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

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT05020769
Phase
PHASE2/PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).
  • Osimertinib — DRUG
    Osimertinib is administered at the recommended dose of 80mg daily.

Study Details

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.

Key Dates

Start date
Jan 6, 2022
Status verified
Sep 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SI-B001 combined with osimertinib_A
    Patients with locally advanced/metastatic NSCLC progressed on 3rd generation EGFR-TKI treatment.
  • Experimental: SI-B001 combined with osimertinib_B
    Patients with locally advanced/metastatic NSCLC progressed on prior EGFR-TKI treatment and with T790M negative mutation.
  • Experimental: SI-B001 combined with osimertinib_C
    Patients with locally advanced/metastatic NSCLC and with EGFR exon20ins mutation.

Primary Outcome Measure

ORR [ Time Frame: Up to approximately 24 months ]

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