Lung Cancer (NSCLC)NCT07596524
Analysis of Different Second Line Treatment in Advanced NSCLC Patients Progressing After 1st Line Immune Checkpoint Inhibitor Therapy
An observational study of Lung Cancer (NSCLC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 3 sites in China.
Trial summary
The second-line treatment options in clinical practice for immunotherapy progress are complex. Treatment strategies need to be selected based on different progression patterns. It is difficult to simultaneously explore multiple treatment modalities through previous clinical studies. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- Observation
- How many people
- 300 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jul 2026to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospital-based
Who may be able to join
- Locally advanced or metastatic NSCLC that is not curable and confirmed by histological or cytological examination based on the 8th edition of AJCC staging.
- Previously received advanced first-line treatment based on immune checkpoint inhibitor drugs.
- Has a medical record of disease progression during the first-line treatment.
- Complete clinical and pathological data, such as age, gender, smoking history, primary tumor location, differentiation, metastatic site, and imaging and serological review as required.
Who cannot join
- First-line treatment with immune checkpoint inhibitor drugs was ≤ 2 cycles.
- Excluding patients with incomplete key baseline and treatment information.
- Have other potential factors that may affect the study results or result in the premature discontinuation, as determined by the investigator
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Cancer Hospirtal, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Jianchun Duan, M.D., +8610-87788029, duanjianchun79@163.com
Cancer Hospirtal, Chinese Academy of Medical Sciences, Shenzhen
Shenzhen, Guangdong, 518116
Jianchun Duan, M.D., +8613811259820, duanjianchun79@163.com
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013
Jianchun Duan, M.D., +8613811259820, duanjianchun79@163.com
About this study
Official title: Analysis of Different Treatment Modalities and Clinical Outcomes in Advanced NSCLC Patients Progressing After First-Line Immune Checkpoint Inhibitor Therapy: An Observational Study Based on Real-World Data
The second-line treatment options in clinical practice for immunotherapy progress are complex. Treatment strategies need to be selected based on different progression patterns. It is difficult to simultaneously explore multiple treatment modalities through previous clinical studies. Observational studies through real-world research can efficiently convert clinical practice data into clinical treatment evidence. This study aims to observe the treatment patterns and clinical outcomes of advanced NSCLC patients who received first-line immunotherapy checkpoint inhibitor treatment after progression, in order to provide guidance for the second-line treatment options for patients with first-line immunotherapy progress.
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- Observation
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
The patients' second-line treatment received and the follow-up observations were retrospectively collected.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Patients with advanced NSCLC who have received standard first-line immune checkpoint inhibitor therapy and have experienced disease progression. Retrospective case screening and collection were conducted, and follow-up observations were carried out. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
The overall survival time of the patients enrolled.
Measured: Time from 2nd line treatment initiation to patient death from any cause, assessed up to 60 months
Progression Free Survival
The time of disease progression free survival.
Measured: Time from 2nd line treatment initiation to the first recorded progression event in the medical information system (radiographic report or physician assessment) or death from any cause, whichever occurs first, assessed up to 60 months
Secondary outcomes (3)
Objective Response Rate
Overall response rate
Measured: From 2nd line treatment initiation, assessed up to 24 months
Disease control rate
Disease control rate
Measured: From 2nd line treatment initiation, assessed up to 24 months
Immune-related adverse events
Immune-related adverse events
Measured: From 2nd line treatment initiation and before 3rd line treatment, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JIANCHUN DUAN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Jianchun Duan, M.D., Principal investigator, Cancer Hospirtal Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596524
- Sponsor's protocol ID
- NCC-021875
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Whether IPD will be provided will be determined by the results of subsequent clinical trials. At present, it is impossible to determine.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Different Treatment Modalities and Clinical Outcomes in Advanced NSCLC Patients Progressing After First-Line Immune Checkpoint Inhibitor Therapy: An Observational Study Based on Real-World Data
- ClinicalTrials.gov ID
- NCT07596524
- Acronym / sponsor ID
- NCC-021875
- Conditions
- Lung Cancer (NSCLC)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 19 May 2026 (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.
The second-line treatment options in clinical practice for immunotherapy progress are complex. Treatment strategies need to be selected based on different progression patterns. It is difficult to simultaneously explore multiple treatment modalities through previous clinical studies. Observational studies through real-world research can efficiently convert clinical practice data into clinical treatment evidence. This study aims to observe the treatment patterns and clinical outcomes of advanced NSCLC patients who received first-line immunotherapy checkpoint inhibitor treatment after progression, in order to provide guidance for the second-line treatment options for patients with first-line immunotherapy progress.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Other: ObservationPatients with advanced NSCLC who have received standard first-line immune checkpoint inhibitor therapy and have experienced disease progression. Retrospective case screening and collection were conducted, and follow-up observations were carried out. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital-based
Key inclusion criteria (4 listed)
- Locally advanced or metastatic NSCLC that is not curable and confirmed by histological or cytological examination based on the 8th edition of AJCC staging.
- Previously received advanced first-line treatment based on immune checkpoint inhibitor drugs.
- Has a medical record of disease progression during the first-line treatment.
- Complete clinical and pathological data, such as age, gender, smoking history, primary tumor location, differentiation, metastatic site, and imaging and serological review as required.
Key exclusion criteria (3 listed)
- First-line treatment with immune checkpoint inhibitor drugs was ≤ 2 cycles.
- Excluding patients with incomplete key baseline and treatment information.
- Have other potential factors that may affect the study results or result in the premature discontinuation, as determined by the investigator
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 |
|---|---|---|
| ObservationThe patients' second-line treatment received and the follow-up observations were retrospectively collected. | Other | Observation |
Primary outcome
Overall Survival
Time frame: Time from 2nd line treatment initiation to patient death from any cause, assessed up to 60 months
The overall survival time of the patients enrolled.
Progression Free Survival
Time frame: Time from 2nd line treatment initiation to the first recorded progression event in the medical information system (radiographic report or physician assessment) or death from any cause, whichever occurs first, assessed up to 60 months
The time of disease progression free survival.
3 secondary outcomes
Objective Response Rate
Time frame: From 2nd line treatment initiation, assessed up to 24 months
Disease control rate
Time frame: From 2nd line treatment initiation, assessed up to 24 months
Immune-related adverse events
Time frame: From 2nd line treatment initiation and before 3rd line treatment, assessed up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided. Whether IPD will be provided will be determined by the results of subsequent clinical trials. At present, it is impossible to determine.
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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.
Jianchun Duan, M.D. principal investigator
Cancer Hospirtal Chinese Academy of Medical Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (NSCLC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 3 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 3 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: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianchun Duan, M.D. (+8610-87788029, duanjianchun79@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Time from 2nd line treatment initiation to patient death from any cause, assessed up to 60 months). 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 19 May 2026.