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NCT Number: NCT07166003

Efficacy of Neoadjuvant Immunotherapy in Patients With Lung Cancer

The goal of this observational study is to learn about the long-term effects of neoadjuvant immunotherapy in patients with lung cancer. The main questions it aims to answer are:

* Does pneumonectomy bring more benefits for pateints than lobectomy? * Does surgery bring more benefits for patients than non-surgery modalities (such as radiotherapy) after neoadjuvnat immunotherapy? Participants will receive neoadjuvant treatment and the study will analyze the data.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Location status: Recruiting

Location contact

Shugeng Gao, MD

CONTACT

[email protected]

8610-87788177

About this study

This observational study aims to comprehensively evaluate the effectiveness and long-term clinical outcomes of neoadjuvant treatment in patients with lung cancer. Central to this investigation are two key questions: ·Does pneumonectomy bring more benefits for pateints than lobectomy?

  • Does surgery bring more benefits for patients than non-surgery modalities (such as radiotherapy) after neoadjuvnat immunotherapy? Participants will receive neoadjuvant treatment, and through rigorous analysis of 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

  • Aged between 18 and 79 years;
  • Received at least two cycles of neoadjuvant immunotherapy;
  • ECOG performance status score of 0;
  • Complete clinical information including imaging data available.

Exclusion criteria

  • Diagnosed with or suspected active autoimmune diseases;
  • Presence of EGFR/ALK sensitive mutations;
  • Pregnant or breastfeeding women;
  • Previous anti-tumor therapies including chemotherapy or radiotherapy;
  • History of organ transplantation or hematopoietic stem cell transplantation;
  • Interstitial pneumonia, pulmonary fibrosis, or severe emphysema;
  • Uncontrolled diabetes mellitus;
  • Uncontrolled hypertension.

Treatment and study plan

Pneumonectomy

Procedure

Patients will receive pneumonectomy after neoadjuvant treatment

Lobectomy

Procedure

Patients will receive lobectomy after neoadjuvant immunotherapy.

Radiotherapy

Radiation

Patients will receive radiotherapy after neoadjuvant immunotherapy.

Anti-Tumor Drugs

Drug

Patients will receive anti-tumor drugs.

Primary outcomes

  1. Event-free survival

    Time frame: Event-free survival was defined as the time from neoadjuvant treatment to metastasis or death by any cause in the absence of metastasis, up to approximately 10 years.

Secondary outcomes

  1. Overall survival

    Time frame: From date of neoadjuvant treatment until date of death due to any cause, up to approximately 10 years.

  2. Perioperative Complication rate

    Time frame: Within 6 months after neoadjuvant treatment.

    Complications after the neoadjuvant treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Shugeng Gao, MD

CONTACT

[email protected]

8610-87788177

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

Effects of Neoadjuvant Immunotherapy on Patients With Lung Cancer: a Prospective, Observational Study

Acronym: NeoIP-Lung

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Sep 10, 2025
Registry last updated
Sep 10, 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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