Carcinoma, Non-Small-Cell LungNCT05872763
A Study of Participants in China With Non-Small-Cell Lung Cancer That is Unable to be Treated With Surgery
An observational study of Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 12 sites in China.
Trial 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)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- Type of treatment
- Injection or infusion
- How many people
- 901 participants
- Where
- 12 sitesChina
- Study dates
- 11 Aug 2023to 18 Mar 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will be conducted at multiple sites that will be selected from a pool of hospitals in China from 7 geographic regions (Northwest, Northeast, North, Southwest, South, Central, East) across China. And a target number of 7-10 sites across these regions were planned to be involved to ensure a relatively even number of patients to be enrolled from each region.
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, 100021
Beijing Chest Hospital
Beijing, 101149
Sichuan Provincial Cancer Hospital
Chengdu, 610041
Harbin Medical University Cancer Hospital
Harbin, 150081
Shandong Cancer Hospital
Jinan, 250117
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing, 210029
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, 530021
The Fourth Hospital of Hebei Medical University
Shijiazhuang, 050000
Shanxi Province Cancer Hospital
Taiyuan, 030013
Hubei Cancer Hospital
Wuhan, 430079
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, 710061
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052
About this study
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
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.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Overall Survival (OS)
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.
Measured: Up to 2 years
Median weeks on first-line treatment
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.
Measured: Up to 2 years
Secondary outcomes (6)
Tumor Molecular Characteristics, measured by the presence of defined biomarkers
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.
Measured: Up to 2 years
Treatment Cost to the Participant, measured by accrued fees; pharmacy fee, treatment fee, examinations fee, insurance coverage, and other medical costs
Measured: Up to 2 years
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)
Measured: Up to 2 years
Anti-cancer Treatment Duration
Measured: Up to 2 years
Number of Cycles of Anti-cancer Treatment
Measured: Up to 2 years
Number of Dose Modifications of Anti-Cancer Treatment
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start11 Aug 2023
- Primary completion18 Mar 2026
- Study completion18 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Other
- Enrolment
- 901 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872763
- Sponsor's protocol ID
- ML44633
- Status last verified
- Aug 2026
- First submitted
- 16 May 2023
- Last updated
- 13 Aug 2026
- 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05872763
- Acronym / sponsor ID
- ML44633
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 901 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2023 (actual)
- Primary completion
- 18 Mar 2026 (actual)
- Study completion
- 18 Mar 2026 (actual)
- First posted
- 24 May 2023 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will be conducted at multiple sites that will be selected from a pool of hospitals in China from 7 geographic regions (Northwest, Northeast, North, Southwest, South, Central, East) across China. And a target number of 7-10 sites across these regions were planned to be involved to ensure a relatively even number of patients to be enrolled from each region.
Key inclusion criteria (9 listed)
- 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/)
- Participants who are newly diagnosed with unresectable Stage IIIB/IIIC/IV NSCLC after the start of the study
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
6 secondary outcomes
Tumor Molecular Characteristics, measured by the presence of defined biomarkers
Time frame: Up to 2 years
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
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
Anti-cancer Treatment Duration
Time frame: Up to 2 years
Number of Cycles of Anti-cancer Treatment
Time frame: Up to 2 years
Number of Dose Modifications of Anti-Cancer Treatment
Time frame: Up to 2 years
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 13 Aug 2026.
- 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.
Clinical Trials study director
Hoffmann-La Roche
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 12 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 9 inclusion and 2 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Median Overall Survival (OS) (time frame: Up to 2 years). The study lists 2 primary outcomes in all. 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 13 Aug 2026.