Lung Cancer (NSCLC)
Conditions
Brief summary
The aim of this observational study is to investigate the survival differences among patients with non-small cell lung cancer who received different adjuvant treatments after neoadjuvant immunotherapy, and to identify the main clinical characteristics of these survival differences. The main question it aims to answer is: 1. Is there a difference in survival between patients who achieve pCR after neoadjuvant immunotherapy and those who do not receive adjuvant therapy? 2. What are the recurrence patterns and high-risk factors for recurrence in patients with pCR after neoadjuvant immunotherapy, and how can early intervention be carried out? 3. Is there a difference in survival among patients with non-MPR after neoadjuvant immunotherapy when they receive different adjuvant treatment modalities (single immunotherapy, chemio-immunotherapy, chemotherapy, etc.)? 4. Should patients with non-MPR after neoadjuvant immunotherapy continue immunotherapy, and what are the predictive markers for receiving adjuvant therapy?
Detailed description
The aim of this observational study is to investigate the survival differences among patients with non-small cell lung cancer who received different adjuvant treatments after neoadjuvant immunotherapy, and to identify the main clinical characteristics of these survival differences. The main question it aims to answer is: 1. Is there a difference in survival between patients who achieve pCR after neoadjuvant immunotherapy and those who do not receive adjuvant therapy? 2. What are the recurrence patterns and high-risk factors for recurrence in patients with pCR after neoadjuvant immunotherapy, and how can early intervention be carried out? 3. Is there a difference in survival among patients with non-MPR after neoadjuvant immunotherapy when they receive different adjuvant treatment modalities (single immunotherapy, chemio-immunotherapy, chemotherapy, etc.)? 4. Should patients with non-MPR after neoadjuvant immunotherapy continue immunotherapy, and what are the predictive markers for receiving adjuvant therapy? Participants will undergo neoadjuvant immunotherapy and surgical procedures, and through rigorous analysis of real-world data, this study endeavors to provide nuanced insights into these fundamental queries, fostering advancements in clinical decision-making and patient management strategies.
Interventions
DRUGPD-1 Inhibitors
Adjuvant PD-1 inhibitor maintenance therapy
DRUGChemotherapy
Postoperative chemotherapy as an adjuvant treatment
DRUGPD-1 inhibitors combined with chemotherapy
Postoperative PD-1 inhibitor combined with chemotherapy as adjuvant therapy
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Inclusion criteria
1. Patients who visited the hospital from January 2020 to December 2023; 2. Received neoadjuvant immunotherapy before surgery; 3. Histologically diagnosed with stage II-III NSCLC; 4. Had measurable lesions as assessed by the investigator using the RECIST 1.1 version; 5. Underwent radical surgical treatment; 6. ECOG score of 0 or 1; 7. Available tumor tissue samples; 8. Good blood and organ functions.
Exclusion criteria
1. Has received other anti-tumor treatments before, including radiotherapy, chemotherapy and traditional Chinese medicine-based cancer treatment (except for malignant tumor treatments that have been cured and have no recurrence or metastasis for more than 5 years); 2. Has a history of previous malignant tumors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 7 years and 11 months. | OS is defined as the time from surgery time until death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival(EFS) | up to 7 years and 11 months. | Event-free survival was defined as the time from neoadjuvant treatment to metastasis or death by any cause in the absence of metastasis. |
| Pathological Complete Response(pCR) | up to 1 month after surgery | After evaluating the removed tumor tissue and the regional lymph nodes, no residual tumor cells were found. |
Countries
China
Outcome results
None listed