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Non-small Cell Lung CancerPhase 3NCT06080776

SH-1028 Tablets Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB NSCLC With Sensitizing EGFR Mutations

A Phase 3 study testing SH-1028 tablets in people with Non-small Cell Lung Cancer, run by Nanjing Sanhome Pharmaceutical, Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To assess the efficacy and safety of SH-1028 tablets versus placebo in stage II-IIIB non-small cell lung cancer (NSCLC) patients with sensitizing epidermal growth factor receptor (EGFR) mutations, following complete tumor resection, with or without adjuvant chemotherapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
SH-1028 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
242 participants
Where
1 siteChina
Study dates
11 May 2023to 1 Feb 2031
Phase
Phase 3
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, aged at least 18 years, younger than 75 years.
  • Histologically confirmed diagnosis of primary non-small lung cancer (NSCLC) on predominantly non-squamous histology.
  • Before surgery or randomization, MRI or CT scan of the brain and bone scan must be done to exclude metastases.
  • Complete resection (R0) and systematic lymphadenectomy are mandatory: all surgical margins must be negative for tumor, and there should be no extranodal invasion of the mediastinal lymph nodes or marginal lymph nodes.
  • Patients with postoperative pathological confirmation of stage II, IIIA and IIIB (only T3N2M0) are eligible.
  • Patients must harbor one of the two common sensitizing EGFR mutations (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M, the mutations should be confirmed by the central laboratory.
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  • Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.
  • A ECOG performance status equal to 0-1 with a minimum life expectancy of 12 weeks and no deterioration over the past 2 weeks.
  • Adequate bone marrow reserve or organ function, as demonstrated by the following laboratory values (no corrective treatment allowed within one week before blood sampling):
  • Absolute neutrophil count (ANC）≥1.5×10^9 /L
  • Platelet count ≥100×10^9 /L
  • Hemoglobin ≥90 g/L
  • Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases
  • Aspartate aminotransferase (AST) ≤ 2.5 × ULN if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases
  • Total bilirubin (TBL) ≤ 1.5 × ULN if no liver metastases or ≤ 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases
  • Creatinine ≤ 1.5 × ULN concurrent with creatinine clearance ≥ 50 mL/min (measured or calculated by the Cockcroft-Gault equation); confirmation of creatinine clearance is only required when creatinine is ≤ 1.5×ULN
  • Serum albumin (ALB) ≥28 g/L
  • Coagulation function: International standardized ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5×ULN
  • Females of child-bearing potential should be using adequate contraceptive measures throughout the study, should not be breast feeding during the study and until 6 months after treatment, and must have a negative pregnancy test prior to start of dosing.
  • Male patients should be willing to use barrier contraception during the study and until 6 months after treatment.
  • Patients must sign and date written informed consent prior to admission to the study.

Who cannot join

  • Patients with unresectable or metastatic lesions, residual lesions after surgery, or those who have had only segmentectomies or wedge resection.
  • Giant mediastinal lymph node metastasis at a single station or mediastinal lymph node fusion into a cluster at multiple stations; lesions invade the heart, aorta, esophagus, or pulmonary veins; Carcinoma of superior lung sulci.
  • Treatment with any of the following (except for standard platinum -based adjuvant chemotherapy), including any EGFR-TKI, systemic chemotherapy，immunotherapy, targeted therapy and anti-tumor traditional Chinese medicine therapy.
  • Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug.
  • The patient is currently using (or cannot discontinue at least 1 week before the first dose of study drug) a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.
  • Severe infections occurred within 4 weeks or active infections that received therapeutic intravenous or oral antibiotics within 2 weeks before the first dose.
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  • Any evidence of active infection (including hepatitis B, hepatitis C, and human immunodeficiency virus).
  • Patients received continuous steroid therapy for more than 30 days within 30 days before the first dose; require long-term (≥30 days) steroid therapy; with acquired or congenital immunodeficiency diseases or have a history of organ transplantation.
  • Severe or uncontrolled systemic diseases, including hypertension or diabetes.
  • Any of the following cardiac criteria:
  • Mean resting corrected QT interval (QTcF) > 470 msec obtained from 3 electrocardiograms (ECGs), using the Screening clinic's ECG machine and Fridericia's formula for QT interval correction.
  • Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval >250 msec).
  • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval.
  • Left ventricular ejection fraction (LVEF) <50%.
  • Receiving or requiring drugs known to prolong the QT interval or possibly cause tip torsion ventricular tachycardia during the study.
  • History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
  • History of any other malignant tumor within five years (except clinically cured cervical carcinoma in situ, basal cells or squamous epithelial skin cancer).
  • Any seriously abnormal gastrointestinal function would affect uptake, transport and absorption of the drug, such as inability to swallow the study medication, refractory nausea and vomiting, previous significant bowel resection, Recurrent diarrhea, atrophic gastritis (age < 60 years), unhealed serious gastric diseases, Crohn's disease or ulcerative colitis.
  • History of hypersensitivity to any active or inactive ingredient of SH-1028 or drug with a similar chemical structure or class to SH-1028.
  • Any severe and uncontrolled ocular disease that may, in the Investigator's opinion, present a specific risk to the patient's safety.
  • Participating in another clinical trial within 4 weeks before the first dose (excluding retrospective observational studies without intervention); within 5 half-lives of other study drugs.
  • Hepatic encephalopathy, hepatorenal syndrome, or ≥Child-Pugh grade B cirrhosis.
  • Lactating Women.
  • Any disease or condition that, in the opinion of the Investigator, would compromise the safety of the patient or interfere with study assessments.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kun Cao contact

86-15776680370

caokun@sanhome.com

China1 site, 1 recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

    Recruiting

Other trials in China

About this study

Official title: A Phase III, Double-blind, Randomised Study of SH-1028 Tablets Versus Placebo as Adjuvant Therapy in Resected Stage II-IIIB Non-Small Cell Lung Cancer With Sensitizing EGFR Mutations

To assess the efficacy and safety of SH-1028 tablets versus placebo in stage II-IIIB non-small cell lung cancer (NSCLC) patients with sensitizing epidermal growth factor receptor (EGFR) mutations, following complete tumor resection, with or without adjuvant chemotherapy.

Read the detailed description

This is a Phase III, multi-center, double-blind, randomized study assessing the efficacy and safety of SH-1028 tablets (200 mg orally, once daily) versus placebo in stage II-IIIB NSCLC with sensitizing EGFR mutations, following complete tumor resection, with or without adjuvant chemotherapy (2~4 cycles of platinum-based doublet).

Being tested
SH-1028 tablets, Placebo SH-1028 tablets
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • SH-1028 tabletsDrug

    The initial dose of SH-1028 tablets is 200 mg once daily.

  • Placebo SH-1028 tabletsDrug

    Placebo SH-1028 tablets.

Study groups in NCT06080776
Study groupRoleWhat they receive
SH-1028 tabletsExperimentalNot described
Receives: Drug: SH-1028 tablets
Placebo SH-1028 tabletsPlacebo comparatorNot described
Receives: Drug: Placebo SH-1028 tablets

What is being measured

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

  1. Disease free survival (DFS) assessed by Independent Review Committee (IRC)

    Disease-free survival is defined as the time from randomization until the date of the recurrence of tumor or death. The primary endpoint of DFS was based on the assessment of IRC.

    Measured: From the time of randomization to the recurrence of tumor or death, through study completion, an average of 5 years

Secondary outcomes (6)

  1. Disease free survival (DFS) assessed by investigators

    The secondary endpoint of DFS was based on the assessment of investigators.

    Measured: From the time of randomization to the recurrence of tumor or death, through study completion, an average of 5 years

  2. DFS rate at 2, 3 and 5 years assessed by IRC

    DFS rate at 2, 3 and 5 years is defined as the proportion of patients alive and disease free at 2, 3 and 5 years, respectively.

    Measured: From the time of randomization to the recurrence of tumor or death, up to 5 years

  3. Overall survival (OS)

    Overall survival is defined as the time from the date of randomization until death from any cause.

    Measured: From the time of randomization to death, through study completion, an average of 5 years

  4. OS rate at 5 years

    OS rate at 5 years is defined as the proportion of patients alive at 5 years.

    Measured: From the time of randomization to death, up to 5 years

  5. Incidence rate of adverse events (AEs)

    AEs are assessed according to CTCAE v5.0.

    Measured: From the screening period to 28 days after treatment discontinuation

  6. Plasma concentrations of SH-1028 and its major metabolites

    This is defined as the pharmacokinetics parameters derived from plasma concentrations of SH-1028 and its metabolites, Imp2 and Imp3.

    Measured: The specified time points of blood sampling, up to 36 weeks

Timeline

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

  1. First posted12 Oct 2023
  2. Study start11 May 2023
  3. Primary completion1 Feb 2028 (estimated)
  4. Study completion1 Feb 2031 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
242 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06080776
Sponsor's protocol ID
SHC013-III-02
Status last verified
Oct 2023
First submitted
8 Aug 2023
Last updated
12 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SH-1028 tablets in people with Non-small Cell Lung Cancer, run by Nanjing Sanhome Pharmaceutical, Co., Ltd. at 1 site in China.

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 21 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Contact Kun Cao (86-15776680370, caokun@sanhome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease free survival (DFS) assessed by Independent Review Committee (IRC) (time frame: From the time of randomization to the recurrence of tumor or death, through study completion, an average of 5 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 NCT06080776.

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 12 Oct 2023.

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