Non-small Cell Lung Cancer Stage INCT07250360
Adjuvant Chemotherapy for High-Risk Pathologic Stage I Non-Squamous NSCLC
An observational study of Non-small Cell Lung Cancer Stage I, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
Brief Summary The goal of this clinical trial is to evaluate the effect of postoperative adjuvant chemotherapy (ACT) in patients with stage I non-squamous non-small cell lung cancer (NSCLC) after curative resection. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non-small Cell Lung Cancer Stage I
- What is being tested?
- Adjuvant chemotheapy
- How many people
- 2,072 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jun 2025
- How long will I take part?
- 60 Months
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with non-squamous NSCLC from four participating hospitals
Who may be able to join
- Patients must have histologically confirmed non-squamous NSCLC
- Patients must be ≥18 years of age at the time of diagnosis
- Pathological stage I disease (T1-2N0M0) according to the AJCC 8th edition (specify if applicable)
- Patients must have undergone complete surgical resection (R0) with systematic lymph node dissection
- Surgery performed between January 1, 2015 and December 31, 2019
Who cannot join
- Prior history of malignant tumors or presence of synchronous other primary malignancy
- Multiple primary lung cancers diagnosed at baseline
- Receipt of any neoadjuvant chemotherapy, radiotherapy, or targeted therapy
- Perioperative death occurring within 30 days after surgery
- Incomplete or missing clinical or pathological information
- Loss to follow-up before the first scheduled surveillance assessment
About this study
Official title: Adjuvant Chemotherapy Confers Survival Benefit Only in High-Risk Pathologic Stage I Non-Squamous NSCLC: A Multicenter Prospective Cohort Study and Machine-Learning-Based Decision Tool
Brief Summary The goal of this clinical trial is to evaluate the effect of postoperative adjuvant chemotherapy (ACT) in patients with stage I non-squamous non-small cell lung cancer (NSCLC) after curative resection.
The main questions it aims to answer are:
Read more
Does ACT improve recurrence-free survival (RFS) compared with observation alone?
Does ACT provide disease-free survival (DFS) benefit in this patient population?
Researchers will compare the adjuvant chemotherapy group with the observation group to see if chemotherapy reduces the risk of recurrence and improves survival outcomes.
Participants will:
Receive standard platinum-based adjuvant chemotherapy after surgery or undergo regular postoperative surveillance according to institutional guidelines.
Be followed at scheduled intervals with clinical assessments and imaging to monitor for recurrence and survival outcomes.
- Conditions
- Non-small Cell Lung Cancer Stage I
- Being tested
- Adjuvant chemotheapy
- 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.
Adjuvant chemotheapyDrug
apply adjuvant chemotheapy
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant chemotherapy | Not described Receives: Drug: Adjuvant chemotheapy | |
| Postoperative Observation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year Disease-Free Survival (DFS), defined as time from surgery to recurrence or death, estimated by Kaplan-Meier method.
DFS is defined as the time from surgery to the first documented recurrence or death from any cause, whichever occurs first. Patients without an event will be censored at the last follow-up. Data will be summarized using Kaplan-Meier survival analysis, with median DFS and 95% confidence intervals.
Measured: Up to 5 years after surgery
Secondary outcomes (1)
5-year Recurrence-Free Survival (RFS), defined as time from surgery to the first recurrence or death from any cause, estimated by Kaplan-Meier method
RFS is defined as the time from surgery to the date of first documented tumor recurrence (local, regional, or distant) or death from any cause, whichever occurs first. Patients who are alive and recurrence-free will be censored at the date of last follow-up. Data will be analyzed using Kaplan-Meier survival estimates, with median RFS and 95% confidence intervals reported.
Measured: Up to 5 years after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Jan 2015
- Primary completion31 Dec 2019
- Study completion1 Jun 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 Stage IStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,072 participants (actual)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250360
- Sponsor's protocol ID
- No. 2024-SR-1028
- Other IDs
- No. 2024-SR-1028
- Status last verified
- Feb 2024
- First submitted
- 28 Sep 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Chemotherapy Confers Survival Benefit Only in High-Risk Pathologic Stage I Non-Squamous NSCLC: A Multicenter Prospective Cohort Study and Machine-Learning-Based Decision Tool
- ClinicalTrials.gov ID
- NCT07250360
- Acronym / sponsor ID
- No. 2024-SR-1028
- Conditions
- Non-small Cell Lung Cancer Stage I
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,072 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 26 Nov 2025 (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.
Brief Summary The goal of this clinical trial is to evaluate the effect of postoperative adjuvant chemotherapy (ACT) in patients with stage I non-squamous non-small cell lung cancer (NSCLC) after curative resection.
The main questions it aims to answer are:
Does ACT improve recurrence-free survival (RFS) compared with observation alone?
Does ACT provide disease-free survival (DFS) benefit in this patient population?
Researchers will compare the adjuvant chemotherapy group with the observation group to see if chemotherapy reduces the risk of recurrence and improves survival outcomes.
Participants will:
Receive standard platinum-based adjuvant chemotherapy after surgery or undergo regular postoperative surveillance according to institutional guidelines.
Be followed at scheduled intervals with clinical assessments and imaging to monitor for recurrence and survival outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant chemotherapy | – | Drug: Adjuvant chemotheapy |
| Postoperative Observation | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with non-squamous NSCLC from four participating hospitals
Key inclusion criteria (5 listed)
- Patients must have histologically confirmed non-squamous NSCLC
- Patients must be ≥18 years of age at the time of diagnosis
- Pathological stage I disease (T1-2N0M0) according to the AJCC 8th edition (specify if applicable)
- Patients must have undergone complete surgical resection (R0) with systematic lymph node dissection
- Surgery performed between January 1, 2015 and December 31, 2019
Key exclusion criteria (6 listed)
- Prior history of malignant tumors or presence of synchronous other primary malignancy
- Multiple primary lung cancers diagnosed at baseline
- Receipt of any neoadjuvant chemotherapy, radiotherapy, or targeted therapy
- Perioperative death occurring within 30 days after surgery
- Incomplete or missing clinical or pathological information
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 |
|---|---|---|
| Adjuvant chemotheapyapply adjuvant chemotheapy | Drug | Adjuvant chemotherapy |
Primary outcome
5-year Disease-Free Survival (DFS), defined as time from surgery to recurrence or death, estimated by Kaplan-Meier method.
Time frame: Up to 5 years after surgery
DFS is defined as the time from surgery to the first documented recurrence or death from any cause, whichever occurs first. Patients without an event will be censored at the last follow-up. Data will be summarized using Kaplan-Meier survival analysis, with median DFS and 95% confidence intervals.
1 secondary outcome
5-year Recurrence-Free Survival (RFS), defined as time from surgery to the first recurrence or death from any cause, estimated by Kaplan-Meier method
Time frame: Up to 5 years after surgery.
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 26 Nov 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer Stage I, run by The First Affiliated Hospital with Nanjing Medical University.
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 5 inclusion and 6 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 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
5-year Disease-Free Survival (DFS), defined as time from surgery to recurrence or death, estimated by Kaplan-Meier method. (time frame: Up to 5 years after surgery). 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 26 Nov 2025.