Non-Small Cell Lung CancerPhase 2NCT03823807
A Study to Evaluate the Safety and Efficacy of SH-1028 in Locally Advanced or Metastatic NSCLC
A Phase 2 study testing SH-1028 in people with Non-Small Cell Lung Cancer, run by Nanjing Sanhome Pharmaceutical, Co., Ltd..
Trial summary
A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of SH-1028 with Locally Advanced/Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- SH-1028
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Mar 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years, both sexes.
- Histological or cytological confirmation of metastatic or locally advanced, relapsed NSCLC that are not candidates for curative treatment.
- Confirmation that the tumor harbors an EGFR mutation known to be associated with EGFR-TKI sensitivity (including exon 19 deletion, L858R, L861Q, G719X or dual mutation) for treatment-naive NSCLC patients (without systemic therapy or with relapse after previous surgery; patients with locally treatment for non-target lesions are accepted ).(This criteria applies to treatment-naïve NSCLC patients in Part B).
- Patients must have confirmation of T790M+ mutation status, which have experienced disease progression while on a previous continuous treatment with an EGFR-TKI or clinical benefit from EGFR-TKI according to the Jackman criteria while on continuous treatment with an EGFR-TKI (PR/CR, or SD continued ≥6 months); Patients can receive more than one line of systemic therapy. (This criteria applies to EGFR-T790M+ patients in Part A and Part B).
- ECOG score of 0-2 with a minimum life expectancy of 3 months.
- At least 1 lesion that has not previously been irradiated, that can be accurately measured at Baseline as ≥ 10mm in the longest diameter (except lymph nodes which must have short axis ≥ 15mm) with computerized tomography (CT) or magnetic resonance imaging (MRI), which is suitable for accurately repeated measurements.
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- Adequate bone marrow reserve or organ function as demonstrated by the following laboratory values: a) absolute neutrophil count ≥ 1.5×109/L; b) platelet count ≥ 100×109/L; c) hemoglobin ≥ 90 g/L; d) ALT ≤ 2.5×ULN if no demonstrable liver metastases, or ALT ≤ 5×ULN in the presence of liver metastases; e) AST ≤ 2.5×ULN if no demonstrable liver metastases, or AST ≤ 5×ULN in the presence of liver metastases; f) Total bilirubin ≤ 1.5×ULN if no liver metastases or ≤ 3×ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases; g) Creatinine ≤ 1.5×ULN, or Creatinine > 1.5×ULN concurrent with creatinine clearance ≥ 50 ml/min (measured or calculated by the Cockcroft- Gault equation).
- 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 completion of study, 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 completion of study (i.e., condoms).
- Do not anticipate other clinical trial in 1 month.
- Patients must sign and date written informed consent prior to admission to the study.
Who cannot join
- EGFR-TKI treatment within 8 days or approximately 5 times the half-life of the specific drug, whichever is longer, of the first dose study.
- Any cytotoxic chemotherapy or immunological therapy used for a previous treatment regimen or clinical study within 21 days of the first dose of study treatment; Any target therapy(except EGFR-TKIs)and endocrine therapy used for a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
- Ever used the third generation EGFR-TKI, such as Osimertinib, CO-1686, Avitinib, AST2818, HS-10296.
- Major surgery within 4 weeks of the first dose of study treatment.
- Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation which must be completed within 4 weeks of the first dose of study treatment.
- The patient is currently using (or cannot discontinue at least 1 week before the first dose of study treatment) a drug or herbal supplement known as a potent inhibitor or inducer of CYP3A4.
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- Use large doses of glucocorticoids (eg, >10 mg/day prednisone ) or other immunosuppressive agents within 4 weeks.
- Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE), Grade 1, at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.
- Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids , anticonvulsants and mannitol for at least 4 weeks prior to start of study treatment.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension or active bleeding diatheses, which, in the Investigator's opinion, makes it undesirable for the patient to participate in the trial.
- Active infection (e.g., hepatitis B, hepatitis C or human immunodeficiency virus [HIV]). (HBsAg is positive but HBV-DNA < ULN ,and HCVAb is positive but HCV-RNA<ULN can be accepted.）.
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 electrocardiograms (ECGs), using the Screening clinic 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).
- Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
- Have 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 to a drug with a similar chemical structure or class to SH-1028.
- Women who are breast feeding.
- 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
No sites are listed yet.
About this study
Official title: A Multicenter, Open-label, Phase II Study to Evaluate the Safety and Efficacy of SH-1028 in Locally Advanced or Metastatic NSCLC
A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of SH-1028 with Locally Advanced/Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene.
Read the detailed description
This is a multicenter, open-label, phase II study to evaluate the safety and efficacy of SH-1028 in locally advanced or metastatic NSCLC.The trail is divided into two parts:part A is dose extension phase,and Part B is expand sample size phase to confirm the efficacy of SH-1028.Patients must agree to provide a biopsy for central confirmation of T790M mutation status following confirmed disease progression on the most recent treatment regimen. The primary objective of the study is to assess the efficacy of SH-1028 by assessment of Objective Response Rate according to RECIST 1.1 by an Independent Central Review.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- SH-1028
- 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-1028Drug
Oral,100mg or 200mg ,QD, fasted
| Study group | Role | What they receive |
|---|---|---|
| SH-1028 | Experimental | QD,Oral Receives: Drug: SH-1028 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: Every 2 cycles (21 days for 1 cycle) until end of treatment, an average of 1 year.
Secondary outcomes (7)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: From Baseline up to 30 days after the last dose, an average of 1 year.
Maximum Plasma Concentration (Cmax）
Measured: Part A: Day 1 of Cycle 1 and 2 (21 days for 1 cycle).
Area Under the Curve [AUC]
Measured: Part A: Day 1 of Cycle 1 and 2 (21 days for 1 cycle).
Progression-free survival (PFS)
Measured: Every 2 cycles (21 days for 1 cycle) until end of follow-up, an average of 1 year.
Duration of Response(DOR)
Measured: Every 2 cycles (21 days for 1 cycle) until end of treatment, an average of 1 year.
Disease Control Rates(DCR)
Measured: Every 2 cycles (21 days for 1 cycle) until end of treatment, an average of 1 year.
Overall survival(OS)
Measured: Every 2 cycles (21 days for 1 cycle) until end of treatment; Every 12 weeks until end of follow-up, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study startMar 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823807
- Sponsor's protocol ID
- SHC013-II-01
- Status last verified
- Jan 2019
- First submitted
- 22 Jan 2019
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase II Study to Evaluate the Safety and Efficacy of SH-1028 in Locally Advanced or Metastatic NSCLC
- ClinicalTrials.gov ID
- NCT03823807
- Acronym / sponsor ID
- SHC013-II-01
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of SH-1028 with Locally Advanced/Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene.
Detailed description
This is a multicenter, open-label, phase II study to evaluate the safety and efficacy of SH-1028 in locally advanced or metastatic NSCLC.The trail is divided into two parts:part A is dose extension phase,and Part B is expand sample size phase to confirm the efficacy of SH-1028.Patients must agree to provide a biopsy for central confirmation of T790M mutation status following confirmed disease progression on the most recent treatment regimen. The primary objective of the study is to assess the efficacy of SH-1028 by assessment of Objective Response Rate according to RECIST 1.1 by an Independent Central Review.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SH-1028 | Experimental | Drug: SH-1028QD,Oral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years, both sexes.
- Histological or cytological confirmation of metastatic or locally advanced, relapsed NSCLC that are not candidates for curative treatment.
- Confirmation that the tumor harbors an EGFR mutation known to be associated with EGFR-TKI sensitivity (including exon 19 deletion, L858R, L861Q, G719X or dual mutation) for treatment-naive NSCLC patients (without systemic therapy or with relapse after previous surgery; patients with locally treatment for non-target lesions are accepted ).(This criteria applies to treatment-naïve NSCLC patients in Part B).
- Patients must have confirmation of T790M+ mutation status, which have experienced disease progression while on a previous continuous treatment with an EGFR-TKI or clinical benefit from EGFR-TKI according to the Jackman criteria while on continuous treatment with an EGFR-TKI (PR/CR, or SD continued ≥6 months); Patients can receive more than one line of systemic therapy. (This criteria applies to EGFR-T790M+ patients in Part A and Part B).
- ECOG score of 0-2 with a minimum life expectancy of 3 months.
Key exclusion criteria (20 listed)
- EGFR-TKI treatment within 8 days or approximately 5 times the half-life of the specific drug, whichever is longer, of the first dose study.
- Any cytotoxic chemotherapy or immunological therapy used for a previous treatment regimen or clinical study within 21 days of the first dose of study treatment; Any target therapy(except EGFR-TKIs)and endocrine therapy used for a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
- Ever used the third generation EGFR-TKI, such as Osimertinib, CO-1686, Avitinib, AST2818, HS-10296.
- Major surgery within 4 weeks of the first dose of study treatment.
- Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation which must be completed within 4 weeks of the first dose of study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SH-1028Oral,100mg or 200mg ,QD, fasted | Drug | SH-1028 |
Primary outcome
Objective Response Rate (ORR)
Time frame: Every 2 cycles (21 days for 1 cycle) until end of treatment, an average of 1 year.
7 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: From Baseline up to 30 days after the last dose, an average of 1 year.
Maximum Plasma Concentration (Cmax）
Time frame: Part A: Day 1 of Cycle 1 and 2 (21 days for 1 cycle).
Area Under the Curve [AUC]
Time frame: Part A: Day 1 of Cycle 1 and 2 (21 days for 1 cycle).
Progression-free survival (PFS)
Time frame: Every 2 cycles (21 days for 1 cycle) until end of follow-up, an average of 1 year.
Duration of Response(DOR)
Time frame: Every 2 cycles (21 days for 1 cycle) until end of treatment, an average of 1 year.
Disease Control Rates(DCR)
Time frame: Every 2 cycles (21 days for 1 cycle) until end of treatment, an average of 1 year.
Overall survival(OS)
Time frame: Every 2 cycles (21 days for 1 cycle) until end of treatment; Every 12 weeks until end of follow-up, an average of 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SH-1028 in people with Non-Small Cell Lung Cancer, run by Nanjing Sanhome Pharmaceutical, Co., Ltd..
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 11 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caicun Zhou, MD (+86-13301825532, caicunzhoudr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Every 2 cycles (21 days for 1 cycle) until end of treatment, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2019.