A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations
ConditionNSCLC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Center, China
About this trial
BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4 (CDK4) and CDK6 kinase activity. This open-label investigator-initiated trial (IIT) phase I study was designed to evaluate the safety and efficacy of oral BPI-1178 in combination with osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) Mutations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed written informed consent and ability to comply with the scheduled visits and study procedures outlined in the protocol.
Age ≥ 18 years, any gender.
Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (mainly adenocarcinoma) not suitable for curative surgery or radiation therapy.
ECOG Performance Status (ECOG PS) score of 0-1. Expected survival of at least 12 weeks.
Disqualifiers
History of prior or current use of anti-tumor drugs targeting CDK4/6.
Individuals with allergies or a history of severe allergic reactions.
Tissue, plasma, or cytological samples collected after radiological confirmation of disease progression, with testing confirming the presence of specific therapeutic targets such as anaplastic lymphoma kinase (ALK), BRAF V600E, or retinoblastoma (Rb) protein loss.
Received the last dose of anti-tumor treatment (chemotherapy, targeted therapy, investigational drugs, immunotherapy, tumor embolization, herbal medicine for anti-tumor purposes, etc.) within the 2 weeks preceding the start of study drug administration.
Trial design
Design model
Single group
Treatments tested in this trial
BPI-1178
Drug200 or 300 mg, oral, QD
Osimertinib
Drug80mg, oral, QD
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: BPI-1178 plus Osimertinib treatmentExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of patients with dose-limiting toxicity (DLT)
DLT will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).
Time frame
From first dosing (Day 7) to Day 28 of Cycle 1 (28 days/cycle)Secondary outcomes
1
Objective Response Rate (ORR)
The ORR is defined as the proportion of subjects with the best overall response of complete response (CR) or partial response (PR).
Time frame
Up to approximately 15 months2
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects with the best overall response of complete response (CR), partial response (PR), or stable disease (SD).
Time frame
Up to approximately 15 months3
Duration of Response (DoR)
In subjects with the best overall response of complete response (CR) or partial response (PR), it refers to the time from the initial occurrence of complete or partial response to the occurrence of disease progression or death for any reason (whichever comes first).
Time frame
Up to approximately 15 months4
Progression-Free Survival (PFS)
PFS is defined as the duration from the first study treatment until the onset of disease progression or death from any cause for the subjects.
Time frame
Up to approximately 15 monthsSponsors and contacts
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Source ClinicalTrials.gov