Small Cell Lung Cancer Extensive StagePhase 1/2NCT06030258
IN10018 Combination Therapy in Treatment-naïve ES-SCLC
A Phase 1/2 study testing IN10018, Tislelizumab and Carboplatin in people with Small Cell Lung Cancer Extensive Stage, run by InxMed (Shanghai) Co., Ltd. at 3 sites in China.
Trial summary
This is a multicenter, open-label, Randomized, phase Ib/II clinical study to evaluate the anti-tumor efficacy, safety, tolerability, and PK of IN10018 in combination with anti-PD-1/L1 monoclonal antibody (Tislelizumab is proposed as the combination drug) and chemotherapy (platinum and etoposide) as the first-line… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer Extensive Stage
- What is being tested?
- IN10018, Tislelizumab and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesChina
- Study dates
- 30 Oct 2023to 24 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18-75 years old at the time of signing informed consent.
- Be able to understand and be willing to sign informed consent.
- Histologically confirmed ES-SCLC (according to the Veterans Administration Lung Study Group (VALG) staging system), which is not suitable for locally radical therapy.
- Has not received any systemic antitumor therapy for ES-SCLC.
- Has at least one measurable tumor lesion per RECIST 1.1.
- Has an ECOG performance status of 0 or 1.
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- Estimated life expectancy is more than 3 months.
- Has adequate organ function of bone marrow, liver, kidney, and coagulation. Relative laboratory tests must be performed within 7 days prior to first dose of study treatment/randomization.
- AEs due to prior antitumor therapy must be recovered to ≤ Grade 1 (CTCAE v5.0) or a steady state as assessed by investigators
- Subjects (male and female) with childbearing potential must agree to use contraception during the treatment phase and through 3 months after the last dose of study treatment.
Who cannot join
- Has known active or untreated central nervous system (CNS) metastases, and/or carcinomatous meningitis.
- Spinal cord compression without surgery and/or radiation therapy, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for at least 7 days prior to the first dose of study treatment/randomization.
- Pleural, pericardial or abdominal effusion that are clinically symptomatic and require puncture or drainage.
- Symptomatic hypercalcemia.
- Malignancies other than the study disease within 3 years prior to the first dose of study treatment/randomization.
- Have received palliative radiotherapy for bone metastasis within 14 days prior to the first dose of study treatment/randomization.
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- Have had allogeneic haematopoietic stem cell transplantation or organ transplantation.
- History of active autoimmune disease required systemic treatment (including but not limited to drugs for disease control, corticosteroids, or immunosuppressive drugs) within the past 2 years.
- Have an immunodeficiency disorder or have received systemic steroid therapy (prednisone or equivalent corticosteroid > 10 mg/day) or other immunosuppressants within 7 days prior to the first dose of study treatment/randomization.
- History of idiopathic pulmonary fibrosis, idiopathic pneumonia and organizing pneumonia, and interstitial pneumonitis or active pneumonia diagnosed per imaging examination at baseline.
- Have had FAK inhibitors treatment.
- Has a history of major cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment/randomization.
- Have malabsorption syndrome or cannot take study drugs orally.
- Any active infection requiring systemic therapy within 14 days prior to the first dose of study treatment.
- Active pulmonary tuberculosis
- Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
- Known hypersensitivity or allergy to IN10018, anti-PD-1/L1 monoclonal antibodies, carboplatin or etoposide or to their drug components.
- Pregnant or lactating women or are expected to be pregnant or lactating during study treatment.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Shandong Province Cancer Hospital
Jinan
Yuping Sun
- Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Peng Chen
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou
Shundong Cang
About this study
Official title: A Phase Ib/II Clinical Trial to Evaluate the Anti-tumor Efficacy, Safety, Tolerability, and Pharmacokinetics of IN10018 Combined With Anti-PD-1/L1 Antibody and Chemotherapy as First-line Treatment in Extensive-stage Small Cell Lung Cancer
This is a multicenter, open-label, Randomized, phase Ib/II clinical study to evaluate the anti-tumor efficacy, safety, tolerability, and PK of IN10018 in combination with anti-PD-1/L1 monoclonal antibody (Tislelizumab is proposed as the combination drug) and chemotherapy (platinum and etoposide) as the first-line treatment in Extensive-stage small cell lung cancer (ES-SCLC).
Read the detailed description
This study consists of 2 parts: 1) Phase Ib-Dose Confirmation part: To assess the PK parameters, safety and recommended phase II dose (RP2D) of IN10018 in combination with anti-PD-1/L1 monoclonal antibody (Tislelizumab is proposed as the combination drug), platinum (carboplatin is proposed as the combination drug) and etoposide as the first-line treatment in ES-SCLC. 2) Phase II-Dose Expansion part: To assess the antitumor efficacy, safety and tolerability in the experimental group of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to the control group of Tislelizumab in combination with carboplatin and etoposide as the first-line treatment in ES-SCLC.
- Conditions
- Small Cell Lung Cancer Extensive Stage
- Being tested
- IN10018, Tislelizumab, Carboplatin, Etoposide
- Keywords
- First-line
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN10018Drug
Also called BI 853520
orally taken once daily
TislelizumabDrug
200mg D1, Q3W, intravenously
CarboplatinDrug
AUC 5 mg/ml/min, D1, Q3W, intravenously
EtoposideDrug
Etoposide 100 mg/m2, D1-D3, Q3W, intravenously
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | IN10018 in combination with Tislelizumab, carboplatin and etoposide as the first-line treatment in ES-SCLC. Receives: Drug: IN10018; Drug: Tislelizumab; Drug: Carboplatin; Drug: Etoposide |
| Control group | Active comparator | Tislelizumab in combination with carboplatin and etoposide as the first-line treatment in ES-SCLC Receives: Drug: Tislelizumab; Drug: Carboplatin; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the Recommended phase II dose (RP2D) of IN10018 in combination with Tislelizumab, Carboplatin and Etoposide in first-line ES-SCLC.
Evaluate proportion of patients suffered with AEs defined as dose-limited toxicities (DLTs) per protocol; and RP2D will be determined per the incidence of AEs defined as DLTs.
Measured: Up to 3 years
Progress free survival (PFS) of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC per BICR based on RECIST 1.1
Defined as the time from randomization to first documentation of disease progression or to death due to any cause, whichever comes first.
Measured: Up to 3 years
Secondary outcomes (13)
PFS of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC per investigator based on RECIST 1.1
Defined as the time from randomization to first documentation of disease progression or to death due to any cause, whichever comes first.
Measured: Up to 3 years
Objective response rate (ORR) of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC per BICR and investigator based on RECIST 1.1.
Defined as the proportion of subjects with complete response (CR) or partial response (PR).
Measured: Up to 3 years
Duration of objective response (DOR) of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC per BICR and investigator based on RECIST 1.1.
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.
Measured: Up to 3 years
Disease Control Rate (DCR) of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC per BICR and investigator based on RECIST 1.1
Defined as the proportion of patients with CR, PR, or stable disease (SD).
Measured: Up to 3 years
Overall survival (OS) of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC.
Defined as the time from randomization to the date of death due to any cause.
Measured: Up to 3 years
Number of patients with adverse event
The number of participants who experienced AEs is presented.
Measured: Up to 3 years
PK: AUC of IN10018 following single dose administration and at steady state
Area under the concentration-time curve (AUC)
Measured: Up to 3 years
PK: Cmax of IN10018 following single dose administration and at steady state
Maximum concentration (Cmax)
Measured: Up to 3 years
PK: Ctrough of IN10018 following single dose administration and at steady state
Trough concentration (Ctrough)
Measured: Up to 3 years
PK: Tmax of IN10018 following single dose administration and at steady state
Time to Cmax (Tmax)
Measured: Up to 3 years
PK: t1/2 of IN10018 following single dose administration and at steady state
Elimination half-life (t1/2)
Measured: Up to 3 years
PK: CL/F of IN10018 following single dose administration and at steady state
apparent clearance (CL/F)
Measured: Up to 3 years
PK: Vd/F of IN10018 following single dose administration and at steady state
Apparent volume of distribution (Vd/F)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start30 Oct 2023
- Primary completion24 Dec 2025 (estimated)
- Study completion24 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer Extensive StageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InxMed (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun Zhao, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030258
- Sponsor's protocol ID
- IN10018-019
- Status last verified
- Apr 2025
- First submitted
- 1 Sep 2023
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Trial to Evaluate the Anti-tumor Efficacy, Safety, Tolerability, and Pharmacokinetics of IN10018 Combined With Anti-PD-1/L1 Antibody and Chemotherapy as First-line Treatment in Extensive-stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06030258
- Acronym / sponsor ID
- IN10018-019
- Conditions
- Small Cell Lung Cancer Extensive Stage
- Keywords
- First-line
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- InxMed (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 24 Dec 2025 (estimated)
- Study completion
- 24 Dec 2025 (estimated)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label, Randomized, phase Ib/II clinical study to evaluate the anti-tumor efficacy, safety, tolerability, and PK of IN10018 in combination with anti-PD-1/L1 monoclonal antibody (Tislelizumab is proposed as the combination drug) and chemotherapy (platinum and etoposide) as the first-line treatment in Extensive-stage small cell lung cancer (ES-SCLC).
Detailed description
This study consists of 2 parts: 1) Phase Ib-Dose Confirmation part: To assess the PK parameters, safety and recommended phase II dose (RP2D) of IN10018 in combination with anti-PD-1/L1 monoclonal antibody (Tislelizumab is proposed as the combination drug), platinum (carboplatin is proposed as the combination drug) and etoposide as the first-line treatment in ES-SCLC. 2) Phase II-Dose Expansion part: To assess the antitumor efficacy, safety and tolerability in the experimental group of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to the control group of Tislelizumab in combination with carboplatin and etoposide as the first-line treatment in ES-SCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: IN10018, Drug: Tislelizumab, Drug: Carboplatin, Drug: EtoposideIN10018 in combination with Tislelizumab, carboplatin and etoposide as the first-line treatment in ES-SCLC. |
| Control group | Active comparator | Drug: Tislelizumab, Drug: Carboplatin, Drug: EtoposideTislelizumab in combination with carboplatin and etoposide as the first-line treatment in ES-SCLC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female aged 18-75 years old at the time of signing informed consent.
- Be able to understand and be willing to sign informed consent.
- Histologically confirmed ES-SCLC (according to the Veterans Administration Lung Study Group (VALG) staging system), which is not suitable for locally radical therapy.
- Has not received any systemic antitumor therapy for ES-SCLC.
- Has at least one measurable tumor lesion per RECIST 1.1.
Key exclusion criteria (18 listed)
- Has known active or untreated central nervous system (CNS) metastases, and/or carcinomatous meningitis.
- Spinal cord compression without surgery and/or radiation therapy, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for at least 7 days prior to the first dose of study treatment/randomization.
- Pleural, pericardial or abdominal effusion that are clinically symptomatic and require puncture or drainage.
- Symptomatic hypercalcemia.
- Malignancies other than the study disease within 3 years prior to the first dose of study treatment/randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IN10018Also: BI 853520orally taken once daily | Drug | Experimental group |
| Tislelizumab200mg D1, Q3W, intravenously | Drug | Control group, Experimental group |
| CarboplatinAUC 5 mg/ml/min, D1, Q3W, intravenously | Drug | Control group, Experimental group |
| EtoposideEtoposide 100 mg/m2, D1-D3, Q3W, intravenously | Drug | Control group, Experimental group |
Primary outcome
To identify the Recommended phase II dose (RP2D) of IN10018 in combination with Tislelizumab, Carboplatin and Etoposide in first-line ES-SCLC.
Time frame: Up to 3 years
Evaluate proportion of patients suffered with AEs defined as dose-limited toxicities (DLTs) per protocol; and RP2D will be determined per the incidence of AEs defined as DLTs.
Progress free survival (PFS) of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC per BICR based on RECIST 1.1
Time frame: Up to 3 years
Defined as the time from randomization to first documentation of disease progression or to death due to any cause, whichever comes first.
13 secondary outcomes
PFS of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC per investigator based on RECIST 1.1
Time frame: Up to 3 years
Objective response rate (ORR) of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC per BICR and investigator based on RECIST 1.1.
Time frame: Up to 3 years
Duration of objective response (DOR) of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC per BICR and investigator based on RECIST 1.1.
Time frame: Up to 3 years
Disease Control Rate (DCR) of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC per BICR and investigator based on RECIST 1.1
Time frame: Up to 3 years
Overall survival (OS) of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC.
Time frame: Up to 3 years
Number of patients with adverse event
Time frame: Up to 3 years
PK: AUC of IN10018 following single dose administration and at steady state
Time frame: Up to 3 years
PK: Cmax of IN10018 following single dose administration and at steady state
Time frame: Up to 3 years
PK: Ctrough of IN10018 following single dose administration and at steady state
Time frame: Up to 3 years
PK: Tmax of IN10018 following single dose administration and at steady state
Time frame: Up to 3 years
PK: t1/2 of IN10018 following single dose administration and at steady state
Time frame: Up to 3 years
PK: CL/F of IN10018 following single dose administration and at steady state
Time frame: Up to 3 years
PK: Vd/F of IN10018 following single dose administration and at steady state
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Zhao principal investigator
Peking University Cancer Hospital & Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IN10018, Tislelizumab and Carboplatin in people with Small Cell Lung Cancer Extensive Stage, run by InxMed (Shanghai) Co., Ltd. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shu Fang (86-15933968623, shu.fang@inxmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the Recommended phase II dose (RP2D) of IN10018 in combination with Tislelizumab, Carboplatin and Etoposide in first-line ES-SCLC. (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.