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Circulating Tumor DNA (ctDNA) as a Prognostic Tool in Patients With Advanced Lung Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT03090815
Recruitment Status : Unknown
Verified March 2017 by Dr. David Chi-leung Lam, The University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Sponsor:
Collaborator:
Feinstein Institute for Medical Research
Information provided by (Responsible Party):
Dr. David Chi-leung Lam, The University of Hong Kong

Study Description
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Brief Summary:

Lung cancer is the leading cause of cancer death in the U.S. and throughout the world. Lung cancers are broadly divided histologically into small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). About 25% of patients with NSCLC have stage I or II disease. The primary treatment modality is surgical resection,2 and 5-year survival rates are 65% for stage I and 41% for stage II disease. However, more than 70% of patients with NSCLC present with stage III or IV disease. Patients with stage III disease are most commonly treated with chemoradiation, and 5-year survival rate is 26%. Chemotherapy and targeted therapy are often used for stage IV disease, which has a 5-year survival rate of 4%.

Tyrosine kinase inhibitor (TKI) is a targeted therapy against specific molecules in critical cell-signaling pathways involved in lung carcinogenesis. The currently available FDA approved TKIs for advanced NSCLC include afatinib, gefitinib, and erlotinib that inhibit epidermal growth factor receptor (EGFR) signaling 6 and crizotinib that inhibits anaplastic lymphoma kinase (ALK) signaling. However, only tumors that carry the corresponding oncogenic mutations (e.g., sensitizing EGFR mutations) would respond well to these TKIs. Meta-analyses of clinical trials evaluating the efficacy of gefitinib and erlotinib have demonstrated that NSCLC patients who are EGFR mutation-positive have a lower risk of disease progression when treated with an EGFR-TKI as compared to those treated with chemotherapy (HR = 0.43, 95% confidence interval, CI=0.38-0.49). EGFR-TKI, however, confers no benefits to patients who are EGFR wildtype (HR = 1.06, 95% CI=0.94-1.19). A phase III trial of crizotinib has also demonstrated the superiority of crizotinib to standard chemotherapy in ALK-positive NSCLC patients (HR = 0.49; 95% CI=0.37-0.64).

In Hong Kong, as in other parts of Asia like in China and in Taiwan, other than the majority of lung cancer patients being smokers, there is also a prominence of non-smokers in lung cancer. Compared with Caucasians, there is also a relatively higher incidence of EGFR mutation in lung adenocarcinomas. The prevalence of EGFR mutation in Asian population with lung adenocarcinomas can reach up to 60% compared to at most 30% in the Caucasian population. These EGFR mutant tumors will demonstrate better response to the drug EGFR-TKI, boosting up the response rate to almost 70% compared to 30% with conventional chemotherapy for lung cancer. Even with this remarkable response, however, EGFR-TKI will eventually fail in EGFR mutant lung cancer. There is an imminent need to look for newer therapeutic targets or agents that can overcome this acquired resistance to anti-cancer drugs and to explore alternative molecular signaling pathways that could interact or enhance EGFR signaling pathways to modulate the therapeutic response in lung cancer.


Condition or disease Intervention/treatment
Adenocarcinoma of Lung (Disorder) Genetic: Sequencing of ctDNA in plasma

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Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Circulating Tumor DNA (ctDNA) as a Prognostic Tool in Patients With Advanced Lung Adenocarcinoma
Study Start Date : February 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patient receiving TKI
Patients are diagnosed with primary adenocarcinoma and have no concurrent cancers and are going to receive TKI
 Genetic: Sequencing of ctDNA in plasma
Sequencing of ctDNA in plasma
Patient receiving ALK-TKI
Patients are diagnosed with primary adenocarcinoma and have no concurrent cancers and are going to receive ALK-TKI
 Genetic: Sequencing of ctDNA in plasma
Sequencing of ctDNA in plasma
Patient receiving chemotherapy
Patients are diagnosed with primary adenocarcinoma and have no concurrent cancers and are going to receive chemotherapy
 Genetic: Sequencing of ctDNA in plasma
Sequencing of ctDNA in plasma


Outcome Measures
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Primary Outcome Measures :
  1. ctDNA mutation [ Time Frame: an average of one year ]
    Types of ctDNA mutations

  2. Any new ctDNA mutations [ Time Frame: an average of one year ]
    Types of new ctDNA mutations


Secondary Outcome Measures :
  1. ctDNA levels [measured as copy number] [ Time Frame: an average of one year ]
    Quantity of ctDNA mutations

  2. Any new ctDNA levels [measured as copy number] [ Time Frame: an average of one year ]
    Quantity of new type ctDNA


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who are admitted to ward or attended to clinic with confirmed advanced lung adenocarcinoma and planning to receive TKI or chemo as first-line therapy, will be invited to consent for the collection of clinical samples and data and follow-up.
Criteria

Inclusion Criteria:

  • Patients are eligible if they (1) are diagnosed with primary adenocarcinoma, (2) have no concurrent cancers, (3) are going to receive TKI or chemo as first-line therapy, and (4) are willing to sign informed consent and enrolled in the study before treatment starts.

Exclusion Criteria:

  • Patients have other concurrent cancers
  • Patients who are not eligible receive TKI or chemo as first-line therapy
  • Patients who are not willing or able to sign informed consent
  • Histology other than adenocarcinoma
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03090815


Locations
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Hong Kong
University of Hong Kong Queen Mary Hospital Recruiting
Hong Kong, Hong Kong, 0
Contact: David CL Lam, BSc,MBBS,PhD,FCCP,FACP,FRCP(E)    (852) 2255 5814    dcllam@hku.hk   
Principal Investigator: David CL Lam, BSc,MBBS,PhD,FCCP,FACP,FRCP(E)         
Sponsors and Collaborators
The University of Hong Kong
Feinstein Institute for Medical Research
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Fast Stats: An interactive tool for access to SEER cancer statistics. Surveillance Research Program, National Cancer Institute, 2013.  This link exits the ClinicalTrials.gov site Leading cancer sites in Hong Kong in 2012. Hospital Authority, 2012.  This link exits the ClinicalTrials.gov site

Publications:
Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.

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Responsible Party: Dr. David Chi-leung Lam, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03090815     History of Changes
Other Study ID Numbers: HKU_UW_16_104
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Keywords provided by Dr. David Chi-leung Lam, The University of Hong Kong:
Circulating Tumor DNA
Prognostic
Molecular tests
Additional relevant MeSH terms:
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Adenocarcinoma
Adenocarcinoma of Lung
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site