NSCLC Stage IVNCT04492969
Prospective Observation of Failure Patterns in NSCLC Treated With ICIs
An observational study of NSCLC Stage IV and NSCLC, Recurrent, run by Fudan University at 1 site in China.
Trial summary
By prospectively observing the time to the best therapeutic effect of non-small cell lung cancer after ICI treatment, the characteristics of lesion distribution when the best therapeutic effect is reached, and the phenotype of disease progression after ICI treatment response, the investigators intended to explore the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC Stage IV, NSCLC, Recurrent
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 31 Aug 2025
- How long will I take part?
- 3 Years
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: stage IV NSCLC developing acquired resistance under ICI treatment.
Who may be able to join
- Age between 18 and 75 years.
- ECOG PS 0-1.
- Pathologically confirmed stage IV NSCLC.
- Negative for driver genes including EGFR, ALK, and ROS-1.
- Patients achieved PR or CR after ICI treatment, as defined by RECIST 1.1.
- Patients with complete radiological information of baseline lesions.
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- Life expectancy of more than 3 months.
- Ability to understand and willingness to provide the informed consent.
- Patients with oligo-progression disease (1-3 progression lesions in 1-2 organs) when developing acquired resistance to ICI.
- Radiotherapy to at least one of the OPD lesions is indicated in the opinion of the investigator. At least one of the irradiated lesion(s) should be evaluable according to RECIST 1.1.
- ECOG PS 0-2.
- Life expectancy of more than 3 months.
- Complete radiological information of all lesions during the follow-up.
- Patients with a prior history of surgery are eligible if they have recovered adequately from the toxicity and/or complications of surgery.
- Adequate bone marrow function within 1 week prior to the enrollment: hemoglobin ≥80g/L, white blood cell (WBC) count ≥ 4.0 * 10 ^ 9/L or neutrophil count ≥ 1.5 * 10 ^ 9/L, and platelet count ≥ 100 * 10 ^ 9/L;
- Ability to understand and willingness to provide the informed consent.
Who cannot join
- Severe autoimmune disease or other contradictions to ICI treatment.
- Mixed small cell with non-small cell lung cancer histology.
- Driver gene positive, including EGFR, ALK, and ROS-1.
- Pregnant or lactating women.
- History of any other malignancy.
- Active infection, congestive heart failure, myocardial infarction within the 6 months prior to enrollment, unstable angina pectoris or cardiac arrhythmia.
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- Patients receiving immunosuppressive agents,or other investigational treatment. Long-term corticosteroid users are also excluded.
- Mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.
- Secondary malignancy.
- Histology transformation to non-NSCLC.
- Ineligible for radiotherapy in the opinion of the investigator. Or none of the OPD are evaluable by RECIST 1.1.
- ECOG PS 3 or worse.
- Short life expectancy (less than 3 months).
- Unable to provide complete radiological information of lesions.
- Inadequate bone marrow function.
- Cannot understand or unwilling to provide the informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200031
Zhengfei Zhu, MD, +86-18017312901, fuscczzf@163.com
Xiao Chu, 15821383376, crazychu0044@163.com
About this study
Official title: Prospective Observational Study of Failure Patterns in Non-small Cell Lung Cancer Patients Treated With Immune Checkpoint Inhibitors
By prospectively observing the time to the best therapeutic effect of non-small cell lung cancer after ICI treatment, the characteristics of lesion distribution when the best therapeutic effect is reached, and the phenotype of disease progression after ICI treatment response, the investigators intended to explore the failure pattern of NSCLC after the once effective ICI treatment. The investigators also aim to evaluate the feasibility and clinical value of radiotherapy for the treatment of oligo-progressive lesions after ICI.
- Conditions
- NSCLC Stage IV, NSCLC, Recurrent
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Oligo-progression disease rate in NSCLC patients developing acquired resistance to ICI treatment.
Acquired resistance (AR) was defined as disease progression after partial or complete response (PR or CR) to ICI treatment. (by RECIST standard v1.1)
When observing disease progression in ICI treatment, the number and distribution of progression lesions were recorded.
Oligo-progression disease (OPD) was defined as 1-3 progression lesions in 1-2 organs. The OPD rate in all AR cases will be calculated.
Measured: at least 2 months after ICI treatment.
Secondary outcomes (4)
Overall objective response rate to radiotherapy.
When radiotherapy to at least one of the OPD lesions is indicated in the opinion of the investigator. Overall objective response rate (ORR) to radiotherapy will be recorded. ORR was defined as the proportion of participants with partial response (PR) or complete response (CR) to treatment as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Measured: at least 4 weeks after radiotherapy.
Objective response rate in non-irradiated lesion
Objective response rate (ORR) in Non-irradiated Lesion was defined as the proportion of patients with at least 30% reduction from baseline in the longest diameter of any of non-irradiated target lesions defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at any time-point from the date of treatment initiation to the date of last follow-up.
Measured: at least 4 weeks after radiotherapy.
Percentage of Participants With Adverse Events
Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0.
Measured: Two years
Overall Survival since AR development.
OS was defined as the time from the date of enrollment until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IVStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Prospective
- Enrolment
- 320 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengfei Zhu, Fudan University
- Investigators
- Zhengfei Zhu, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492969
- Sponsor's protocol ID
- 2019-CSCOBMS
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Failure Patterns in Non-small Cell Lung Cancer Patients Treated With Immune Checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT04492969
- Acronym / sponsor ID
- 2019-CSCOBMS
- Conditions
- NSCLC Stage IV, NSCLC, Recurrent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 30 Jul 2020 (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.
By prospectively observing the time to the best therapeutic effect of non-small cell lung cancer after ICI treatment, the characteristics of lesion distribution when the best therapeutic effect is reached, and the phenotype of disease progression after ICI treatment response, the investigators intended to explore the failure pattern of NSCLC after the once effective ICI treatment. The investigators also aim to evaluate the feasibility and clinical value of radiotherapy for the treatment of oligo-progressive lesions after ICI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- stage IV NSCLC developing acquired resistance under ICI treatment.
Key inclusion criteria (16 listed)
- Age between 18 and 75 years.
- ECOG PS 0-1.
- Pathologically confirmed stage IV NSCLC.
- Negative for driver genes including EGFR, ALK, and ROS-1.
- Patients achieved PR or CR after ICI treatment, as defined by RECIST 1.1.
Key exclusion criteria (16 listed)
- Severe autoimmune disease or other contradictions to ICI treatment.
- Mixed small cell with non-small cell lung cancer histology.
- Driver gene positive, including EGFR, ALK, and ROS-1.
- Pregnant or lactating women.
- History of any other malignancy.
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
Oligo-progression disease rate in NSCLC patients developing acquired resistance to ICI treatment.
Time frame: at least 2 months after ICI treatment.
Acquired resistance (AR) was defined as disease progression after partial or complete response (PR or CR) to ICI treatment. (by RECIST standard v1.1) When observing disease progression in ICI treatment, the number and distribution of progression lesions were recorded. Oligo-progression disease (OPD) was defined as 1-3 progression lesions in 1-2 organs. The OPD rate in all AR cases will be calculated.
4 secondary outcomes
Overall objective response rate to radiotherapy.
Time frame: at least 4 weeks after radiotherapy.
Objective response rate in non-irradiated lesion
Time frame: at least 4 weeks after radiotherapy.
Percentage of Participants With Adverse Events
Time frame: Two years
Overall Survival since AR development.
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
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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.
Zhengfei Zhu, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC Stage IV and NSCLC, Recurrent, run by Fudan University at 1 site 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 16 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhengfei Zhu, MD (+86-18017312901, fuscczzf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oligo-progression disease rate in NSCLC patients developing acquired resistance to ICI treatment. (time frame: at least 2 months after ICI treatment.). 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 31 Jul 2020; AzTrials last refreshed its copy on 6 Nov 2026.