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

  • STATUS
    Recruiting
  • End date
    Dec 29, 2029
  • participants needed
    100
  • sponsor
    Guangdong Association of Clinical Trials
Send
Updated on 19 February 2024
See if I qualify
cancer
measurable disease
lung cancer
pneumonectomy
non-small cell lung cancer
EGFR
small cell lung cancer
alk gene translocation

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.

Details
Condition Pulmonary Disease, Lung Neoplasm, Immunotherapy
Age 18years - 100years
Treatment Immunotherapy
Clinical Study IdentifierNCT04286841
SponsorGuangdong Association of Clinical Trials
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Written informed consent provided
Males or females aged 18 years
Able to comply with the required protocol and follow-up procedures
Pathologically diagnosed of potentially resectable non-small cell lung cancer with stage II-IIIA (TNM 8th edition)
Measurable disease must be characterized according to RECIST 1.1 criteria
ECOG performance status 0-1
Regardless of PD-L1 expression
EGFR mutation (-) and ALK translocation (-)
Pulmonary function could be well tolerated by lobectomy or pneumonectomy

Exclusion Criteria

EGFR mutation (+) or ALK translocation (+)
Active Central nervous system (CNS) metastases
Patients with active, known or suspected autoimmune disease
Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement or unexpected conditions of recurrence in the absence of an external trigger are allowed to be included
Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment
Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
Patients with a history of interstitial lung disease cannot be included if they have symptomatic ILD (Grade 3-4) and/or poor lung function. Patients with other active malignancy requiring concurrent intervention and/ or concurrent treatment with other investigational drugs or anti-cancer therapy
Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/ dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period
Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information
Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways Patients with positive test for hepatitis B virus surface antigen (HBVsAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating active hepatitis
Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) Patients with history of allergy to study drug components excipients
Women who are pregnant or in the period of breastfeeding
Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study
In case of doubt please contact trial team
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

cancer
measurable disease
lung cancer
pneumonectomy
non-small cell lung cancer
EGFR
small cell lung cancer
alk gene translocation

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.