Development and Clinical Validation of Early-stage Lung Cancer Prognostic Kit

Lung Cancer Clinical Trial

Official title:

Development and Clinical Validation of Early-stage Lung Cancer Prognostic Kit and Immunotherapy Companion Diagnostic Laboratory Developed Tests

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05557474
• Other study ID #: 110WFD2510303
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: December 31, 2028

Study information

• Verified date: December 2023
• Source: Chung Shan Medical University
• Contact: GeeChen Chang, MD. PhD
• Phone: +886-4-24739595
• Email: geechen[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Lung cancer is the leading cause of cancer mortality worldwide in spite of the advanced progresses in medication and low-dose CT screening. The early-stage lung cancer accounts for less than 50% of newly diagnosed lung cancer in Taiwan, even in stage IB patients proximately 30% still suffer from recurrence and metastasis. The International Cancer Moonshot Project recently established the first comprehensive proteogenomics profiling of early-stage lung cancer patients in East Asia, revealing a proteomics-informed classification to identify a new "late like" subtype, which can identify a subgroup of early-stage patients with worse clinicopathological features (Cell, Cover story, 2020). This study has been featured in prestigious journals (Nat Rev Clin Oncol; Cancer Discov, 2020) and led to two provisional US patents. In this proposal, taking the discovery from the Cancer Moonshot multiomics database, the investigators aim to translate these findings into clinical utilities. Two subprojects are proposed. (1) Validation of "late-like" protein markers for identifying high-risk early-stage lung cancer: Two IVD kits will be developed, including high-risk early-stage lung cancer IHC prediction kit for tumor staining and high-risk early lung cancer ELISA prediction kit for noninvasive diagnosis. (2) Conducting a prospective clinical trial to evaluate the accuracy of high-risk early-stage lung cancer IHC prediction kit and high-risk early-stage lung cancer ELISA prediction kit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 236
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Willing to sign and provide subject consent.
• Male or female of age 20 or older.
• Patients diagnosed with lung adenocarcinoma by tumor pathology.
• Lung cancer with the pathological stage of IA/IB/II/IIIA according to the American Joint Committee on Cancer Staging Manual (8th Edition).
• Complete tumor resection (R0 resection).
• The East Coast Cancer Clinical Research Collaborative (ECOG) performance status was 0 or 1 at the time of grouping.
• Those willing to provide tumor tissue or cytology specimens (including surgical specimens, tissue biopsy specimens, or cytology specimens), blood and body fluid specimens (for follow-up or disease recurrence, such as urine, malignant pleural effusion, ascites, pericardial fluid, etc.).

Exclusion Criteria:

• Not primary lung cancer patients.
• Lung cancer patients whose pathological stage is not IA/IB/II/IIIA according to the American Joint Committee on Cancer Staging Manual (8th Edition) after surgery.
• Patients with uncontrolled malignant tumors other than lung cancer.
• Uncontrolled systemic disease (such as diabetes, hypertension, active infection, etc.) (determined by the principal investigator )
• Pregnant women.
• Any condition may put the patient at serious risk, may affect the interpretation of the trial results, or may seriously interfere with the patient's participation in the trial.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Recurrence
• Surgery

Intervention

Other:
• Early-stage lung cancer prognostic kit -- ELISA
blood sample with ELISA
• Early-stage lung cancer prognostic kit -- IHC
surgical tumor part with IHC

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	National Taiwan University, Cancer Center	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Chung Shan Medical University	National Science and Technology Council

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Chen YJ, Roumeliotis TI, Chang YH, Chen CT, Han CL, Lin MH, Chen HW, Chang GC, Chang YL, Wu CT, Lin MW, Hsieh MS, Wang YT, Chen YR, Jonassen I, Ghavidel FZ, Lin ZS, Lin KT, Chen CW, Sheu PY, Hung CT, Huang KC, Yang HC, Lin PY, Yen TC, Lin YW, Wang JH, Rag — View Citation

Galon J, Bruni D. Tumor Immunology and Tumor Evolution: Intertwined Histories. Immunity. 2020 Jan 14;52(1):55-81. doi: 10.1016/j.immuni.2019.12.018. — View Citation

Jamal-Hanjani M, Wilson GA, McGranahan N, Birkbak NJ, Watkins TBK, Veeriah S, Shafi S, Johnson DH, Mitter R, Rosenthal R, Salm M, Horswell S, Escudero M, Matthews N, Rowan A, Chambers T, Moore DA, Turajlic S, Xu H, Lee SM, Forster MD, Ahmad T, Hiley CT, A — View Citation

Yarchoan M, Johnson BA 3rd, Lutz ER, Laheru DA, Jaffee EM. Targeting neoantigens to augment antitumour immunity. Nat Rev Cancer. 2017 Apr;17(4):209-222. doi: 10.1038/nrc.2016.154. Epub 2017 Feb 24. Erratum In: Nat Rev Cancer. 2017 Aug 24;17 (9):569. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival	Disease free survival	5 years
Secondary	Overall survival		10 years