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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05872763
• Collaborator: (none)
• Enrollment: 1,200
• Anticipated Duration (Months): 24

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1200 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: An Observational Cohort Study of Patients With Newly Diagnosed Unresectable Stage IIIB, IIIC, or IV Non-Small-Cell Lung Cancer (NSCLC) in China
• Anticipated Study Start Date: Jun 30, 2023
• Anticipated Primary Completion Date: Jun 30, 2025
• Anticipated Study Completion Date: Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Retrospective cohort (Cohort 1) All cases of unresectable stage IIIB/IIIC/IV NSCLC newly diagnosed between January 2020 and the date of the study initiation will be collected. All these participants will be followed up until death or lost-to-follow-up or until 12 months after the last participant is enrolled in cohort 2 in the study.
Prospective cohort (Cohort 2) The prospective enrollment of new cases of unresectable stage IIIB/IIIC/IV NSCLC will end up to 1 year after the first patient is enrolled (FPI) in Cohort 2.

Outcome Measures

Primary Outcome Measures

1. Median Overall Survival (OS) [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 [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 Outcome Measures

1. Tumor Molecular Characteristics, measured by the presence of defined biomarkers [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 [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) [Up to 2 years]

4. Anti-cancer Treatment Duration [Up to 2 years]

5. Number of Cycles of Anti-cancer Treatment [Up to 2 years]

6. Number of Dose Modifications of Anti-Cancer Treatment [Up to 2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT05872763
• Other Study ID Numbers: ML44633
• First Posted: May 24, 2023
• Last Update Posted: May 24, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hoffmann-La Roche: Non-Small Cell Lung Cancer
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of May 24, 2023