A Phase Ⅱ Study of RC108 in Combination With Furmonertinib for the First-line Treatment of EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRemeGen Co., Ltd.

About this trial

Evaluate the efficacy and safety of RC108 in combination with Furmonertinib against Furmonertinib for treatment of EGFR mutation combined with MET-positive unresectable locally advanced or recurrent metastatic NSCLC

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate in the study and signed the ICF;

Male or female, aged 18-75 years;

All participants to be enrolled must be diagnosed with histopathologically or cytologically confirmed, unresectable locally advanced (stage IIIB/IIIC )or recurrent metastatic NSCLC (stage IV ) and not amendable to curative surgery or radiation as assessed by investigator;

For previously locally advanced or recurrent metastatic disease not treated with systemic antitumor therapy;

Disqualifiers

Subjects with the presence of meningeal metastases, spinal cord compression, or active brain metastases;

Received ADC or MET inhibitors;

Suffering from refractory nausea and vomiting, chronic gastrointestinal disorders, inability to swallow pharmaceutical preparations, or previous major bowel resection that may prevent adequate absorption, distribution, metabolism, or excretion of oral medications;

Subjects with uncontrolled tumor-related pain;

Trial design

Design model

Parallel

Treatments tested in this trial

  • RC108

    Drug

    RC108 in Combination With Furmonertinib

  • Furmonertinib Mesilate Tablets Monotherapy

    Drug

    Furmonertinib

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 2 interventions
Group B: Arm 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

Investigator-assessed ORR

Time frame
24 months

Secondary outcomes

1

Progression-free survival (PFS)

Investigator-assessed PFS

Time frame
24 months
2

Disease Control Rate (DCR)

Investigator-assessed DCR

Time frame
24 months
3

Duration of Response (DoR)

Investigator-assessed DoR

Time frame
24 months
4

Overall survival (OS)

Investigator-assessed OS

Time frame
45 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.