New Adjuvant Trial of Chemotherapy vs Chemo-immunotherapy (NCT04564157) | Clinical Trial Compass
Active — Not RecruitingPhase 3
New Adjuvant Trial of Chemotherapy vs Chemo-immunotherapy
Spain210 participantsStarted 2021-01-13
Plain-language summary
This is an open-label, randomised, two-arm, phase III, multi-centre clinical trial.
210 stage IB-IIIA, completely resected, non-small cell lung cancer patients will be enrolled in this trial to evaluate the disease free survival between experimental arm (Adjuvant Chemotherapy-Immunotherapy + maintenance adjuvant Immunotherapy) and control arm (Adjuvant Chemotherapy)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Patients diagnosed of primary non-small cell lung cancer, histologically confirmed
* 2\. Patients should be classified postoperatively in stage IB (=4 cm), II or IIIA according to pathological criteria and according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology.
* 3\. Complete surgical resection of the primary NSCLC is also essential. Surgeons are strongly advised to dissect or obtain samples of all accessible lymph node levels, as established in the European Society of Thoracic Surgeons guide . Consequently, at the end of the surgical intervention it is recommended to have obtained samples of a minimum of 3 (three) specific mediastinal ganglionic lobe stations (N2), one of which should include station 7, and at least one N1 station (including those resected with the tumor piece).
* 4\. The surgical intervention may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy, as determined by the responsible surgeon based on intraoperative findings. Patients who have had only segmentectomies or wedge resections are not considered eligible for participation in this study.
* 5\. Preoperative (neoadjuvant) use of platinum-based chemotherapy or other types of chemotherapy are not accepted.
* 6\. Preoperative, postoperative, or scheduled radiation therapy is not accepted for a later time. Patients with only N2 disease, who have to receive post-operative adjuvant radiotherapy wi…
What they're measuring
1
The disease-free survival
Timeframe: From the date of randomization to the date of last follow up, assessed up to 60 months