Locally Advanced or Metastatic Non-Small Cell Lung CancerPhase 2NCT05863325
A Study to Compare the Efficacy and Safety of HB1801 to Taxotere in Advanced Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing HB1801 and Taxotere in people with Locally Advanced or Metastatic Non-Small Cell Lung Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, randomized, positive drug-controlled Phase Ⅱ clinical study to compare the efficacy and safety of HB1801 to Taxotere in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed platinum- containing chemotherapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- What is being tested?
- HB1801 and Taxotere
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 27 Jun 2023to Sep 2024
- 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 old.
- Voluntarily signed written informed consent form, willing and able to comply with scheduled visits and treatment and laboratory tests of the protocol.
- Patient has a diagnosis of locally advanced or metastatic NSCLC as determined by histological or cytological results.
- Patients with known EGFR-sensitive mutation /ALK fusion /ROS1 fusion must have been documented disease progression during or after targeted drugs treatments and platinum-containing chemotherapies; Patients without above positive genes must have been documented disease progression during or after PD-1/PD-L1 inhibitors treatments and platinum-containing chemotherapies (combined or sequential). Note: For prior adjuvant/neoadjuvant treatment with platinum-containing regimens of chemotherapy, progression during or within 6 months of completion of adjuvant/neoadjuvant treatment may be considered a failure of platinum-containing chemotherapy.
- At least one measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- Adequate organ function.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Patients of reproductive potential must be willing to use adequate contraception during the study and through 6 months after the last dose of study treatment.
Who cannot join
- Prior use of docetaxel monotherapy or combination therapy for metastatic disease.
- Known ≥ grade 3 hypersensitivity and/or contraindications to human albumin or docetaxel; known allergy and/or contraindications to glucocorticoids (including but not limited to active digestive tract ulcers, severe hypertension, severe hypokalemia, glaucoma, etc.).
- Leptomeningeal metastases and/or untreated active brain metastases; if the patient's brain metastases have been treated, a stable state is required prior to randomization (no radiographically confirmed progression and normal return of all neurologically relevant symptoms within 4 weeks prior to randomization), no new brain metastases or enlargement of the original brain metastases are shown on radiographs, and steroid hormone therapy is not required for at least 7 days prior to randomization.
- History of other malignancies within 3 years prior to randomization, excluding basal cell or squamous cell carcinoma of skin and cervical carcinoma in situ that have been radically treated.
- Serosal effusion requiring drainage or diuretic treatment (such as pleural effusion, peritoneal effusion, or pericardial effusion) within 2 weeks before randomization.
- History of severe cardiovascular disease within 6 months prior to randomization, including but not limited to:
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- （1) Uncontrolled hypertension (defined as persistent systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg despite the use of antihypertensive medications); （2) Severe arrhythmias and conduction abnormalities requiring treatment with antiarrhythmic agents other than beta-blockers or digoxin (except atrial fibrillation and paroxysmal supraventricular tachycardia); （3) History of myocardial infarction, unstable angina pectoris, angioplasty, and coronary artery bridging surgery; （4) Heart failure, New York Heart Association (NYHA)≥grade 3; （5) QTcF > 480 ms; （6) Other heart diseases that investigators identify as clinically significant. 7. Active infection treated with intravenous antibiotics within 2 weeks prior to randomization.
- 8. Patients who have undergone major organ surgery (excluding needle biopsy) within 4 weeks prior to randomization or who will require elective surgery during the trial period.
- 9. The toxicity of previous anti-tumor therapy does not return to grade≤1 (CTCAE v5.0), except for grade 2 neuropathy, alopecia, hypothyroidism caused by prior anti-tumor therapy (including hormone replacement therapy), and toxicity judged by the investigator to be of no safety risk.
- 10. Receiving antitumor therapy such as chemotherapy, targeted therapy, immunotherapy, and other investigational agents within 4 weeks or 5 half-lives (whichever is shorter but at least 2 weeks) prior to randomization, other conditions as follows: Received radiotherapy within 2 weeks prior to randomization, or received radiotherapy prior to 2 weeks of randomization but patient has not recovered from all acute toxicity and requires hormone therapy; Chinese medicines with anti-tumor indications administered within 2 weeks prior to randomization.
- 11. Use of potent inhibitors or potent inducers of CYP3A4 within 2 weeks prior to randomization.
- 12. Life expectancy < 3 months. 13. HBsAg/HBcAb positive with HBV-DNA ≥ 10^2 cps/mL or ≥ 2000 IU/mL); hepatitis C antibody-positive with a positive PCR result for HCV RNA; Patients infected with human immunodeficiency virus (HIV); Patients with active tuberculosis.
- 14. Patients are not suitable for the study in the investigator's opinion, include but are not limited to, conditions in which the patient has a serious or uncontrolled medical condition, interferes with the interpretation of the study results, and interferes with compliance with the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jilin Provincial Tumor Hospital
Changchun, Jilin
Ying Cheng, +86-0331-69085587
About this study
Official title: An Open-label, Randomized, Positive Drug-controlled Phase Ⅱ Study to Compare the Efficacy and Safety of HB1801 to Taxotere in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
This is an open-label, randomized, positive drug-controlled Phase Ⅱ clinical study to compare the efficacy and safety of HB1801 to Taxotere in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed platinum- containing chemotherapies.
Read the detailed description
Eligible patients will enter the screening period up to 28 days before the start of treatment. Patients will be randomized in a 1:1 ratio to receive HB1801 (trial group) or Taxotere (control group). Randomized stratification factor is pathological type (squamous vs. non-squamous). Patients in trial group will receive HB 1801 and patients in control group will receive Taxotere. HB 1801 or Taxotere will be given on the first day of each cycle (21 days). Each patient will be treated until documented disease progression, discontinuation due to toxicity, withdrawal of consent, initiation of a new antitumor therapy, loss of follow-up, death, or study completion, whichever occurs first.
- Being tested
- HB1801, Taxotere
- 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.
HB1801Drug
HB1801 will be administered by intravenous (IV) injections on the first day of each cycle.
TaxotereDrug
Taxotere will be administered by intravenous (IV) injections on the first day of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| HB1801 | Experimental | HB1801 will be given in 21-day cycles until documented disease progression, discontinuation due to toxicity, withdrawal of consent, initiation of a new antitumor therapy, loss of follow-up, death, or study completion, whichever occurs first. Receives: Drug: HB1801 |
| Taxotere | Active comparator | Taxotere will be given in 21-day cycles until documented disease progression, discontinuation due to toxicity, withdrawal of consent, initiation of a new antitumor therapy, loss of follow-up, death, or study completion, whichever occurs first. Receives: Drug: Taxotere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Measured: up to approximately 3 years
Secondary outcomes (6)
Progression-free Survival（PFS）
Measured: up to approximately 3 years
Disease Control Rate（DCR）
Measured: up to approximately 3 years
Duration of Response (DoR)
Measured: up to approximately 3 years
Overall Survival (OS)
Measured: up to approximately 3 years
Frequency and Severity of Adverse Events During Treatment
Measured: up to approximately 3 years
Total and Free Docetaxel Concentrations in Plasma
Measured: The first cycle (21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start27 Jun 2023
- Primary completionMar 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ying Cheng, Principal investigator, Jilin Provincial Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863325
- Sponsor's protocol ID
- HB1801-009
- Status last verified
- Nov 2023
- First submitted
- 8 May 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Positive Drug-controlled Phase Ⅱ Study to Compare the Efficacy and Safety of HB1801 to Taxotere in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05863325
- Acronym / sponsor ID
- HB1801-009
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 18 May 2023 (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.
This is an open-label, randomized, positive drug-controlled Phase Ⅱ clinical study to compare the efficacy and safety of HB1801 to Taxotere in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed platinum- containing chemotherapies.
Detailed description
Eligible patients will enter the screening period up to 28 days before the start of treatment. Patients will be randomized in a 1:1 ratio to receive HB1801 (trial group) or Taxotere (control group). Randomized stratification factor is pathological type (squamous vs. non-squamous). Patients in trial group will receive HB 1801 and patients in control group will receive Taxotere. HB 1801 or Taxotere will be given on the first day of each cycle (21 days). Each patient will be treated until documented disease progression, discontinuation due to toxicity, withdrawal of consent, initiation of a new antitumor therapy, loss of follow-up, death, or study completion, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HB1801 | Experimental | Drug: HB1801HB1801 will be given in 21-day cycles until documented disease progression, discontinuation due to toxicity, withdrawal of consent, initiation of a new antitumor therapy, loss of follow-up, death, or study completion, whichever occurs first. |
| Taxotere | Active comparator | Drug: TaxotereTaxotere will be given in 21-day cycles until documented disease progression, discontinuation due to toxicity, withdrawal of consent, initiation of a new antitumor therapy, loss of follow-up, death, or study completion, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age≥18 years old.
- Voluntarily signed written informed consent form, willing and able to comply with scheduled visits and treatment and laboratory tests of the protocol.
- Patient has a diagnosis of locally advanced or metastatic NSCLC as determined by histological or cytological results.
- Patients with known EGFR-sensitive mutation /ALK fusion /ROS1 fusion must have been documented disease progression during or after targeted drugs treatments and platinum-containing chemotherapies; Patients without above positive genes must have been documented disease progression during or after PD-1/PD-L1 inhibitors treatments and platinum-containing chemotherapies (combined or sequential). Note: For prior adjuvant/neoadjuvant treatment with platinum-containing regimens of chemotherapy, progression during or within 6 months of completion of adjuvant/neoadjuvant treatment may be considered a failure of platinum-containing chemotherapy.
- At least one measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Key exclusion criteria (13 listed)
- Prior use of docetaxel monotherapy or combination therapy for metastatic disease.
- Known ≥ grade 3 hypersensitivity and/or contraindications to human albumin or docetaxel; known allergy and/or contraindications to glucocorticoids (including but not limited to active digestive tract ulcers, severe hypertension, severe hypokalemia, glaucoma, etc.).
- Leptomeningeal metastases and/or untreated active brain metastases; if the patient's brain metastases have been treated, a stable state is required prior to randomization (no radiographically confirmed progression and normal return of all neurologically relevant symptoms within 4 weeks prior to randomization), no new brain metastases or enlargement of the original brain metastases are shown on radiographs, and steroid hormone therapy is not required for at least 7 days prior to randomization.
- History of other malignancies within 3 years prior to randomization, excluding basal cell or squamous cell carcinoma of skin and cervical carcinoma in situ that have been radically treated.
- Serosal effusion requiring drainage or diuretic treatment (such as pleural effusion, peritoneal effusion, or pericardial effusion) within 2 weeks before randomization.
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 |
|---|---|---|
| HB1801HB1801 will be administered by intravenous (IV) injections on the first day of each cycle. | Drug | HB1801 |
| TaxotereTaxotere will be administered by intravenous (IV) injections on the first day of each cycle. | Drug | Taxotere |
Primary outcome
Overall Response Rate (ORR)
Time frame: up to approximately 3 years
6 secondary outcomes
Progression-free Survival（PFS）
Time frame: up to approximately 3 years
Disease Control Rate（DCR）
Time frame: up to approximately 3 years
Duration of Response (DoR)
Time frame: up to approximately 3 years
Overall Survival (OS)
Time frame: up to approximately 3 years
Frequency and Severity of Adverse Events During Treatment
Time frame: up to approximately 3 years
Total and Free Docetaxel Concentrations in Plasma
Time frame: The first cycle (21 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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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.
Ying Cheng principal investigator
Jilin Provincial Tumor Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HB1801 and Taxotere in people with Locally Advanced or Metastatic Non-Small Cell Lung Cancer, run by CSPC ZhongQi Pharmaceutical Technology 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 8 inclusion and 13 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 7 Nov 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. 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 Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: up to approximately 3 years). 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 7 Nov 2023.