IN10018 Combination Therapy in Advanced EGFR Mutation-positive NSCLC
China110 participantsStarted 2023-07-13
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Prior systemic antitumor therapy allowed are listed as follows:
✓. Measurable lesions at baseline according to RECIST 1.1 criteria.
✓. Has an ECOG performance status of 0 or 1.
✓. Estimated life expectancy is more than 3 months.
Exclusion criteria
✕. Have experienced major surgical procedures or major trauma within 28 days prior to the first dose of study treatment/randomization.
✕. Have received the following prior systemic antitumor therapy:
✕. Cohort 2 only： Presence of other gene mutations, including ALK mutation, MET amplification, HER2 amplification, RAS mutation, etc. after progression on prior third-generation EGFR-TKI treatment.
✕
What they're measuring
1
Recommended phase II dose (RP2D) of IN10018 in combination with third-generation EGFR-TKI in subjects with advanced EGFR mutation-positive NSCLC.
Timeframe: 3 years
2
ORR of IN10018 in combination with third-generation EGFR-TKI in subjects with advanced EGFR mutation-positive NSCLC.
Timeframe: 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.
. Cohort 3 only：Has received the treatment of EGFR-TKI。
✕. Prior FAK inhibitors treatment.
✕. Have received systemic administration of potent inhibitors/inducers of CYP3A4, or P-gp inhibitors within 14 days prior to the first dose of treatment/randomization or are expected to receive systemic administration of these drugs during study treatment.
✕. Has received radiotherapy for study disease or radiotherapeutic area covered for more than 30% of the bone marrow within 28 days prior to the first dose of study treatment/randomization.
✕. Has had interstitial lung disease (ILD), drug-induced ILD, radiation pneumonia requiring steroid therapy; or diagnosis of clinically active ILD during the screening period.