Non-small Cell Lung Cancer (NSCLC)RECAPNCT06617390
A Study of Real-world Treatment Patterns and Outcomes in Chinese Advanced NSCLC Patients Who Previously Received at Least 2 Line Treatments
An observational study of Non-small Cell Lung Cancer (NSCLC), run by Daiichi Sankyo at 6 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- No drug
- How many people
- 1,041 participants
- Where
- 6 sitesChina
- Study dates
- 15 Aug 2024to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with advanced NSCLC who have received at least 2L treatment between September 1, 2019, and December 31, 2022.
Who may be able to join
- Participants aged ≥18 years when diagnosed with advanced NSCLC.
- Histologically or cytologically confirmed stage IV NSCLC.
- 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.
- 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.
Who cannot join
- This study excludes participants who met any of the following criteria.
- Having records of participation or past participation in clinical trial for lung cancer within the data collection period of the study.
- 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.
- 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.
- Participants with significantly missing medical record data or patients deemed inappropriate for inclusion by investigators.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Beijing Cancer Hospital
Beijing
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Sun Yat-sen University Cancer Center
Guangzhou
Affiliated Cancer Hospital of Shandong First Medical University
Jinan
Liaoning Cancer Hospital & Institute
Shenyang
The First Affiliated Hospital of Soochow University
Suzhou
About this study
Official title: 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.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- No drug
- Keywords
- NSCLC, Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No drugOther
This is a non-interventional study and no study drug will be provided.
| Study group | Role | What they receive |
|---|---|---|
| AGA Cohort | NSCLC participants with AGA that received second-line or above therapies treatment. Receives: Other: No drug | |
| Non-AGA Cohort | NSCLC participants with non-AGA that received second-line or above therapies treatment. Receives: Other: No drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of real-world treatment regimens for second- or third-line therapy in patients with advanced NSCLC
Measured: 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start15 Aug 2024
- Primary completion26 Jan 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,041 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617390
- Sponsor's protocol ID
- DS1062-0001-NIS-MA
- Acronym
- RECAP
- Status last verified
- Aug 2025
- First submitted
- 25 Sep 2024
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06617390
- Acronym / sponsor ID
- RECAP / DS1062-0001-NIS-MA
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Keywords
- NSCLC, Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,041 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 26 Jan 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AGA Cohort | – | Other: No drugNSCLC participants with AGA that received second-line or above therapies treatment. |
| Non-AGA Cohort | – | Other: No drugNSCLC participants with non-AGA that received second-line or above therapies treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with advanced NSCLC who have received at least 2L treatment between September 1, 2019, and December 31, 2022.
Key inclusion criteria (4 listed)
- Participants aged ≥18 years when diagnosed with advanced NSCLC.
- Histologically or cytologically confirmed stage IV NSCLC.
- 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.
- 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.
Key exclusion criteria (5 listed)
- This study excludes participants who met any of the following criteria.
- Having records of participation or past participation in clinical trial for lung cancer within the data collection period of the study.
- 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.
- 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.
- Participants with significantly missing medical record data or patients deemed inappropriate for inclusion by investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No drugThis is a non-interventional study and no study drug will be provided. | Other | AGA Cohort, Non-AGA Cohort |
Primary outcome
Percentage of real-world treatment regimens for second- or third-line therapy in patients with advanced NSCLC
Time frame: 40 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer (NSCLC), run by Daiichi Sankyo at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of real-world treatment regimens for second- or third-line therapy in patients with advanced NSCLC (time frame: 40 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.