RC108 Combine With Furmonertinib With/Without Toripalimab in Patients With EGFR-mutated NSCLC
ConditionNSCLC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRemeGen Co., Ltd.
About this trial
an open, single-arm, multicenter phase Ib/II study
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily agree to participate in the study and sign an informed consent form.
Age between 18 and 75 years old (inclusive).
Expected survival period of at least 12 weeks as determined by the investigator.
ECOG performance status of 0 or 1.
Disqualifiers
Have used an investigational drug within 4 weeks prior to the start of study dosing.
Have undergone major surgery within 4 weeks prior to the start of study dosing and have not fully recovered.
Received a live vaccine within 4 weeks prior to the start of study dosing or are scheduled to receive any vaccine (except novel inactivated coronavirus vaccine) during the study period.
An arterial/venous thrombotic event such as a cardiovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism within 6 months prior to study dosing.
Trial design
Design model
Sequential
Treatments tested in this trial
RC108
DrugRC108 plus Furmonertinib and/or Toripalimab
Treatment groups
106 Participants
are divided into 4 treatment groupsGroup A: cohort 1 RC108 plus FurmonertinibExperimental treatment 1 intervention
Group B: cohort 2 RC108 plus Furmonertinib and ToripalimabExperimental treatment 1 intervention
Group C: cohort 3 RP2D RC108 plus FurmonertinibExperimental treatment 1 intervention
Group D: cohort 4 RP2D RC108 plus Furmonertinib and ToripalimabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
Time frame
up to 24 months2
Dose limiting toxicity (DLT)
To observe the durability and safety of RC108 plus Furmonertinib or plus Furmonertinib and Toripalimab in patients with advanced after single and multiple administration, observe the dose limiting toxicity (DLT)and the reversibility of toxicity
Time frame
21-daysSecondary outcomes
1
Progression Free Survival (PFS)
Tumor response was assessed by investigator according to RECIST v1.1
Time frame
up to 24 months2
Duration of Response (DOR)
DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier
Time frame
up to 24 months3
Disease control rate (DCR)
DCR was defined as the proportion of patients who achieved an objective response or maintained stable disease during the study
Time frame
up to 24 months4
Overall Survival(OS)
OS was defined as the time from the first study treatment to the date of death from any cause
Time frame
up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov