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Non-small Cell Lung CancerPhase 2/3NCT05020769

SI-B001 Combined With Osimertinib Mesylate Tablets in the Treatment of Recurrent Metastatic Non-small Cell Lung Cancer.

A Phase 2/3 study testing SI-B001 and Osimertinib in people with Non-small Cell Lung Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 3 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

This multi-center, open label Phase II/III clinical study is performed in patients with locally advanced/metastatic NSCLC progressed on prior EGFR-TKI treatment or with non TKI-sensitizing mutation or patients with EGFR exon20ins mutation. 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?
SI-B001 and Osimertinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
3 sitesChina
Study dates
6 Jan 2022to Dec 2025
Phase
Phase 2/3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily sign the informed consent and follow the requirements of the protocol;
  • Male or female;
  • Age: ≥ 18 years;
  • Expected survival time ≥ 3 months;
  • Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed by histopathology and/or cytology, T790M-negative, Exon20ins mutation resistant to the third generation EGFR TKI after the first or second line treatment, or resistance to the first or second generation TKI after the first line treatment;
  • Consent to provide an archived tumor tissue specimen or fresh tissue sample (an FFPE block or approximately 6-12 white slides with a size of 5μm) from the primary or metastatic tumor within 6 months of the date of consent. Participants who were unable to provide tumor tissue samples could be enrolled if they met other inclusion and exclusion criteria after evaluation by investigators.
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  • Must have at least one measurable lesion as defined by RECISTv1.1;
  • Performance status score ECOG0 or 1;
  • Toxicity from previous antineochemical therapy has returned to grade 1 or less as defined by NCI-CTCAE v5.0 (asymptomatic laboratory abnormalities such as elevated ALP, hyperuricemia, elevated serum amylase/lipase, and elevated blood glucose were considered by the investigator, and toxicity with no safety risk was judged by the investigator; Except for alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism stable with hormone replacement therapy).
  • No severe cardiac dysfunction, left ventricular score ≥ 50%;
  • The level of organ function must meet the following criteria:
  • Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet count ≥ 80 × 10^9/L, hemoglobin ≥ 90 g/L;
  • Liver function: TBIL ≤ 1.5ULN (total bilirubin ≤ 3ULN for subjects with Gilbert's syndrome, liver cancer or liver metastases); AST and ALT ≤ 2.5ULN for subjects without liver metastases; AST and ALT ≤ 5.0ULN for subjects with liver metastases;
  • Renal function: creatinine (Cr) ≤ 1.5ULN, or creatinine clearance (Ccr) ≥ 50 mL/min (according to CockcroftandGault formula).
  • Coagulation function: international normalized ratio (INR) ≤ 1.5 × ULN, and activated partial thromboplastin time (APTT) ≤ 1.5ULN;
  • Urine protein ≤ 2 + (measured by dipstick) or < 1000 mg/24 h (urine);
  • Premenopausal women of childbearing potential must have a negative serum or urine pregnancy test 7 before starting treatment and must be non-lactating; all patients (male or female) should take adequate barrier contraception measures throughout the treatment cycle and 6 months after the end of treatment.

Who cannot join

  • Gene sequencing showed that there were MET, ALK, RET, HER2 and other driver gene mutations related to the occurrence and development of tumors.
  • Patients with prior systemic chemotherapy as part of first - or second-line systemic therapy;
  • Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, and major surgery were used within 4 weeks before the first dose, and palliative radiotherapy, targeted therapy (including small molecule tyrosine kinase inhibitors), and other anti-tumor treatments were used within 2 weeks before the first dose.
  • The history of severe heart disease within the past six months was screened, such as symptomatic congestive heart failure (CHF) ≥ grade 2 (CTCAE v5.0), New York Heart Association (NYHA) ≥ grade 2 heart failure, acute coronary syndrome, etc.
  • Prolonged QT interval (QTc > 450 msec in men or QTc > 470 msec in women), complete left bundle branch block, atrioventricular block III degree;
  • Active autoimmune and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory intestinal diseases and Hashimoto's thyroiditis, etc., excluding type I diabetes mellitus, hypothyroidism that can be controlled only by replacement therapy, and skin diseases without systemic treatment (such as vitiligo and psoriasis);
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  • Other malignant tumors diagnosed within 5 years before the first dose of treatment, except those with radical basal cell carcinoma, squamous cell carcinoma of the skin, and/or radical resection in situ carcinoma considered by investigators to be eligible;
  • Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg);
  • Pulmonary disease grade ≥3 was defined according to CTCAE v5.0, including dyspnea at rest, or requiring continuous oxygen therapy, or a history of interstitial lung disease (ILD).
  • There were symptoms of active central nervous system metastasis. However, patients with stable parenchymal metastases could be enrolled, and whether they were stable was defined by the investigators.
  • 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 chemotherapeutic agents used in this trial;
  • A history of autologous or allogeneic stem cell transplantation;
  • The cumulative dose of anthracyclines in previous (new) adjuvant therapy was > 360 mg/m^2;
  • Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number > 10^4) or hepatitis C virus infection (HCV-RNA > the lower limit of detection in the research center);
  • Active infections requiring systemic therapy, such as severe pneumonia, bacteremia, sepsis, etc.;
  • Received other unmarketed investigational drugs or treatments within 4 weeks before study enrollment;
  • Other conditions for trial participation were not considered by the investigator to be appropriate

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Sun Yat-sen University Cancer Center (SYSUCC)

    Guangdong, Guangzhou, 510075

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi

Other trials in China

About this study

Official title: A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in Combination With Osimertinib Mesylate Tablets in the Treatment of Recurrent and Metastatic Non- Small Cell Lung Cancer

This multi-center, open label Phase II/III clinical study is performed in patients with locally advanced/metastatic NSCLC progressed on prior EGFR-TKI treatment or with non TKI-sensitizing mutation or patients with EGFR exon20ins mutation. This study is investigating the safety and efficacy of SI-B001 at monotherapy RP2D or lower combined with Osimertinib in patients with locally advanced or metastatic NSCLC.

Being tested
SI-B001, Osimertinib
Keywords
NSCLC
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.

  • SI-B001Drug

    SI-B001 is administered by intravenous drip once weekly (QW). 120 min ± 10 min after the first intravenous drip, if the infusion reaction is tolerable during the first dose, the subsequent infusion can be completed within 60-120 min (unless agreed or required by the investigator, the infusion time can be extended).

  • OsimertinibDrug

    Osimertinib is administered at the recommended dose of 80mg daily.

Study groups in NCT05020769
Study groupRoleWhat they receive
SI-B001 combined with osimertinib_AExperimentalPatients with locally advanced/metastatic NSCLC progressed on 3rd generation EGFR-TKI treatment.
Receives: Drug: SI-B001; Drug: Osimertinib
SI-B001 combined with osimertinib_BExperimentalPatients with locally advanced/metastatic NSCLC progressed on prior EGFR-TKI treatment and with T790M negative mutation.
Receives: Drug: SI-B001; Drug: Osimertinib
SI-B001 combined with osimertinib_CExperimentalPatients with locally advanced/metastatic NSCLC and with EGFR exon20ins mutation.
Receives: Drug: SI-B001; Drug: Osimertinib

What is being measured

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

  1. ORR

    Objective Response Rate

    Measured: Up to approximately 24 months

  2. Optimal combination dose (only Phase IIa)

    Optimal combination dose for SI-B001 and Osimertinib (only IIa)

    Measured: Up to approximately 24 months

Secondary outcomes (8)

  1. PFS

    Progression-free Survival

    Measured: Up to approximately 24 months

  2. DCR

    Disease Control Rate

    Measured: Up to approximately 24 months

  3. DOR

    Duration of Response

    Measured: Up to approximately 24 months

  4. TEAE

    Treatment Emergent Adverse Events

    Measured: Up to approximately 24 months

  5. Cmax

    Maximum serum concentration

    Measured: Up to approximately 24 months

  6. Tmax

    Time to maximum serum concentration

    Measured: Up to approximately 24 months

  7. Ctrough

    Minimum serum concentration

    Measured: Up to approximately 24 months

  8. ADA

    anti-SI-B001 antibody

    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 posted25 Aug 2021
  2. Study start6 Jan 2022
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (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 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05020769
Sponsor's protocol ID
SI-B001_210
Status last verified
Sep 2025
First submitted
22 Aug 2021
Last updated
26 Sep 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 2/3 study testing SI-B001 and Osimertinib in people with Non-small Cell Lung Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 3 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 17 inclusion and 17 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 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 combined 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.

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?

ORR (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 NCT05020769.

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 26 Sep 2025.

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