IN10018 Combination Therapy in Treatment-naïve ES-SCLC

NCT06030258 | Recruiting Phase 1

• 1 other identifier: IN10018-019
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief 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 treatment in Extensive-stage small cell lung cancer (ES-SCLC).

Conditions

Small Cell Lung Cancer Extensive Stage

Keywords

First-line

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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.

  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.

  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

  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.

  Up to 3 years

Study Arms (2)

Experimental group

EXPERIMENTAL

IN10018 in combination with Tislelizumab, carboplatin and etoposide as the first-line treatment in ES-SCLC.

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

Drug: Tislelizumab; Drug: Carboplatin; Drug: Etoposide

Interventions

IN10018 DRUG

orally taken once daily

Also known as: BI 853520

Experimental group

Tislelizumab DRUG

200mg D1, Q3W, intravenously

Control group; Experimental group

Carboplatin DRUG

AUC 5 mg/ml/min, D1, Q3W, intravenously

Control group; Experimental group

Etoposide DRUG

Etoposide 100 mg/m2, D1-D3, Q3W, intravenously

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• InxMed (Shanghai) Co., Ltd.: lead

Study Sites (3)

Shandong Province Cancer Hospital

Jinan, China

RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

NOT YET RECRUITING

Henan Provincial People's Hospital

Zhengzhou, China

NOT YET RECRUITING

MeSH Terms

Interventions

tislelizumab; Carboplatin; Etoposide

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Jun Zhao

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu Fang

CONTACT

86-15933968623; shu.fang@inxmed.com

Lily Li

CONTACT

86-13911551669; lily.li@inxmed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: October 30, 2023
• Primary Completion: December 24, 2025
• Study Completion: December 24, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

CN (3)