RecruitingPhase 2NCT06055465

Neoadjuvant Sacituzumab Govitecan Plus Pembrolizumab in Resectable Non-Small Cell Lung Cancer

Neoadjuvant Sacituzumab Govitecan Plus Pembrolizumab in Resectable Non-Small Cell Lung Cancer: an Open-label, Multicenter, Single Arm Phase 2 Study

Sponsor

Chinese University of Hong Kong

Enrollment

37 participants

Start Date

Feb 28, 2024

Study Type

INTERVENTIONAL

Conditions

Lung Cancer

Summary

The combination of neoadjuvant immunotherapy plus chemotherapy has recently been shown to improve survival outcome compared to chemotherapy alone and was recently approved for resectable non-small cell lung cancer (NSCLC). Despite so, recurrence risk of NSCLC after surgical resection remains high. Sacituzumab govitecan, a novel antibody drug conjugate, was demonstrated to be clinically active in metastatic NSCLC. This study aims to study the clinical efficacy of sacituzumab govitecan plus immunotherapy in resectable NSCLC. This is a open-label, single arm, multicentre, phase II study. Patients with EGFR/ALK negative, stage II-III (AJCC 8th edition), resectable NSCLC are eligible and will receive 4 cycles of neoadjuvant pembrolizumab plus sacituzumab govitecan, followed by surgical resection of tumour, and then 13 cycles of maintenance pembrolizumab.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — sacituzumab govitecan (an antibody-drug combination) and pembrolizumab (an immunotherapy) — given before surgery in people with non-small cell lung cancer (NSCLC) that can potentially be removed surgically. **You may be eligible if...** - You have been diagnosed with NSCLC confirmed by pathology - Your tumor has been tested and does not have EGFR or ALK mutations - You are at stage II or III and your tumor is considered potentially resectable (removable by surgery) - Your general health is good (ECOG score 0–1) - You are 18 years or older **You may NOT be eligible if...** - Your tumor has EGFR or ALK mutations (targeted therapy would be more appropriate) - You have already received chemotherapy or immunotherapy for this cancer - You have active autoimmune disease - Your organ function is significantly impaired Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab Govitecan

* 4 cycles, each cycle lasting for 3 weeks * 10mg/kg given every day 1 and day 8 each cycle * IV infusion

DRUGPembrolizumab

* 4 cycles, each cycle lasting for 3 weeks in Neoadjuvant phase; after surgery, 13 cycles, each cycle lasting for 3 weeks in Maintenance phase. * 200mg fixed dose every day 1 each cycle * IV infusion