NCT04025515

Brief Summary

In this study, the investigators plan to undertake comprehensive molecular profiling of "actionable" alterations in lung cancer specimens in order to determine the prevalence of each genetic subtype in the local population.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
6 countries

10 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Jan 2019Dec 2026

Study Start

First participant enrolled

January 11, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2026

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

8 years

First QC Date

June 15, 2019

Last Update Submit

May 7, 2026

Conditions

Lung CancerNon-Small Cell Lung Cancer

Keywords

Oncomine Focus Panel AssayMolecular profilingTargeted therapiesDriver oncogeneNext-Generation Sequencing (NGS)PD-L1 Immunohistochemistry (IHC, Dako 22C3)HotspotsSingle Nucleotide Variants (SNVs)Insertions/ Deletions (Indels)Copy Number Variation (CNVs),Gene FusionsFormalin-FixedParaffin Embedded (FFPE) extracted DNA and RNAIon PGM™ SystemOncomine™ Comprehensive Assay v3

Outcome Measures

Primary Outcomes (1)

  • Molecular profiling of lung cancer specimens

    Lung cancer specimens will be collected and profiled at a molecular level to evaluate the molecular epidemiology of NSCLC in Asia

    After patient meets the eligibility criteria and consent has been taken

Secondary Outcomes (3)

  • Collection of patient survival status

    After molecular profiling has been completed, every few months up to 2 years

  • Collection of subsequent patient treatment status

    After molecular profiling has been completed, every few months up to 2 years

  • Collection of the clinical outcomes of the subsequent treatments the patients receive

    After molecular profiling has been completed, every few months up to 2 years

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Asian patients with Non-Small Cell Lung Cancer (NSCLC)

You may qualify if:

  • The availability of sufficient archival tumor tissue specimen (15 slides of 4 microns per section)
  • Age ≥ 21 years
  • WHO performance status ≤ 2
  • Life expectancy of ≥ 12 weeks
  • Patients should have adequate organ function for potential consideration into clinical trials (routine blood tests are valid within 14 days before enrollment):
  • Adequate bone marrow function as shown by: ANC ≥ 1.0 x 10\^9/L, Platelets ≥ 75 x 10\^9/L, Hb ≥ 7.5 g/dL
  • Alanine aminotransferase (ALT) and aspirate aminotransferase (AST) normal range (or ≤3.0 x ULN if liver metastases are present)
  • Willing to provide signed informed consent
  • Patients whom do not fulfill the above criteria may be discussed on a case-by-case basis with the study team, for potential enrolment

You may not qualify if:

  • \- No more than 3 lines of cytotoxic chemotherapy at the time of enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

The Brunei Cancer Centre

Brunei, Brunei

Location

Hong Kong Integrated Oncology Centre

Hong Kong, Hong Kong

Location

The Chinese University of Hong Kong, Department of Clinical Oncology

Hong Kong, Hong Kong

Location

Rajiv Ghandhi Cancer Institute and Research Centre

New Delhi, India

Location

Penang Adventist Hospital

George Town, Malaysia

Location

Pantai Hospital, Kuala Lumpur

Kuala Lumpur, Malaysia

Location

University Malaya Medical Centre, Clinical Oncology Department

Kuala Lumpur, Malaysia

Location

Beacon Hospital

Petaling Jaya, Malaysia

Location

National Cancer Centre Singapore

Singapore, Singapore

Location

Phramongkutklao Hospital

Bangkok, Thailand

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

15 unstained FFPE slides of 4 microns per section

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Daniel Tan, BSc, MBBS, MRCP

    National Cancer Centre, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2019

First Posted

July 19, 2019

Study Start

January 11, 2019

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

December 25, 2026

Last Updated

May 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

HK(2)MY(4)BR(1)TH(1)SG(1)IN(1)