The Real World Study of Neoadjuvant Immunotherapy in Early Stage NSCLC in China
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGuangdong Association of Clinical Trials
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Stage IIA-IIIA NSCLC
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Immunotherapy
DrugPatients in this group should be histologically confirmed potentially resectable NSCLC with stage II-IIIA. Furthermore patients would receive either single agent immunotherapy or immunotherapy combined with chemotherapy.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Neoadjuvant immunotherapy1 intervention
Trial outcomes
Primary outcomes
1
MPR
To evaluate the major pathological response (MPR) rate of participants
Time frame
From the date of surgery up to 10 weeksSecondary outcomes
1
Objective Response Rate
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame
From the date of surgery up to 10 weeks2
MPR based on diverse PD-L1 expression
Percentage of Participants with Major Pathologic Response Rates For Programmed Death Ligand 1 (PD-L1)-Positive Versus PD-L1-Negative Participants
Time frame
From the date of surgery up to 10 weeks3
Percentage of Participants with Adverse Events
No delayed resection rate and incidence of adverse event (AE)/serious adverse event (SAE)
Time frame
From the date of the first cycle of neoadjuvant treatment until 90 days after end of treatment, assessed up to 100 months4
Progression Free Survival (PFS)
Progression Free Survival
Time frame
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 monthsOther outcomes
1
Pathological Complete Response (pCR)
Evaluation of the pathological complete response: The pathological complete response is defined as the absence of residual tumor in lung and lymph nodes in patients treated with chemo-immunotherapy versus patients treated with chemotherapy alone
Time frame
From the date of surgery up to 10 weeksSponsors and contacts
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Source ClinicalTrials.gov