NCT07250360Completed
Adjuvant Chemotherapy for High-Risk Pathologic Stage I Non-Squamous NSCLC
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
Source: ClinicalTrials.gov · Last updated 26 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 2072 (actual)
- First submitted
- 28 Sept 2025
- Start date
- 1 Jan 2015
- Primary completion date
- 31 Dec 2019
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Lung cancer
- NCT number
- NCT07250360
What you commit to
- Study type: Observational
- Participants enrolled: 2072
- From 1 Jan 2015 to the primary completion date, 31 Dec 2019
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of any neoadjuvant chemotherapy, radiotherapy, or targeted therapy
- Perioperative death occurring within 30 days after surgery
Other illness
- Prior history of malignant tumors or presence of synchronous other primary malignancy
- Multiple primary lung cancers diagnosed at baseline
Other
- Incomplete or missing clinical or pathological information
- Loss to follow-up before the first scheduled surveillance assessment
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.