Induction Erlotinib Therapy in Stage III A (N2) Non-Small Cell Lung Cancer (NSCLC)

NCT ID: NCT00600587

Last Updated: 2013-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2013-06-30

Brief Summary

The purpose of this study is to evaluate the value of induction Erlotinib therapy before thoracotomy or radiotherapy in ⅢA-N2 (confirmed by mediastinoscopy or PET) non-small cell lung cancer (NSCLC) selected by epidermal growth factor receptor (EGFR) gene analysis and initial to explore a new treatment strategy for ⅢA-N2 NSCLC.

Detailed Description

Stage IIIA non-small-cell lung cancer (NSCLC) is seen in a relatively heterogeneous group of patients with ipsilateral mediastinal (N2) lymph node involvement. The relative roles of different treatment modalities are not clear. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) may result in dramatic responses in patients with pulmonary adenocarcinoma carrying EGFR activating mutations. In case reports, the efficacy of perioperative EGFR-TKI therapy in patients with locally advanced NSCLC harboring EGFR gene mutations was satisfactory. Although no prospective data support the use of EGFR-TKIs as induction therapy in stage IIIA-N2 NSCLC, their low toxicity profile and the possibility of a rapid tumor response suggests that prospective trials are required. Therefore, this study evaluated the value of induction erlotinib therapy in IIIA-N2 NSCLC selected by EGFR gene analysis and explored a new treatment strategy for this subset. Erlotinib specifically targets the EGFR TK domain, which is highly expressed and occasionally mutated in various forms of cancer. It binds in a reversible fashion to the adenosine triphosphate (ATP) binding site of the receptor.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Erlotinib targeted NSCLC population based on EGFR gene analysis(EGFR gene status: activating mutation)

Group Type: EXPERIMENTAL

neoadjuvant erlotinib therapy

Intervention Type: DRUG

150mg erlotinib taken once daily and continued uninterrupted for 42 days before evaluation/thoracotomy/radiotherapy.

B

Non-erlotinib targeted NSCLC population based on EGFR gene analysis

Group Type: ACTIVE_COMPARATOR

neoadjuvant gemcitabine/carboplatin therapy

Intervention Type: DRUG

3 cycles of neoadjuvant gemcitabine(1250mg/m2,d1,d8)/carboplatin(AUC=5,day1) chemotherapy before evaluation/thoracotomy/radiotherapy.

Interventions

neoadjuvant erlotinib therapy

150mg erlotinib taken once daily and continued uninterrupted for 42 days before evaluation/thoracotomy/radiotherapy.

Intervention Type: DRUG

neoadjuvant gemcitabine/carboplatin therapy

3 cycles of neoadjuvant gemcitabine(1250mg/m2,d1,d8)/carboplatin(AUC=5,day1) chemotherapy before evaluation/thoracotomy/radiotherapy.

Intervention Type: DRUG

Other Intervention Names

tarceva; gemzar

Eligibility Criteria

Inclusion Criteria

• Written informed consent
• Histological or cytological documented
• Resectable NSCLC of stage IIIA-N2 confirmed by mediastinoscopy or PET
• Naive therapy NSCLC
• Candidates should be tolerated with induction therapy and thoracotomy with ECOG performance status 0-2, adequate haematological and Hepatic- renal function and qualified lung function
• Enough tissue samples to perform gene analysis

Exclusion Criteria

• Small cell lung cancer
• Pregnant or breast-feeding women
• Any unstable systemic disease
• Patients with exposure to investigational drug therapy or other concurrent anticancer therapy outside of this trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wen-zhao ZHONG

Guangdong General Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yi-long WU, MD

Role: PRINCIPAL_INVESTIGATOR

Guangdong Lung Cancer Institute, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Sciences

Xue-ning YANG, MD

Role: STUDY_CHAIR

Guangdong Lung Cancer Institute, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Sciences

Wen-zhao ZHONG, MD

Role: STUDY_DIRECTOR

Guangdong Lung Cancer Institute, Guangdong Lung Cancer Institute, Guangdong Academy of Medical Sciences

Locations

Guangdong General Hospital

Guangzhou, Guangdong, China

Countries

China

References

Wu YL, Zhong WZ, Li LY, Zhang XT, Zhang L, Zhou CC, Liu W, Jiang B, Mu XL, Lin JY, Zhou Q, Xu CR, Wang Z, Zhang GC, Mok T. Epidermal growth factor receptor mutations and their correlation with gefitinib therapy in patients with non-small cell lung cancer: a meta-analysis based on updated individual patient data from six medical centers in mainland China. J Thorac Oncol. 2007 May;2(5):430-9. doi: 10.1097/01.JTO.0000268677.87496.4c.

Reference Type: BACKGROUND

PMID: 17473659 (View on PubMed)

Costa DB, Kobayashi S, Tenen DG, Huberman MS. Pooled analysis of the prospective trials of gefitinib monotherapy for EGFR-mutant non-small cell lung cancers. Lung Cancer. 2007 Oct;58(1):95-103. doi: 10.1016/j.lungcan.2007.05.017. Epub 2007 Jul 3.

Reference Type: BACKGROUND

PMID: 17610986 (View on PubMed)

Takamochi K, Suzuki K, Sugimura H, Funai K, Mori H, Bashar AH, Kazui T. Surgical resection after gefitinib treatment in patients with lung adenocarcinoma harboring epidermal growth factor receptor gene mutation. Lung Cancer. 2007 Oct;58(1):149-55. doi: 10.1016/j.lungcan.2007.04.016. Epub 2007 Jun 4.

Reference Type: BACKGROUND

PMID: 17548126 (View on PubMed)

Kappers I, Klomp HM, Burgers JA, Van Zandwijk N, Haas RL, van Pel R. Neoadjuvant (induction) erlotinib response in stage IIIA non-small-cell lung cancer. J Clin Oncol. 2008 Sep 1;26(25):4205-7. doi: 10.1200/JCO.2008.16.3709. No abstract available.

Reference Type: BACKGROUND

PMID: 18757336 (View on PubMed)

Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, Sunpaweravong P, Han B, Margono B, Ichinose Y, Nishiwaki Y, Ohe Y, Yang JJ, Chewaskulyong B, Jiang H, Duffield EL, Watkins CL, Armour AA, Fukuoka M. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009 Sep 3;361(10):947-57. doi: 10.1056/NEJMoa0810699. Epub 2009 Aug 19.

Reference Type: BACKGROUND

PMID: 19692680 (View on PubMed)

Robinson LA, Wagner H Jr, Ruckdeschel JC; American College of Chest Physicians. Treatment of stage IIIA non-small cell lung cancer. Chest. 2003 Jan;123(1 Suppl):202S-220S. doi: 10.1378/chest.123.1_suppl.202s.

Reference Type: BACKGROUND

PMID: 12527580 (View on PubMed)

Zhong W, Yang X, Yan H, Zhang X, Su J, Chen Z, Liao R, Nie Q, Dong S, Zhou Q, Yang J, Tu H, Wu YL. Phase II study of biomarker-guided neoadjuvant treatment strategy for IIIA-N2 non-small cell lung cancer based on epidermal growth factor receptor mutation status. J Hematol Oncol. 2015 May 17;8:54. doi: 10.1186/s13045-015-0151-3.

Reference Type: DERIVED

PMID: 25981169 (View on PubMed)

Other Identifiers

tarceva-123456-1

Identifier Type: -

Identifier Source: secondary_id

CSLC-0702

Identifier Type: -

Identifier Source: org_study_id