Erlotinib Versus Vinorelbine/Cisplatin as Adjuvant Treatment in Stage IIIA NSCLC Patients With EGFR Mutations
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ClinicalTrials.gov Identifier: NCT01410214 |
Recruitment Status : Unknown
Verified December 2011 by Chinese Lung Cancer Surgical Group.
Recruitment status was: Recruiting
First Posted : August 5, 2011
Last Update Posted : December 23, 2011
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Condition or disease | Intervention/treatment | Phase |
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Non-small Cell Lung Cancer Stage IIIA | Drug: Erlotinib Drug: vinorelbine/cisplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Trial of Erlotinib Versus Combination of Vinorelbine Plus Cisplatin as Adjuvant Treatment in Stage IIIA Non-small-cell Lung Cancer After Complete Resection With Sensitizing EGFR Mutation in Exon 19 or 21 and Wild-type K-ras |
Study Start Date : | May 2011 |
Estimated Primary Completion Date : | July 2015 |
Estimated Study Completion Date : | July 2017 |

Arm | Intervention/treatment |
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Experimental: Erlotinib arm
In the adjuvant treatment phase, erlotinib 150 mg/day taken orally for 2 years or till disease progression or unacceptable toxicity.
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Drug: Erlotinib
In the adjuvant treatment phase, erlotinib 150 mg/day taken orally for 2 years or till disease progression or unacceptable toxicity.
Other Name: tarceva |
Active Comparator: Chemo arm
In the adjuvant treatment phase, patient will receive vinorelbine 25mg/m2 IV on day 1 and day 8, and cisplatin 25mg/m2 on day 1 and day 2 and day 3, of a 3-week schedule for 4 cycles or till disease progression or unacceptable toxicity.
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Drug: vinorelbine/cisplatin
In the adjuvant treatment phase, patient will receive vinorelbine 25mg/m2 IV on day 1 and day 8, and cisplatin 25mg/m2 on day 1 and day 2 and day 3, of a 3-week schedule for 4 cycles or till disease progression or unacceptable toxicity.
Other Names:
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- Disease-free survival [ Time Frame: 2 years ]To evaluate Disease-free survival(DFS) of two groups
- Number of Participants with Adverse Events [ Time Frame: 2 years ]To evaluate the safety profile(Number of Participants with Adverse Events) of two group.
- Quality of Life (QOL) [ Time Frame: 2 years ]To evaluate the Quality of Life (QOL) of two group.
- overall survival (OS) [ Time Frame: 2 years ]To evaluate the overall survival (OS) of two groups

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Written informed consent provided.
- Males or females aged ≥18 years.
- Chest CT, brain CT or MRI, ECT, abdominal and double-neck B-, or whole body PET-CT examination in 4 weeks before complete resection.
- Pathological diagnosed of non-small cell lung cancer.
- Diagnosed as stage IIIA.
- In 4 weeks after complete resection pts start to accept the adjuvant therapy in this study, previously did not receive any anti-tumor therapy.
- EGFR activating mutation in exon 19 or 21 and KARS
- ECOG performance status 0-1.
- Life expectancy ≥3 months.
- Adequate hematological function:Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
- Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN);Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN.
- Adequate renal function:Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60 ml/min.
- Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- Patients must be nonpregnant and non-lactating.Patients of childbearing potential must implement an effective method of contraception during the study. All female Patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test. .
Exclusion Criteria:
- Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- Patients with prior chemotherapy or therapy with systemic anti-tumour therapy.
- Patients with prior radiotherapy.
- History of another malignancy in the last 5 years with the exception of the following:Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
- Any evidence confirmed tumor recurrence before adjuvant treatment.
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- Any evidence of clinically active interstitial lung disease.
- Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.
- Known human immunodeficiency virus (HIV) infection.
- Known hypersensitivity to Tarceva or NVB or cisplatin.
- Pregnancy or breast-feeding women.
- ECOG performance status ≥ 2.
- Ingredients mixed with small cell lung cancer patients
- Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410214
Contact: Xuefeng Kan | 13920870123@126.com |
China, Beijing | |
Beijing Cancer Hospital | Recruiting |
Beijing, Beijing, China, 100000 | |
Contact: Chao Lv | |
Principal Investigator: Yue Yang | |
Chinese PLA General Hospital | Not yet recruiting |
Beijing, Beijing, China, 100000 | |
Contact: Tao Wang | |
Principal Investigator: Xiangyang Chu | |
China, Guangdong | |
Sun Yat-Sen University Cancer Center | Not yet recruiting |
Guangzhou, Guangdong, China, 510000 | |
Contact: Lanjun Zhang | |
Principal Investigator: Lanjun Zhang | |
China, Hebei | |
Hebei Medical University Fourth Hospital | Recruiting |
Shijiazhuang, Hebei, China, 050000 | |
Contact: Xinbo Liu | |
Principal Investigator: Junfeng Liu | |
China, Heilongjiang | |
Harbin Medical University Cancer Hospital | Recruiting |
Harbin, Heilongjiang, China, 150000 | |
Contact: Changfa Qu | |
Principal Investigator: Shidong Xu | |
China, Jiangsu | |
The First Affiurted Hospital of Soochow University | Not yet recruiting |
Suzhou, Jiangsu, China, 215000 | |
Contact: Haitao Ma | |
Principal Investigator: Haitao Ma | |
China, Shandong | |
Qingdao University Medical College | Not yet recruiting |
Qingdao, Shandong, China, 266000 | |
Contact: Yongjie Wang | |
Principal Investigator: Yi Shen | |
China, Shanghai | |
Fudan University Shanghai Cancer Center | Not yet recruiting |
Shanghai, Shanghai, China, 200000 | |
Contact: Yihua Sun | |
Principal Investigator: Haiquan Chen | |
China, Sichuang | |
The Second People's Hospital of Sichuan | Recruiting |
Chengdu, Sichuang, China, 610000 | |
Contact: Qiang Li | |
Principal Investigator: Qiang Li | |
China, Tianji | |
Tianjin Medical University Cancer Institute and Hospital | Recruiting |
Tianji, Tianji, China, 300000 | |
Contact: Xuefeng Kan | |
Principal Investigator: Changli Wang | |
China, Zhejiang | |
Zhejiang Cancer Hospital | Not yet recruiting |
Hangzhou, Zhejiang, China, 310000 | |
Contact: Xinming Zhou | |
Principal Investigator: Weimin Mao |
Principal Investigator: | Changli Wang | Tianjin Medical University Cancer Institute and Hospital |
Responsible Party: | Chinese Lung Cancer Surgical Group |
ClinicalTrials.gov Identifier: | NCT01410214 |
Other Study ID Numbers: |
C-LCSG-001 |
First Posted: | August 5, 2011 Key Record Dates |
Last Update Posted: | December 23, 2011 |
Last Verified: | December 2011 |
NSCLC EGFR Mutation Positive complete resection Erlotinib Versus NVB/Cisplatin as Adjuvant treatment |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Cisplatin |
Erlotinib Hydrochloride Vinorelbine Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |