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Monoclonal Antibodies

The Real World Study of Neoadjuvant Immunotherapy in Early Stage NSCLC in China

N/A
Recruiting
Research Sponsored by Guangdong Association of Clinical Trials
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of the first cycle of neoadjuvant treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Awards & highlights
No Placebo-Only Group

Summary

Several published clinical trials have shown the superiority of immunotherapy in neoadjuvant setting. Here we conducted this real world study to see whether neoadjuvant immunotherapy would bring MPR and survival benefits in NSCLC, for example, single agent immunotherapy or immunotherapy combination with chemotherapy. Furthermore biomarker analysis would be also performed to achieve personalized neoadjuvant immunotherapy.

Eligible Conditions
  • Immunotherapy
  • Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of the first cycle of neoadjuvant treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of the first cycle of neoadjuvant treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MPR
Secondary study objectives
MPR based on diverse PD-L1 expression
Objective Response Rate
Percentage of Participants with Adverse Events
+1 more
Other study objectives
Pathological Complete Response (pCR)

Side effects data

From 2008 Phase 4 trial • 275 Patients • NCT00267202
20%
Injection site reaction
14%
Upper respiratory tract infection
14%
Injection site erythema
14%
Injection site pruritus
12%
Nasopharyngitis
10%
Injection site swelling
6%
Injection site urticaria
6%
Injection site induration
5%
Headache
5%
Pruritus
5%
Sinusitis
4%
Cough
2%
Viral upper respiratory tract infection
1%
Abortion induced
1%
Asthma
1%
Rectal cancer
1%
Cellulitis staphylococcal
1%
Sexual abuse
100%
80%
60%
40%
20%
0%
Study treatment Arm
Omalizumab
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Neoadjuvant immunotherapyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Immunotherapy
2016
Completed Phase 4
~1530

Find a Location

Who is running the clinical trial?

Guangdong Association of Clinical TrialsLead Sponsor
41 Previous Clinical Trials
14,847 Total Patients Enrolled
~15 spots leftby Dec 2025
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