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Lung CancerPhase 2NCT06055465

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

A Phase 2 study testing Sacituzumab Govitecan and Pembrolizumab in people with Lung Cancer, run by Chinese University of Hong Kong at 4 sites in Hong Kong.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Sacituzumab Govitecan and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
4 sitesHong Kong
Study dates
28 Feb 2024to 30 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • Distant metastasis staging by PET/CT whole body or CT thorax and upper abdomen with contrast
  • Patients with stage IIIB (N2) that is considered potentially resectable by cardiothoracic surgeon may be enrolled
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  • 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
  • Adequate hepatic function: bilirubin ≤ 1.5 x ULN, AST/ALT ≤ 2.5 x ULN
  • Adequate renal function: calculated creatinine clearance ≥ 30 ml/min, according to the formula of Cockcroft-Gault equation
  • Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix V.
  • Patients with HBV (HBsAg +ve) must be on antiviral therapy and have a well-controlled HBV infection as determined by investigator. Patients who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease. Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.
  • Patients with known HCV infection (positive hepatitis C antibody) (testing is not mandatory for trial enrolment) must have been treated with antiviral therapy and have undetectable HCV viral load.
  • Willing and able to comply with the requirements and restrictions in this protocol.

Who cannot join

  • 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.
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  • 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
  • Known hypersensitivity to pembrolizumab or Sacituzumab govitecan, or their metabolites or formulation excipient
  • Requirement for ongoing therapy with or prior use of any prohibited medications listed in Appendix IV
  • Absolute contraindications for the use of corticosteroids as premedication
  • Concurrent treatment with other experimental drugs or other anticancer therapy, treatment in a clinical trial within 30 days prior to registration
  • Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment
  • Current or prior use of immunosuppressive medication within 28 days before the first dose of pembrolizumab or sacituzumab govitecan, with the exceptions of intranasal and inhaled corticosteroid or systemic corticosteroids at physiological doses (i.e. which must not exceed 10mg/day of prednisone or an equivalent corticosteroid) and the premedication for chemotherapy.
  • Severe or uncontrolled cardiac disease, congestive heart failure NYHA class III or IV, unstable angina pectoris, history of myocardial infarction during the last 3 months, serious arrhythmias requiring medication (with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia under medical control); history of QTc interval prolongation
  • Clinically severe pulmonary compromise resulting from intercurrent pulmonary illness including, but not limited to, any underlying pulmonary disorder (ie pulmonary embolism within 3 months of enrolment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.); history of (non-infectious) pneumonitis that required steroids or recurrent pneumonitis; any autoimmune/connective tissue/inflammatory disorders with pulmonary involvement, or prior pneumonectomy.
  • Active autoimmune disease requiring systemic treatment within the past 2 years or a documented history of clinically severe autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents with the exception of resolved childhood asthma/atopy, hypothyroidism or adrenal insufficiency on hormone replacement, diabetes mellitus stable on insulin replacement
  • Active HBV or HCV infection
  • Known history of Human Immunodeficiency Virus (HIV).
  • History of primary immunodeficiency
  • History of allogeneic organ transplant
  • Receipt of live attenuated vaccination any time during trial therapy and within 30 days of receiving the last dose of trial therapy. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed. COVID-vaccination is allowed.
  • Any concomitant drugs contraindicated for use with pembrolizumab or sacituzumab govitecan including systemic corticosteroid, methotrexate, azathioprine, TNF-alpha blockers.
  • Any other serious underlying medical, psychiatric, psychological, familial condition that in the judgement of the investigator, that may interfere with planned staging, treatment and follow up, affect patient compliance, or place the patient at high risk from treatment-related complications.
  • Patients who refuse surgical treatment of the lung cancer

Trial locations and contacts

4 sites in 1 country.

Hong Kong4 sites

  • Department of Clinical Oncology, Prince of Wales Hospital

    Hong Kong

  • Department of Clinical Oncology, Queen Elizabeth Hospital

    Hong Kong

  • Department of Clinical Oncology, Tuen Mun Hospital

    Hong Kong

  • Department of Oncology, Princess Margaret Hospital

    Hong Kong

Other trials in Hong Kong

About this study

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

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.

Conditions
Lung Cancer
Being tested
Sacituzumab Govitecan, Pembrolizumab
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab GovitecanDrug

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

  • PembrolizumabDrug

    • 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
Study groups in NCT06055465
Study groupRoleWhat they receive
Sacituzumab Govitecan and PembrolizumabExperimental* Neoadjuvant treatment with pembrolizumab and sacituzumab govitecan is given for a total for 4 cycles. Pembrolizumab is administered first on day 1 every cycle. Sacituzumab govitecan is administered second on day 1 and 8 every cycle. The next cycle should start a minimum 14 days after the Day 8 dose. * Surgery is to be performed within 4-8 weeks after day 1 of last cycle of neoadjuvant pembrolizumab/SG. * Postoperative radiotherapy is recommended for patients with R1/R2 resection. * Maintenance treatment with pembrolizumab alone is given for a total for 13 cycles. This is to be started within 4-8 weeks after surgery or within 4 weeks after postoperative radiotherapy.
Receives: Drug: Sacituzumab Govitecan; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response (pCR) rate in the intention-to-treat population

    Measured: 2 years

Secondary outcomes (10)

  1. Resection rate after neoadjuvant SG and pembrolizumab combination: proportion of patients who undergo surgery with curative intent

    Measured: 2 years

  2. pCR rates in patients who undergo surgery

    Measured: 2 years

  3. Major pathological response (MPR) rate in the ITT population and in patients who undergo surgery: MPR is defined as less than 10% viable tumor cells in resected primary tumour specimen

    Measured: 2 years

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 while on neoadjuvant SG and pembrolizumab combination

    Measured: 2 years

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 while on adjuvant pembrolizumab

    Measured: 2 years

  6. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 first 30 days after surgery

    Measured: 2 years

  7. Objective response rate (ORR): rate of partial and complete response on CT scans according to RECIST criteria ver 1.1

    Measured: 2 years

  8. Overall Survival

    Measured: 2 years

  9. 12 month and 24 month event-free survival (EFS) rate

    Measured: 2 years

  10. Patient reported quality of life (QOL), as measured by EQ-5D-3L during study treatment.

    For the descriptive system of EQ-5D-3L, three levels of problems are described in each dimension. For the Visual Analogue Scale (VAS), the overall health assessment of the respondent is captured, ranging from 0 (worst health imaginable) to 100 (best health imaginable)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2023
  2. Study start28 Feb 2024
  3. Primary completion30 Dec 2028 (estimated)
  4. Study completion30 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06055465
Sponsor's protocol ID
LUN109
Status last verified
Jun 2026
First submitted
24 Aug 2023
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab Govitecan and Pembrolizumab in people with Lung Cancer, run by Chinese University of Hong Kong at 4 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) rate in the intention-to-treat population (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06055465.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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