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Enrolling by Invitation

NCT Number: NCT07373899

Comparison of the Effect of Surgical Resection Based on Lesion Extent Before and After Neoadjuvant Therapy in Patients With Stage II-IIIB Non-Small Cell Lung Cancer: A Single-Center, Real-World, Open-Label Study

This study intends to conduct a prospective, non-interventional study to compare the survival benefits of different surgical resection patterns for patients with non-small cell lung cancer who have achieved partial response (PR) after immunotherapy induction. The study plans to enroll patients suitable for surgery as assessed by radiomics evaluation and multidisciplinary team (MDT) discussion, and will assign them to the modified surgery group and the conventional surgery group based on patient preference. The resection scope in the modified surgery group is more limited compared to conventional surgery, aiming to maximize preservation of pulmonary function while ensuring oncological safety. This study will systematically evaluate the impact of different resection scopes on patient prognosis after neoadjuvant immunotherapy, providing clinical evidence for exploring individualized surgical strategies for non-small cell lung cancer in the era of immunotherapy.

Enrolling by Invitation

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Chaoyang, 250101, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically confirmed non-small cell lung cancer (NSCLC)
  • Achieved resectability after neoadjuvant immunotherapy with or without chemotherapy
  • Initially required pneumonectomy or combined lobectomy based on tumor size and extent, but became suitable for minimally invasive resection after neoadjuvant treatment
  • Age ≥ 18 years
  • ECOG performance status score of 0-1
  • Complete imaging, pathological, and follow-up data available

Exclusion criteria

  • Disease progression (PD) after neoadjuvant therapy
  • Still required pneumonectomy or combined lobectomy after neoadjuvant therapy, with no reduction in the planned surgical extent
  • Intraoperative findings indicating that R0 resection was not feasible
  • Severe cardiopulmonary dysfunction or other complications that made the patient unable to tolerate surgery

Treatment and study plan

Primary outcomes

  1. Disease-free survival

    Time frame: Evaluate over a period of up to five years

    It refers to the period from the beginning of the study until the recurrence of the disease or any cause of death.

Secondary 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 5 years.

    OS is defined as the time from surgery time until death from any cause.

  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.

  3. Incidence of perioperative complications

    Time frame: up to 1 month after surgery

    The perioperative period refers to a certain period before, during and after the surgery. Postoperative pulmonary complications refer to various respiratory system complications that occur in patients after the surgery.

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jan 28, 2026
Registry last updated
Jul 24, 2026

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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