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

NCT05020769 | Active Not Recruiting Phase 2

• 1 other identifier: SI-B001_210
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC

Outcome Measures

Primary Outcomes (2)

• ORR

  Objective Response Rate

  Up to approximately 24 months

• Optimal combination dose (only Phase IIa)

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

  Up to approximately 24 months

Secondary Outcomes (8)

• PFS

  Up to approximately 24 months

• DCR

  Up to approximately 24 months

• DOR

  Up to approximately 24 months

• TEAE

  Up to approximately 24 months

• Cmax

  Up to approximately 24 months

Study Arms (3)

SI-B001 combined with osimertinib_A

EXPERIMENTAL

Patients with locally advanced/metastatic NSCLC progressed on 3rd generation EGFR-TKI treatment.

Drug: SI-B001; Drug: Osimertinib

SI-B001 combined with osimertinib_B

EXPERIMENTAL

Patients with locally advanced/metastatic NSCLC progressed on prior EGFR-TKI treatment and with T790M negative mutation.

Drug: SI-B001; Drug: Osimertinib

SI-B001 combined with osimertinib_C

EXPERIMENTAL

Patients with locally advanced/metastatic NSCLC and with EGFR exon20ins mutation.

Drug: SI-B001; Drug: Osimertinib

Interventions

SI-B001 DRUG

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).

SI-B001 combined with osimertinib_A; SI-B001 combined with osimertinib_B; SI-B001 combined with osimertinib_C

Osimertinib DRUG

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

SI-B001 combined with osimertinib_A; SI-B001 combined with osimertinib_B; SI-B001 combined with osimertinib_C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead

Study Sites (3)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

The Second Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

Location

Sun Yat-sen University Cancer Center (SYSUCC)

Guangdong, Guangzhou, 510075, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Li Zhang

  Sun Yat-sen University Cancer Center (SYSUCC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: August 25, 2021
• Study Start: January 6, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

CN (3)