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NCT Number: NCT05872763

A Study of Participants in China With Non-Small-Cell Lung Cancer That is Unable to be Treated With Surgery

This is a multicenter, observational cohort study in China with both primary prospective data collection and retrospective collection of prior treatment information from medical records, which enrolls and follows patients who are newly diagnosed with unresectable stage IIIB/IIIC/IV Non-Small-Cell Lung Cancer (NSCLC) in the selected sites.

This study aims to describe the clinical practice and long-term survival benefits of patients newly diagnosed with unresectable stage IIIB/IIIC/IV NSCLC. The study also seeks to explore the condition of biomarker tests utilization, and to assess potential economic impact on patients in the real world. The safety related events will also be summarized in this study.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Chest Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Cohort 1:

  • Participants who have diagnosed with unresectable stage IIIB/IIIC/IV NSCLC
  • Participants who have been diagnosed six months before the start of the study were required to have two complete tumor assessments within at least 6 months intervals after the diagnosis
  • Participants who were newly diagnosed within six months before the start of the study were required to have complete baseline information (see section 6.4.1)
  • Participants who have received standard first-line treatment defined by guideline CSCO (https://www.csco.org.cn/cn/index.aspx) and NCCN (https://www.nccn.org/)

Cohort 2:

  • Participants who are newly diagnosed with unresectable Stage IIIB/IIIC/IV NSCLC after the start of the study
  • Participants who are able to be followed up by the participating site
  • Participants planned to receive first line anti-cancer treatment targeting unresectable stage IIIB/IIIC/IV NSCLC in the study site after study initiation

Exclusion criteria

  • Participants who have received prior systematic treatment for unresectable Stage IIIB/IIIC/IV NSCLC
  • Participants who have participated in any anti-cancer, regimen-specified clinical study of first-line treatment for unresectable Stage IIIB/IIIC/IV NSCLC

Treatment and study plan

Primary outcomes

  1. Median Overall Survival (OS)

    Time frame: Up to 2 years

    OS is defined as the time from the date of the first administration of anti-cancer treatment until the date of death from any cause.

  2. Median weeks on first-line treatment

    Time frame: Up to 2 years

    First-line treatment will be reported by class of treatment. Median, minimum, and maximum values will be used to summarize the number of weeks on the first line of treatment.

Secondary outcomes

  1. Tumor Molecular Characteristics, measured by the presence of defined biomarkers

    Time frame: Up to 2 years

    The defined biomarkers to be identified are EGFR mutations, ALK rearrangement, ROS1 rearrangement, BRAF mutation, neurotrophic tyrosine receptor kinase [NTRK] gene fusion, KRAS mutations, and MET mutations. RET rearrangement, ERBB2 (HER2) mutation, and PD-L1 expression.

  2. Treatment Cost to the Participant, measured by accrued fees; pharmacy fee, treatment fee, examinations fee, insurance coverage, and other medical costs

    Time frame: Up to 2 years

  3. Number of participants with at least one adverse event, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0)

    Time frame: Up to 2 years

  4. Anti-cancer Treatment Duration

    Time frame: Up to 2 years

  5. Number of Cycles of Anti-cancer Treatment

    Time frame: Up to 2 years

  6. Number of Dose Modifications of Anti-Cancer Treatment

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Observational Cohort Study of Patients With Newly Diagnosed Unresectable Stage IIIB, IIIC, or IV Non-Small-Cell Lung Cancer (NSCLC) in China

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 24, 2023
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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