Non Small Cell Lung CancerPhase 2NCT05020457
SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC.
A Phase 2 study testing SI-B001, AP or TP and Docetaxel in people with Non Small Cell Lung Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 6 sites in China.
Trial summary
This multi-center, open label phase II clinical study is performed in patients with locally advanced or metastatic EGFR wild-type ALK wild-type non-small cell lung cancer progressed on prior anti-PD-1 mab ± platinum-based chemotherapy. 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, AP or TP and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 6 sitesChina
- Study dates
- 7 Dec 2021to Dec 2025
- Phase
- Phase 2
- 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 informed consent forms and follow program requirements；
- Male or female;
- Age: ≥ 18 years;
- Expected survival time ≥ 3 months;
- Patients with locally advanced or metastatic EGFR wild-type ALK wild-type lung cancer, disease progression or intolerance after first-line treatment with anti-PD-1/PD-L1 antibody, disease progression or intolerance after first-line treatment with anti-PD-1/PD-L1 antibody and platinum-based chemotherapy, or progression or intolerance after first-line treatment with anti-PD-1/PD-L1 monoclonal antibody;
- The subject agrees to provide archival tumor tissue samples or fresh tissue samples of the primary tumor or metastases within 6 months; if the subject is unable to provide tumor tissue samples and the subject is unable to provide the gene sequencing report, the subject shall agree to complete the ctDNA EGFR detection during the screening period, and can be assessed by the investigator if other inclusion criteria are met;
Show all 17Show fewer
- Must have at least one measurable lesion as defined by RECISTv1.1;
- Performance status score ECOG0 or 1;
- Toxicities from prior anticancer therapy have recovered to grade ≤ 2 as defined by NCI-CTCAEv5.0 (except alopecia);
- 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 × 109/L, platelet count ≥ 80 × 109/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
- Patients with past use of docetaxel；
- Prior to signing the informed consent, the gene sequencing or ctDNA testing report of the previous tissue samples indicated the presence of MET 14 exon jump positive, ROS1 rearrangement positive, BRAF V600E mutation positive, NTRK fusion positive, RET rearrangement positive, HER2 mutation positive, HER2 amplification positive, Patients with KRAS G12C mutation positive；
- Chemotherapy, biotherapy, immunotherapy, radical radiotherapy, and major surgery were used within 4 weeks before the first administration; palliative radiotherapy, targeted therapy (including small-molecule tyrosine kinase inhibitors) and other antitumor therapy were used within 2 weeks;
- Screening the history of severe heart disease within the first six months, such as: symptomatic congestive heart failure (CHF) ≥2 (CTCAE v5.0) history, New York Heart Society (NYHA) ≥2 heart failure, acute coronary syndrome, etc.;
- Prolonged QT interval (QTc > 450 msec in men or 470 msec in women), complete left bundle branch block, and Degree III atrioventricular block;
- Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, except for type I diabetes, hypothyroidism controllable by replacement therapy only, skin diseases not requiring systemic treatment (such as vitiligo, psoriasis);
Show all 17Show fewer
- Other malignancies diagnosed within 5 years prior to first dose,Exceptions include: radical basal cell carcinoma of the skin, scaly cell carcinoma of the skin, and/or radical resection of carcinoma in situ;
- Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg);
- Pulmonary disease defined as ≥ grade 3 according to CTCAEv5.0, including resting dyspnea, or requiring continuous oxygen therapy, or patients with a history of interstitial lung disease (ILD);
- Symptoms of active central nervous system metastases.However, patients with stable parenchymal metastases can be stable, and whether it is stable or not is judged by the investigator;
- Patients with a history of hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies or hypersensitivity to SI-B001 or any of the excipient components of Osimertinib;
- History of autologous or allogeneic stem cell transplantation;
- In previous anthracycline (neo) adjuvant therapy, the cumulative dose of anthracycline was > 360 mg/m2;
- Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number > 104) or hepatitis C virus (HCV) infection;
- Active infection requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;
- Received other unmarketed clinical study drugs or treatments within 4 weeks prior to study participation;
- Other conditions for trial participation were not considered by the investigator to be appropriate.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality
Sun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guangdong, 510075
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi
Shandong Cancer Hospital
Jinan, Shandong
TaiZhou Hospital of Zhejiang Province
Taizhou, Zhejiang
About this study
Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in Combination With Chemotherapy in the Treatment of EGFR WT and ALK WT Recurrent and Metastatic Non-small Cell Lung Cancer
This multi-center, open label phase II clinical study is performed in patients with locally advanced or metastatic EGFR wild-type ALK wild-type non-small cell lung cancer progressed on prior anti-PD-1 mab ± platinum-based chemotherapy. This study is investigating the safety and efficacy of SI-B001 at optimal combination dose with chemotherapy in patients.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- SI-B001, AP or TP, Docetaxel
- 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), if SI-B001 and chemotherapy are used on the same day, the infusion of chemotherapeutic drugs should be continued after the completion of SI-B001 infusion.
AP or TPDrug
Also called AP chemotherapy regimen was pemetrexed combined with cisplatin, and TP chemotherapy regimen was paclitaxel combined with cisplatin.
AP or TP should be administered immediately after SI-B001 is completed. The administration of AP or TP should refer to the drug instructions and standard usage.
DocetaxelDrug
Docetaxel should be administered immediately after SI-B001 is completed. The administration of Docetaxel should refer to the drug instructions and standard usage.
| Study group | Role | What they receive |
|---|---|---|
| SI-B001 combined with AP or TP_A | Experimental | SI-B001 combined with Platinum-based chemotherapy(AP or TP). Patients enrolled with EGFRwt/ALKwt NSCLC progressed or were intolerant after first-line treatment with anti-PD-1 /L1 mab alone. Receives: Drug: SI-B001; Drug: AP or TP |
| SI-B001 combined with Docetaxel_B | Experimental | Patients with EGFRwt/ALKwt non-small cell lung cancer were included and progressed or were intolerant after first-line treatment with platinum-based two-drug chemotherapy plus anti-PD-1 /L1 mab. Receives: Drug: SI-B001; Drug: Docetaxel |
| SI-B001 combined with Docetaxel_C | Experimental | Patients enrolled with EGFRwt/ALKwt NSCLC progressed or were intolerant to treatment with anti-PD-1 /PD-L1 monoclonal antibody after first-line or above chemotherapy. Receives: Drug: SI-B001; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate
Measured: Up to approximately 24 months
Optimal combination dose (only IIa)
Optimal combination dose of SI-B001 with chemotherapy (only IIa)
Measured: Up to approximately 24 months
Secondary outcomes (9)
OS
Overall Survival
Measured: Up to approximately 24 months
PFS
Progression Free Survival
Measured: Up to approximately 24 months
DCR
Disease Control Rate
Measured: Up to approximately 24 months
DOR
Duration of Response
Measured: Up to approximately 24 months
TEAE
Treatment Emergent Adverse Events
Measured: Up to approximately 24 months
Cmax
Maximum serum concentration
Measured: Up to approximately 24 months
Tmax
Time to maximum serum concentration
Measured: Up to approximately 24 months
Ctrough
Minimum serum concentration
Measured: Up to approximately 24 months
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.
- First posted25 Aug 2021
- Study start7 Dec 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (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.
- More trials run by Sichuan Baili Pharmaceutical 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Zhang, Principal investigator, Sun Yat-sen University Cancer Center (SYSUCC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020457
- Sponsor's protocol ID
- SI-B001_201
- 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in Combination With Chemotherapy in the Treatment of EGFR WT and ALK WT Recurrent and Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05020457
- Acronym / sponsor ID
- SI-B001_201
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Aug 2021 (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 multi-center, open label phase II clinical study is performed in patients with locally advanced or metastatic EGFR wild-type ALK wild-type non-small cell lung cancer progressed on prior anti-PD-1 mab ± platinum-based chemotherapy. This study is investigating the safety and efficacy of SI-B001 at optimal combination dose with chemotherapy in patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SI-B001 combined with AP or TP_A | Experimental | Drug: SI-B001, Drug: AP or TPSI-B001 combined with Platinum-based chemotherapy(AP or TP). Patients enrolled with EGFRwt/ALKwt NSCLC progressed or were intolerant after first-line treatment with anti-PD-1 /L1 mab alone. |
| SI-B001 combined with Docetaxel_B | Experimental | Drug: SI-B001, Drug: DocetaxelPatients with EGFRwt/ALKwt non-small cell lung cancer were included and progressed or were intolerant after first-line treatment with platinum-based two-drug chemotherapy plus anti-PD-1 /L1 mab. |
| SI-B001 combined with Docetaxel_C | Experimental | Drug: SI-B001, Drug: DocetaxelPatients enrolled with EGFRwt/ALKwt NSCLC progressed or were intolerant to treatment with anti-PD-1 /PD-L1 monoclonal antibody after first-line or above chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Voluntarily sign informed consent forms and follow program requirements；
- Male or female;
- Age: ≥ 18 years;
- Expected survival time ≥ 3 months;
- Patients with locally advanced or metastatic EGFR wild-type ALK wild-type lung cancer, disease progression or intolerance after first-line treatment with anti-PD-1/PD-L1 antibody, disease progression or intolerance after first-line treatment with anti-PD-1/PD-L1 antibody and platinum-based chemotherapy, or progression or intolerance after first-line treatment with anti-PD-1/PD-L1 monoclonal antibody;
Key exclusion criteria (17 listed)
- Patients with past use of docetaxel；
- Prior to signing the informed consent, the gene sequencing or ctDNA testing report of the previous tissue samples indicated the presence of MET 14 exon jump positive, ROS1 rearrangement positive, BRAF V600E mutation positive, NTRK fusion positive, RET rearrangement positive, HER2 mutation positive, HER2 amplification positive, Patients with KRAS G12C mutation positive；
- Chemotherapy, biotherapy, immunotherapy, radical radiotherapy, and major surgery were used within 4 weeks before the first administration; palliative radiotherapy, targeted therapy (including small-molecule tyrosine kinase inhibitors) and other antitumor therapy were used within 2 weeks;
- Screening the history of severe heart disease within the first six months, such as: symptomatic congestive heart failure (CHF) ≥2 (CTCAE v5.0) history, New York Heart Society (NYHA) ≥2 heart failure, acute coronary syndrome, etc.;
- Prolonged QT interval (QTc > 450 msec in men or 470 msec in women), complete left bundle branch block, and Degree III atrioventricular block;
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 |
|---|---|---|
| SI-B001SI-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), if SI-B001 and chemotherapy are used on the same day, the infusion of chemotherapeutic drugs should be continued after the completion of SI-B001 infusion. | Drug | SI-B001 combined with AP or TP_A, SI-B001 combined with Docetaxel_B, SI-B001 combined with Docetaxel_C |
| AP or TPAlso: AP chemotherapy regimen was pemetrexed combined with cisplatin, and TP chemotherapy regimen was paclitaxel combined with cisplatin.AP or TP should be administered immediately after SI-B001 is completed. The administration of AP or TP should refer to the drug instructions and standard usage. | Drug | SI-B001 combined with AP or TP_A |
| DocetaxelDocetaxel should be administered immediately after SI-B001 is completed. The administration of Docetaxel should refer to the drug instructions and standard usage. | Drug | SI-B001 combined with Docetaxel_B, SI-B001 combined with Docetaxel_C |
Primary outcome
ORR
Time frame: Up to approximately 24 months
Objective Response Rate
Optimal combination dose (only IIa)
Time frame: Up to approximately 24 months
Optimal combination dose of SI-B001 with chemotherapy (only IIa)
9 secondary outcomes
OS
Time frame: Up to approximately 24 months
PFS
Time frame: Up to approximately 24 months
DCR
Time frame: Up to approximately 24 months
DOR
Time frame: Up to approximately 24 months
TEAE
Time frame: Up to approximately 24 months
Cmax
Time frame: Up to approximately 24 months
Tmax
Time frame: Up to approximately 24 months
Ctrough
Time frame: Up to approximately 24 months
ADA
Time frame: Up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
Related trials for Non Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Li Zhang principal investigator
Sun Yat-sen University Cancer Center (SYSUCC)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SI-B001, AP or TP and Docetaxel in people with Non Small Cell Lung Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 6 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 6 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 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?
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?
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.