-small-cell lung cancer and EGFR mutation. Cochrane Database Syst Rev. 2025 May 27;5(5):CD015140. doi: 10.1002/14651858.CD015140.pub2.
Derived from this study: PubMed 36027483Yue D, Xu S, Wang Q, Li X, Shen Y, Zhao H, Chen C, Mao W, Liu W, Liu J, Zhang L, Ma H, Li Q, Yang Y, Liu Y, Chen H, Zhang Z, Zhang B, Wang C. Updated Overall Survival and Exploratory Analysis From Randomized, Phase II EVAN Study of Erlotinib Versus Vinorelbine Plus Cisplatin Adjuvant Therapy in Stage IIIA Epidermal Growth Factor Receptor+ Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Dec 1;40(34):3912-3917. doi: 10.1200/JCO.22.00428. Epub 2022 Aug 26.
Derived from this study: PubMed 30150014Yue D, Xu S, Wang Q, Li X, Shen Y, Zhao H, Chen C, Mao W, Liu W, Liu J, Zhang L, Ma H, Li Q, Yang Y, Liu Y, Chen H, Wang C. Erlotinib versus vinorelbine plus cisplatin as adjuvant therapy in Chinese patients with stage IIIA EGFR mutation-positive non-small-cell lung cancer (EVAN): a randomised, open-label, phase 2 trial. Lancet Respir Med. 2018 Nov;6(11):863-873. doi: 10.1016/S2213-2600(18)30277-7. Epub 2018 Aug 24.

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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.

Changli Wang principal investigator

Tianjin Medical University Cancer Institute and Hospital

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 14 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 20 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. 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?

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?

2-year disease free survival rate (DFSR) (time frame: 2 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 NCT01683175, which also lists 3 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 20 Oct 2016.