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

NCT00600587 | Completed Phase 2 DMC

• 2 other identifiers: CSLC-0702tarceva-123456-1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Carcinoma, Non-Small-Cell Lung; Genes, erbB-1; tyrosine kinase inhibitor; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• Response to Neoadjuvant Erlotinib Therapy

  a week after completion of the induction erlotinib therapy

Secondary Outcomes (4)

• disease free survival

  every 3 months

• overall survival

  every 3 months

• complete resection rate

  7 days after thoractomy

• Toxicity of Neoadjuvant Erlotinib Therapy and postoperative complications

  one months after thoractomy

Study Arms (2)

A

EXPERIMENTAL

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

Drug: neoadjuvant erlotinib therapy

B

ACTIVE COMPARATOR

Non-erlotinib targeted NSCLC population based on EGFR gene analysis

Drug: neoadjuvant gemcitabine/carboplatin therapy

Interventions

neoadjuvant erlotinib therapy DRUG

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

Also known as: tarceva

A

neoadjuvant gemcitabine/carboplatin therapy DRUG

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

Also known as: gemzar

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

Related Publications (7)

• 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.

  PMID: 17473659 BACKGROUND

• 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.

  PMID: 17610986 BACKGROUND

• 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.

  PMID: 17548126 BACKGROUND

• 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.

  PMID: 18757336 BACKGROUND

• 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.

  PMID: 19692680 BACKGROUND

• 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.

  PMID: 12527580 BACKGROUND

• 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.

  PMID: 25981169 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Yi-long WU, MD

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

  PRINCIPAL INVESTIGATOR

• Xue-ning YANG, MD

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

  STUDY CHAIR

• Wen-zhao ZHONG, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guangdong General Hospital

Study Record Dates

• First Submitted: January 14, 2008
• First Posted: January 25, 2008
• Study Start: September 1, 2007
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 25, 2013

Record last verified: 2013-06

Locations

CN (1)