Clinical trial NCT04286841: The Real World Study of Neoadjuvant Immunotherapy in Early Stage NSCLC in China
Official title: The Real World Study of Neoadjuvant Immunotherapy in Early Stage NSCLC in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Immunotherapy
Lung Cancer
Keywords: neoadjuvant immunotherapy
NSCLC
Lead sponsor: Guangdong Association of Clinical Trials
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stage IIA-IIIA NSCLC

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: MPR
timeFrame: From the date of surgery up to 10 weeks
Secondary outcomes:
measure: Objective Response Rate
timeFrame: From the date of surgery up to 10 weeks
measure: MPR based on diverse PD-L1 expression
timeFrame: From the date of surgery up to 10 weeks
measure: Percentage of Participants with Adverse Events
timeFrame: From the date of the first cycle of neoadjuvant treatment until 90 days after end of treatment, assessed up to 100 months
measure: Progression Free Survival (PFS)
timeFrame: 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
Other outcomes:
measure: Pathological Complete Response (pCR)
timeFrame: From the date of surgery up to 10 weeks
Locations:
city: Guangzhou
country: China
facility: Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
state: Guangdong
Study officials:
References: