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Trial Title:
Perioperative Immunotherapy for NSCLC (ECTOP-1030)
NCT ID:
NCT06572722
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Pembrolizumab
Nivolumab
Atezolizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
atezolizumab adjuvant therapy
Arm group label:
Atezolizumab
Intervention type:
Drug
Intervention name:
Nivolumab
Description:
nivolumab neoadjuvant therapy
Arm group label:
Nivolumab
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
pembrolizumab neoadjuvant+adjuvant therapy
Arm group label:
Pembrolizumab
Summary:
This trial is a randomized, multicenter, open label phase II clinical study. The main
objective is to evaluate the efficacy of three perioperative immunotherapy modalities
(atezolizumab adjuvant therapy, nivolumab neoadjuvant therapy, pembrolizumab
neoadjuvant+adjuvant therapy) in early-stage resectable NSCLC patients. The enrolled
patients are randomly assigned in a 1:1:1 ratio to receive relevant treatment in the
three perioperative immunotherapy groups mentioned above, and undergoing short-term
pathological efficacy evaluation and long-term prognosis follow-up after surgery.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients who sign the informed consent form and are willing to complete the study
according to the plan;
2. Aged from 18 to 80 years old;
3. ECOG equals 0 or 1;
4. Not receiving lung cancer surgery before;
5. Resectable cIB-IIIA tumors;
6. Not receiving chemotherapy or radiotherapy before.
Exclusion Criteria:
1. Not cIB-IIIA tumors;
2. Nodules not suitable for resection;
3. Not lung adenocarcinoma diagnosed cytologically or pathologically;
4. Receiving lung cancer surgery before;
5. Receiving radiotherapy or chemotherapy.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
September 1, 2024
Completion date:
September 1, 2029
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06572722
