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Non-small Cell Lung AdenocarcinomaPhase 3NCT05943795

A Clinical Study of SI-B001 Combined With Docetaxel in the Treatment of Non-small Cell Lung Adenocarcinoma and Lung Squamous Cell Carcinoma

A Phase 3 study testing SI-B001 and Docetaxel in people with Non-small Cell Lung Adenocarcinoma and Squamous Cell Carcinoma of Lung, run by Sichuan Baili Pharmaceutical Co., Ltd. at 2 sites in China.

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

Main objectives: To evaluate the benefit of SI-B001+ docetaxel on overall survival (OS) of bidotaxel. To evaluate the benefit of SI-B001+ Docetaxel over Docetaxel's progression-free survival (PFS) based assessment. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
SI-B001 and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
589 participants
Where
2 sitesChina
Study dates
14 Jul 2023to Jul 2026
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign the informed consent form voluntarily and follow the protocol requirements;
  • Gender is not limited;
  • Age ≥18 years old and ≤80 years old;
  • Expected survival time ≥3 months;
  • Patients with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer;
  • Subjects had to consent to complete ctDNA testing during the screening period;
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  • At least one measurable lesion meeting the RECIST v1.1 definition was required;
  • ECOG 0 or 1;
  • The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
  • No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
  • No blood transfusion is allowed within 14 days before the first use of the study drug, and the organ function level must meet the requirements on the premise that albumin and colony-stimulating factor are not allowed;
  • Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
  • Proteinuria ≤2+ or < 1000mg/24h;
  • For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.

Who cannot join

  • Patients with previous docetaxel use;
  • Patients with non-small cell lung cancer (NSCLC) confirmed by histology or cytology except lung squamous cell carcinoma and lung adenocarcinoma;
  • The patients had received chemotherapy or biological therapy within 4 weeks or 5 half-lives before the first dose, and had received palliative radiotherapy or modern traditional Chinese medicine approved by NMPA for anti-tumor treatment within 2 weeks;
  • The history of severe cardiovascular and cerebrovascular diseases within six months before screening;
  • Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
  • Complicated with pulmonary diseases leading to severe impairment of lung function;
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  • Active autoimmune and inflammatory diseases;
  • Other malignancies diagnosed within 5 years before the first dose;
  • Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \&gt; 150 mmHg or diastolic blood pressure \&gt; 100 mmHg);
  • Patients with previous or current clinical manifestations or high risk factors such as ILD, drug-associated pneumonia, and radiation pneumonitis;
  • With untreated central nervous system metastases and/or carcinomatous meningitis/or spinal cord compression;
  • Patients with a history of allergy to the recombinant humanized or human-mouse chimeric antibody or to SI-B001 or any of the excipients of the chemotherapy drugs used in this trial;
  • Had a history of autologous or allogeneic stem cell transplantation or organ transplantation;
  • Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;
  • Serious infection within 4 weeks before the first dose of study drug;
  • Pleural, pericardial, or abdominal effusion requiring drainage and/or associated with symptoms within 4 weeks before the first dose of study drug;
  • Received other investigational drugs or treatments within 4 weeks before the first dose;
  • A history of severe neurological or psychiatric illness;
  • Imaging examination showed that the tumor had invaded or wrapped the large thoracic vessels or pericardium or heart;
  • Serious unhealed wound, ulcer or fracture within 4 weeks before signing the informed consent;
  • Patients had hemoptysis or hemoptysis within 4 weeks before signing the informed consent, but those with blood in sputum were not excluded;
  • Had severe infusion reactions (CTCAE grade ≥3) to antibody therapy;
  • Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
  • History of intestinal obstruction, inflammatory bowel disease, extensive bowel resection or chronic diarrhea;
  • Who are scheduled to receive the live vaccine or who receive it within 30 days before the first dose;
  • The investigator did not consider it appropriate to apply other criteria for participation in the trial.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

Other trials in China

About this study

Official title: A Phase III Clinical Study of SI-B001 Combined With Docetaxel Second-line Therapy in Patients With Non-small Cell Lung Adenocarcinoma and Lung Squamous Cell Carcinoma Without Actionable Genomic Alterations Who Failed Only First-line Treatment With PD-1/PD-L1 Monoclonal Antibody Plus Platinum-Based Chemotherapy

Main objectives: To evaluate the benefit of SI-B001+ docetaxel on overall survival (OS) of bidotaxel. To evaluate the benefit of SI-B001+ Docetaxel over Docetaxel's progression-free survival (PFS) based assessment. Secondary objectives: To evaluate the investigator-evaluated progression-free survival (PFS) benefit of SI-B001+ Docetaxel against docetaxel; To evaluate the difference of objective response rate (ORR), disease control rate (DCR) and duration of response (DOR) between SI-B001+ docetaxel and bidocetaxel. To evaluate the type, frequency and severity of adverse events (TEAE) and drug-related adverse events (TRAE) during treatment with SI-B001+ docetaxel in comparison with docetaxel. The pharmacokinetic (PK) characteristics of SI-B001 will be evaluated. The immunogenicity of SI-B001 will be evaluated. Subject quality of life.

Being tested
SI-B001, Docetaxel

What participants receive

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

  • SI-B001Drug

    Administration by intravenous infusion

  • DocetaxelDrug

    Administration by intravenous infusion

Study groups in NCT05943795
Study groupRoleWhat they receive
Experimental groupExperimentalParticipants receive SI-B001 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Receives: Drug: SI-B001
Control groupExperimentalParticipants receive Docetaxel as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Receives: Drug: Docetaxel

What is being measured

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

  1. Overall survival (OS)

    Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.

    Measured: Up to approximately 24 months

  2. Progression-free survival (PFS)

    Progression-free survival (PFS) as assessed by BIRC was defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.

    Measured: Up to approximately 24 months

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

    Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).

    Measured: Up to approximately 24 months

  2. Disease Control Rate (DCR)

    Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.

    Measured: Up to approximately 24 months

  3. Duration of Response (DOR)

    Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.

    Measured: Up to approximately 24 months

  4. Treatment Emergent Adverse Event (TEAE)

    TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of SI-B001. The type, frequency and severity of TEAE will be evaluated during the treatment of SI-B001.

    Measured: Up to approximately 24 months

  5. Anti-drug antibody (ADA)

    Characteristics of ADA will be evaluated.

    Measured: Up to approximately 24 months

Timeline

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

  1. First posted13 Jul 2023
  2. Study start14 Jul 2023
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2026 (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
None (open label)
Enrolment
589 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05943795
Sponsor's protocol ID
SI-B001-301
Status last verified
Jun 2025
First submitted
4 Apr 2023
Last updated
29 Jun 2025
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 SI-B001 and Docetaxel in people with Non-small Cell Lung Adenocarcinoma and Squamous Cell Carcinoma of Lung, run by Sichuan Baili Pharmaceutical Co., Ltd. at 2 sites 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 14 inclusion and 26 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 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 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?

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?

Overall survival (OS) (time frame: Up to approximately 24 months). The study lists 2 primary outcomes in all. 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 NCT05943795.

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 29 Jun 2025.

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