Study of Treatment With Sacituzumab and Zimberelimab for Patients With Lung Cancer Confined to the Chest and Previously Operated on Who Were Not Disease-free.

Open-label, phase III, randomized, stratified (PDL1- vs PDL1+), 3 arms, multicenter clinical trial. 129 resected patients (43 per arm) with stage from IB to IIIA and IIIB (N2) non-small cell lung cancer that do not achieve pathologic complete response (pCR) after neoadjuvant treatment. This clinical trial has 3 arms of treatment. ARM 1: Observation 10 months, ARM 2: treatment with immunotherapy (Zimberelimab) for 13 cycles and ARM 3: treatment with Sacituzumab Govitecan and Zimberelimab for 8 cycles and Zimberelimab monotherapy for 5 cycles. The primary objective is to evaluate the disease-

Trial Details

NCT ID
NCT06431633
Phase
PHASE3
Sponsor
Fundación GECP
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • Zimberelimab
  • Sacituzumab govitecan
  • Cisplatin
  • Carboplatin
Locations (sample)
  • Alicante, Alicante, Spain|38.34517,-0.48149
  • Elche, Alicante, Spain|38.26218,-0.70107
  • Badalona, Barcelona, Spain|41.45004,2.24741
  • Barcelona, Barcelona, Spain|41.38879,2.15899
  • Barcelona, Barcelona, Spain|41.38879,2.15899

Key Eligibility Criteria

  • 1\. Patients diagnosed of primary non-small cell lung cancer, histologically confirmed.
  • 2\. Patients should be classified postoperatively in stage IB, IIA, IIB, IIIA or IIIB (N2) according to pathological criteria (pTNM) and according …
  • 3\. Complete surgical resection (R0) of the primary NSCLC is also essential. Surgeons are strongly advised to dissect or obtain samples of all acce…
  • 4\. The surgical intervention may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy, as determined by the responsible surgeon …

For full eligibility, visit ClinicalTrials.gov.

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