A Study of Real-world Treatment Patterns and Outcomes in Chinese Advanced NSCLC Patients Who Previously Received at Least 2 Line Treatments (RECAP)

August 1, 2025 updated by: Daiichi Sankyo

Real-world Treatment Patterns and Outcomes in Chinese Advanced NSCLC Patients Who Previously Received at Least 2 Line Treatment: a Multi-center, Non-interventional and Retrospective Real-world Study (RECAP)

This study will retrospectively collect data of patients with advanced non-small cell lung cancer who have received at least 2 line treatment to investigate treatment patterns, relevant outcomes, and biomarkers detection patterns in Chinese patients with Actionable Genomic Alterations (AGA) or non-AGA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1041

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing Cancer Hospital
      • Fuzhou, China
        • The First Affiliated Hospital of Fujian Medical University
      • Guangzhou, China
        • Sun Yat-sen University Cancer Center
      • Jinan, China
        • Affiliated Cancer Hospital of Shandong First Medical University
      • Shenyang, China
        • Liaoning cancer Hospital & Institute
      • Suzhou, China
        • The First Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with advanced NSCLC who have received at least 2L treatment between September 1, 2019, and December 31, 2022.

Description

Inclusion Criteria:

  1. Participants aged ≥18 years when diagnosed with advanced NSCLC.
  2. Histologically or cytologically confirmed stage IV NSCLC.
  3. For non-AGA participants , second- or third-line systemic treatment occurred between September 1, 2019 and December 31, 2022, and participants received corresponding immunotherapy in the first or second line.
  4. For AGA participants , second- or third-line systemic treatment occurred between September 1, 2019 and December 31, 2022. Among them, participants with documented positive result for EGFR, ALK, or ROS1 testing received corresponding targeted therapy in the first or second line.

Exclusion Criteria:

This study excludes participants who met any of the following criteria.

  1. Having records of participation or past participation in clinical trial for lung cancer within the data collection period of the study.
  2. Participants with a concomitant cancer at the time of diagnosis of NSCLC (except for non-metastatic non-melanoma skin cancers, in situ or benign neoplasms). Occurrence of cancer within 5 years after NSCLC diagnosis will be considered as secondary cancer.
  3. Histology of the tumor is small cell lung cancer, neuroendocrine in origin, or a mixed histologic type with small cell and non-small cell lung cancers.
  4. Participants with significantly missing medical record data or patients deemed inappropriate for inclusion by investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AGA Cohort
NSCLC participants with AGA that received second-line or above therapies treatment.
Other: No drug
This is a non-interventional study and no study drug will be provided.
Non-AGA Cohort
NSCLC participants with non-AGA that received second-line or above therapies treatment.
Other: No drug
This is a non-interventional study and no study drug will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of real-world treatment regimens for second- or third-line therapy in patients with advanced NSCLC
Time Frame: 40 months
40 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2024

Primary Completion (Actual)

January 26, 2025

Study Completion (Actual)

July 30, 2025

Study Registration Dates

First Submitted

September 25, 2024

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 3, 2025

Last Update Submitted That Met QC Criteria

August 1, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS1062-0001-NIS-MA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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