Efficacy of Neoadjuvant Immunotherapy in Patients With Lung Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-79
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

Patients with lung cancer who receive neoadjuvant immunotherapy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Pneumonectomy

    Procedure/Surgery

    Patients will receive pneumonectomy after neoadjuvant treatment

  • lobectomy

    Procedure/Surgery

    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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Surgery2 interventions
Group B: Non-surgery2 interventions

Trial outcomes

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

Complications after the neoadjuvant treatment.

Time frame
Within 6 months after neoadjuvant treatment.

Other outcomes

Sponsors and contacts

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