Neoadjuvant Sacituzumab Govitecan Plus Pembrolizumab in Resectable Non-Small Cell Lung Cancer (NCT06055465) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Neoadjuvant Sacituzumab Govitecan Plus Pembrolizumab in Resectable Non-Small Cell Lung Cancer
Hong Kong37 participantsStarted 2024-02-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female or male patients, 18 years of age or older, able to understand and give written informed consent
. Pathologically proven NSCLC
. Tumour tested negative for EGFR and ALK
. Measurable disease by CT as per RECIST Version 1.1 criteria by investigator
. Tumour tissue is available for translational research (preferably histology, cytology allowed)
. AJCC 8th edition Stage II-III based on the following diagnostic workup and tumour is considered potentially resectable
. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial combining sacituzumab govitecan and pembrolizumab before surgery — what does that mean for how much safety and effectiveness data already exists for this specific combination in lung cancer?
2The trial is no longer enrolling new patients — does that mean I've missed the window to participate, and are there similar neoadjuvant trials I might still be eligible for?
3Since the main goal is achieving a pathological complete response — meaning no detectable cancer in the tissue removed during surgery — how does that outcome compare to what I might expect from standard neoadjuvant treatment options?
4Sacituzumab govitecan is an antibody-drug conjugate that delivers chemotherapy directly to cancer cells — what side effects should I be aware of, and how might they interact with the immunotherapy pembrolizumab in terms of my overall health going into surgery?
5Given that this approach uses two treatments before surgery rather than surgery first, what would happen if my tumor didn't respond well enough — would I still be a candidate for surgery, or could that window close?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pathological complete response (pCR) rate in the intention-to-treat population
. Adequate haematological values without transfusional or growth factor support within 2 weeks of study drug initiation: haemoglobin ≥ 9.0g/dL, absolute neutrophil count ≥ 1.5 x 10\^9/L, platelet count ≥ 100 x 10\^9/L
Exclusion criteria
. Presence of any distant metastasis
. Previous or concomitant malignancy within 5 years prior registration with the exception of adequately treated localized non-melanoma skin cancer or cervical carcinoma in situ. Prior anti-cancer treatment can be accepted except for drugs listed in exclusion criteria (3) to (8)
. Received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study treatment Day 1
. Mixed SCLC and NSCLC histology
. Any previous treatment with a PD-1 or PD-L1 or CTLA4 inhibitor, or another agent directed to stimulatory or coinhibitory T-cell receptor (OX40, CD137, etc)
. Any previous treatment with sacituzumab govitecan, topoisomerase inhibitor, or TROP-2 targeted therapy.
. Previous radiotherapy to the chest including radiation to mediastinal tumours (e.g. germ cell tumours and thymic tumours)
. Positive pregnancy test by urine or serum (Appendix V) or women who are breastfeeding