Health TrialsbyHealthPanel

IN10018 Combination Therapy in Advanced EGFR Mutation-positive NSCLC

ConditionNSCLC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInxMed (Shanghai) Co., Ltd.

About this trial

This is a multicenter, open-label, phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics and antitumor efficacy of IN10018 in combination with third-generation EGFR-TKI (Furmonertinib is the proposed) in previously-treated or naïve advanced EGFR-mutation positive NSCLC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be able to understand and be willing to sign informed consent.

Male or female aged ≥ 18 years old at the time of signing informed consent.

Histologically or cytologically confirmed locally advanced or metastatic NSCLC, who is not suitable for radical surgery or radiotherapy.

Documented EGFR mutations known to be associated with EGFR-TKI sensitivity, including Ex19del or L858R. Except for EGFR-TKI sensitive mutation, coexisting with other EGFR mutation types such as T790M can be allowed.

Disqualifiers

Have experienced major surgical procedures or major trauma within 28 days prior to the first dose of study treatment/randomization.

Cohort 1: Have received chemotherapy, target therapy besides Furmonertinib, immunotherapy, biological therapy, and other antitumor drugs.

Cohort 2: Have received chemotherapy, targeted therapy, immunotherapy, biological therapy, and other antitumor drugs within 28 days prior to the first dose of study treatment.

Cohort 3: Have received systemic antitumor therapy for locally-advanced or metastatic NSCLC including chemotherapy, target therapy, immunotherapy, biotherapy, etc.

Trial design

Design model

Parallel

Treatments tested in this trial

  • IN10018

    Drug

    orally taken once daily

  • Furmonertinib

    Drug

    orally taken once daily

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Experimental Group in cohort 1, cohort 2, and cohort 3Experimental treatment 2 interventions
Group B: Control Group in cohort 3Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recommended phase II dose (RP2D) of IN10018 in combination with third-generation EGFR-TKI in subjects with advanced EGFR mutation-positive NSCLC.

Evaluate the number of patients with dose-limited toxicities (DLTs); Determine the RP2D of IN10018 in combination with third-generation EGFR-TKI in subjects with advanced NSCLC.

Time frame
3 years
2

ORR of IN10018 in combination with third-generation EGFR-TKI in subjects with advanced EGFR mutation-positive NSCLC.

Defined as the proportion of subjects with complete response (CR) or partial response (PR)

Time frame
3 years
3

Tumor Shrinkage Rate (TSR) of IN10018 in combination with third-generation EGFR-TKI in cohort 3 of advanced treatment-naive EGFR mutation-positive NSCLC.

Defined as the percentage of subjects with the best shrinkage rate of target lesions ≥ 70% and simultaneously with a best response of partial response (PR) or complete response (CR).

Time frame
3 years

Secondary outcomes

1

PFS of IN10018 in combination with third-generation EGFR-TKI in advanced EGFR mutation-positive NSCLC.

Defined as the time from the first dose of study treatment/randomization to first documentation of disease progression or to death due to any cause, whichever comes first.

Time frame
3 years
2

DOR of IN10018 in combination with third-generation EGFR-TKI in advanced EGFR mutation-positive NSCLC.

Defined as the time from start of the first documentation of CR or PR to the first documentation of disease progression or to death due to any cause, whichever comes first.

Time frame
3 years
3

DCR of IN10018 in combination with third-generation EGFR-TKI in advanced EGFR mutation-positive NSCLC.

Defined as the proportion of patients with CR, PR, or stable disease (SD).

Time frame
3 years
4

OS of IN10018 in combination with third-generation EGFR-TKI in advanced EGFR mutation-positive NSCLC.

Defined as the time from the first dose of study treatment/randomization to the date of death due to any cause.

Time frame
3 years

Other outcomes

Sponsors and contacts

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

InxMed (Shanghai) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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