CClinicalTrials.gg
Sign In
RecruitingNCT05994131Updated Apr 30, 2025

IN10018 Combination Therapy in Advanced EGFR Mutation-positive NSCLC

A Phase 1/2 interventional study of IN10018 and Furmonertinib in NSCLC, sponsored by InxMed (Shanghai) Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-30.

Sponsored by InxMed (Shanghai) Co., Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 2 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This study includes 2 parts: Phase Ib-Dose Confirmation and Phase II-Dose Expansion. And 3 cohorts are set up in this study as cohort 1 to enroll subjects currently accepting third-generation EGFR-TKI (Furmonertinib is proposed) as first-line treatment, cohort 2 to enroll subjects who previously accepted third-generation EGFR-TKI treatment and 1-2 lines chemotherapy, and cohort 3 to enroll treatment-naive advanced EGFR mutation-positive NSCLC subjects.

The phase Ib-dose confirmation part will be conducted in cohort 2 and aim to determine the recommended phase II dose (RP2D) of IN10018 in combination with Furmonertinib. Phase II-Dose Expansion part will be conducted in cohort 1-3 and further explore the antitumor efficacy, safety and PK of IN10018 in combination with Furmonertinib in subjects with previously-treated or naïve advanced EGFR mutation-positive NSCLC.

02

Conditions studied

  • NSCLC

Keywords

  • EGFR mutation-positve
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 110 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

InxMed (Shanghai) Co., Ltd. is the lead sponsor of 13 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Be able to understand and be willing to sign informed consent.
  2. Male or female aged ≥ 18 years old at the time of signing informed consent.
  3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC, who is not suitable for radical surgery or radiotherapy.
  4. 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.

  5. Prior systemic antitumor therapy allowed are listed as follows:

    • Cohort 1: Subjects who are on the treatment of Furmonertinib as the first-line treatment setting.
    • Cohort 2: Subjects failed in third-generation EGFR-TKI treatment and also failed in or were intolerant to 1-2 lines of chemotherapy.
    • Cohort 3: subjects who haven't accepted any systemic therapy before. Prior adjuvant or neoadjuvant chemotherapy is permitted if an interval from the lost dose of adjuvant or neoadjuvant chemotherapy to the first documented PD is >6 months.
  6. Measurable lesions at baseline according to RECIST 1.1 criteria.
  7. Has an ECOG performance status of 0 or 1.
  8. Estimated life expectancy is more than 3 months.
  9. Adequate bone marrow, liver, renal, and coagulation function within 7 days prior to the first dose of study treatment/randomization.

Exclusion criteria

Exclusion Criteria

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

  2. Have received the following prior systemic antitumor therapy:

    • 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.
  3. 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.
  4. Cohort 3 only：Has received the treatment of EGFR-TKI。
  5. Prior FAK inhibitors treatment.
  6. 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.
  7. 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.
  8. Has had interstitial lung disease (ILD), drug-induced ILD, radiation pneumonia requiring steroid therapy; or diagnosis of clinically active ILD during the screening period.
  9. Has a prior history of other malignancy within 3 years prior to signing informed consent.
  10. Has known symptoms of spinal cord compression, active central nervous system (CNS) metastases, and/or carcinomatous meningitis.
  11. Has a history of severe cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment/randomization.
  12. Has known uncontrollable pleural effusion, pericardial effusion, and ascites.
  13. Has hemoptysis within 1 month prior to the first dose of study treatment/randomization with a blood volume of ≥2.5 mL every time or expected to require continuous hemostasis therapy during the study treatment.
  14. Has active infections that are poorly controlled by systemic treatment.
  15. Has active tuberculosis.
  16. Known allergy, hypersensitivity or intolerance to IN10018 and/or third-generation EGFR-TKI, or their ingredients.
  17. Pregnant or lactating women.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    Experimental Group in cohort 1, cohort 2, and cohort 3

    IN10018+Furmonertinib

    Drug: IN10018 · Drug: Furmonertinib

  • Active comparator
    Control Group in cohort 3

    Furmonertinib

    Drug: Furmonertinib

Interventions

  • DrugIN10018

    orally taken once daily

    Also known as: BI 853520

  • DrugFurmonertinib

    orally taken once daily

06

What researchers measure

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

  5. Number of patients with adverse event

    The number of participants who experienced AEs is presented.

    Time frame: 3 years

  6. PK: AUC of IN10018 following single dose administration and at steady state

    Area under the concentration-time curve (AUC)

    Time frame: 3 years

  7. PK: Cmax of IN10018 following single dose administration and at steady state

    Maximum concentration (Cmax)

    Time frame: 3 years

  8. PK:Ctrough of IN10018 following single dose administration and at steady state

    Trough concentration (Ctrough)

    Time frame: 3 years

  9. PK:Tmax of IN10018 following single dose administration and at steady state

    Time to Cmax (Tmax)

    Time frame: 3 years

  10. PK:t1/2 of IN10018 following single dose administration and at steady state

    Elimination half-life (t1/2).

    Time frame: 3 years

  11. PK:CL/F of IN10018 following single dose administration and at steady state

    apparent clearance (CL/F)

    Time frame: 3 years

  12. PK:Vd/F of IN10018 following single dose administration and at steady state

    Apparent volume of distribution (Vd/F)

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Shanghai Pulmonary Hospital
    Shanghai, China
    • Caicun Zhou · Contact · caicunzhoudr@163.com · +86 13301825532
    • Caicun Zhou · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05994131
Lead sponsor
InxMed (Shanghai) Co., Ltd.
Responsible party
Sponsor
First posted
Aug 16, 2023
Start date
Jul 13, 2023
Primary completion
Jul 31, 2026 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
Apr 30, 2025

Study contacts

Bohong Zhang
Contact
bohong.zhang@inxmed.com
+86 18801955197
Caicun Zhou
principal investigator · Shanghai Pulmonary Hospital, Shanghai, China

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Carcinoma, Non-Small-Cell Lung→

Other studies from this sponsor

InxMed (Shanghai) Co., Ltd.

Start the discussion