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NCT Number: NCT07256002

Survival Analysis and Prognostic Biomarker Exploration of Postoperative Adjuvant Therapy Patterns in Patients With Non-small Cell Lung Cancer After Neoadjuvant Immunotherapy

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?

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100020, China

About this study

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:

  • Is there a difference in survival between patients who achieve pCR after neoadjuvant immunotherapy and those who do not receive adjuvant therapy?
  • 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?
  • 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.)?
  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who visited the hospital from January 2020 to December 2023;
  • Received neoadjuvant immunotherapy before surgery;
  • Histologically diagnosed with stage II-III NSCLC;
  • Had measurable lesions as assessed by the investigator using the RECIST 1.1 version;
  • Underwent radical surgical treatment;
  • ECOG score of 0 or 1;
  • Available tumor tissue samples;
  • Good blood and organ functions.

Exclusion criteria

  • 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);
  • Has a history of previous malignant tumors.

Treatment and study plan

PD-1 Inhibitors

Drug

Adjuvant PD-1 inhibitor maintenance therapy

Chemotherapy

Drug

Postoperative chemotherapy as an adjuvant treatment

PD-1 inhibitors combined with chemotherapy

Drug

Postoperative PD-1 inhibitor combined with chemotherapy as adjuvant therapy

Primary outcomes

  1. Overall Survival (OS)

    Time frame: 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 outcomes

  1. Event-free survival(EFS)

    Time frame: 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.

  2. Pathological Complete Response(pCR)

    Time frame: up to 1 month after surgery

    After evaluating the removed tumor tissue and the regional lymph nodes, no residual tumor cells were found.

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

Survival Analysis and Prognostic Biomarker Exploration of Postoperative Adjuvant Therapy Patterns in Patients With Non-small Cell Lung Cancer After Neoadjuvant Immunotherapy:A Real World Multicenter Retrospective Study

Important dates

Study start
2020
Primary completion
2023
Study completion
2027
First posted
Dec 1, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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