Non-small Cell Lung Cancer Stage IIIAPhase 2NCT01410214
Erlotinib Versus Vinorelbine/Cisplatin as Adjuvant Treatment in Stage IIIA NSCLC Patients With EGFR Mutations
A Phase 2 study testing Erlotinib and vinorelbine/cisplatin in people with Non-small Cell Lung Cancer Stage IIIA, run by Chinese Lung Cancer Surgical Group at 11 sites in China.
Trial summary
The purpose of this study is to assess the effect and safety of erlotinib versus NVB plus cisplatin (NP) as adjuvant treatment in patients with stage IIIA NSCLC after complete resection with EGFR activating mutations and to explore a new treatment strategy for this subset. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-small Cell Lung Cancer Stage IIIA
- What is being tested?
- 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
- 80 participants
- Where
- 11 sitesChina
- Study dates
- May 2011to Jul 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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. .
Who cannot join
- 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).
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- 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.
Trial locations and contacts
11 sites in 1 country.
Xuefeng Kan contact
11 sites in 1 country
China11 sites, 11 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100000
Chao Lv
Yue Yang
- Not yet recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100000
Tao Wang
Xiangyang Chu
- Recruiting
The Second People's Hospital of Sichuan
Chengdu, Sichuang, 610000
Qiang Li
Qiang Li
- Not yet recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510000
Lanjun Zhang
Lanjun Zhang
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Xinming Zhou
Weimin Mao
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
Changfa Qu
Shidong Xu
- Not yet recruiting
Qingdao University Medical College
Qingdao, Shandong, 266000
Yongjie Wang
Yi Shen
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
Yihua Sun
Haiquan Chen
- Recruiting
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, 050000
Xinbo Liu
Junfeng Liu
- Not yet recruiting
The First Affiurted Hospital of Soochow University
Suzhou, Jiangsu, 215000
Haitao Ma
Haitao Ma
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianji, Tianji, 300000
Xuefeng Kan
Changli Wang
About this study
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
The purpose of this study is to assess the effect and safety of erlotinib versus NVB plus cisplatin (NP) as adjuvant treatment in patients with stage IIIA NSCLC after complete resection with EGFR activating mutations and to explore a new treatment strategy for this subset.
Read the detailed description
The LACE meta-analysis identified four cycles of platinum-based program to improve II~IIIA stage completely resected NSCLC pts the role of 5-year survival, but its treatment-related life threatening toxicity limits its use. The EGFR tyrosine kinase inhibitor (TKI) may provide a dramatic response in pts with pulmonary adenocarcinoma carrying EGFR activating mutations in the metastatic setting. The aim of this study is to investigate the efficacy and safety of erlotinib versus NVB plus cisplatin (NP) as adjuvant treatment in pts with stage IIIA NSCLC after Complete Resection with EGFR activating mutations and to explore a new treatment strategy for this subset.
- Conditions
- Non-small Cell Lung Cancer Stage IIIA
- Being tested
- Erlotinib, vinorelbine/cisplatin
- Keywords
- NSCLC, EGFR Mutation Positive, complete resection, Erlotinib Versus NVB/Cisplatin as Adjuvant treatment
- 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
Also called tarceva
In the adjuvant treatment phase, erlotinib 150 mg/day taken orally for 2 years or till disease progression or unacceptable toxicity.
vinorelbine/cisplatinDrug
Also called NP, NVB/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.
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib arm | Experimental | In the adjuvant treatment phase, erlotinib 150 mg/day taken orally for 2 years or till disease progression or unacceptable toxicity. Receives: Drug: Erlotinib |
| Chemo arm | Active comparator | 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. Receives: Drug: vinorelbine/cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
To evaluate Disease-free survival(DFS) of two groups
Measured: 2 years
Secondary outcomes (3)
Number of Participants with Adverse Events
To evaluate the safety profile(Number of Participants with Adverse Events) of two group.
Measured: 2 years
Quality of Life (QOL)
To evaluate the Quality of Life (QOL) of two group.
Measured: 2 years
overall survival (OS)
To evaluate the overall survival (OS) of two groups
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2015 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer Stage IIIAStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Lung Cancer Surgical Group
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital, Fudan University, Zhejiang Cancer Hospital, Peking University Cancer Hospital & Institute, Sun Yat-sen University, Chinese PLA General Hospital, Qingdao University, The First Affiliated Hospital of Soochow University, The Second Affiliated Hospital of Harbin Medical University, Hebei Medical University Fourth Hospital, The Second People's Hospital of Sichuan
- Responsible party
- Sponsor
- Investigators
- Changli Wang, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410214
- Sponsor's protocol ID
- C-LCSG-001
- Status last verified
- Dec 2011
- First submitted
- 1 Aug 2011
- Last updated
- 23 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01410214
- Acronym / sponsor ID
- C-LCSG-001
- Conditions
- Non-small Cell Lung Cancer Stage IIIA
- Keywords
- NSCLC, EGFR Mutation Positive, complete resection, Erlotinib Versus NVB/Cisplatin as Adjuvant treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chinese Lung Cancer Surgical GroupUniversity, hospital or other
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital, Fudan University, Zhejiang Cancer Hospital, Peking University Cancer Hospital & Institute, Sun Yat-sen University, Chinese PLA General Hospital, Qingdao University, The First Affiliated Hospital of Soochow University, The Second Affiliated Hospital of Harbin Medical University, Hebei Medical University Fourth Hospital, The Second People's Hospital of Sichuan
- Study start
- May 2011
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 5 Aug 2011 (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.
The purpose of this study is to assess the effect and safety of erlotinib versus NVB plus cisplatin (NP) as adjuvant treatment in patients with stage IIIA NSCLC after complete resection with EGFR activating mutations and to explore a new treatment strategy for this subset.
Detailed description
The LACE meta-analysis identified four cycles of platinum-based program to improve II~IIIA stage completely resected NSCLC pts the role of 5-year survival, but its treatment-related life threatening toxicity limits its use. The EGFR tyrosine kinase inhibitor (TKI) may provide a dramatic response in pts with pulmonary adenocarcinoma carrying EGFR activating mutations in the metastatic setting. The aim of this study is to investigate the efficacy and safety of erlotinib versus NVB plus cisplatin (NP) as adjuvant treatment in pts with stage IIIA NSCLC after Complete Resection with EGFR activating mutations and to explore a new treatment strategy for this subset.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erlotinib arm | Experimental | Drug: ErlotinibIn the adjuvant treatment phase, erlotinib 150 mg/day taken orally for 2 years or till disease progression or unacceptable toxicity. |
| Chemo arm | Active comparator | Drug: vinorelbine/cisplatinIn 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| ErlotinibAlso: tarcevaIn the adjuvant treatment phase, erlotinib 150 mg/day taken orally for 2 years or till disease progression or unacceptable toxicity. | Drug | Erlotinib arm |
| vinorelbine/cisplatinAlso: NP, NVB/cisplatinIn 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. | Drug | Chemo arm |
Primary outcome
Disease-free survival
Time frame: 2 years
To evaluate Disease-free survival(DFS) of two groups
3 secondary outcomes
Number of Participants with Adverse Events
Time frame: 2 years
Quality of Life (QOL)
Time frame: 2 years
overall survival (OS)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2011.
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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.
Xuefeng Kan contact
Changli Wang principal investigator
Tianjin Medical University Cancer Institute and Hospital
11 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 Erlotinib and vinorelbine/cisplatin in people with Non-small Cell Lung Cancer Stage IIIA, run by Chinese Lung Cancer Surgical Group at 11 sites in China.
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 14 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 23 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Contact Xuefeng Kan (13920870123@126.com), 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: 2 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 23 Dec 2011.