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

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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	18-100 years
Treatment	Immunotherapy
Clinical Study Identifier	NCT04286841
Sponsor	Guangdong Association of Clinical Trials
Last Modified on	19 February 2024

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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

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