IN10018 Combination Therapy in Treatment-naïve ES-SCLC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInxMed (Shanghai) Co., Ltd.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
IN10018
Drugorally taken once daily
Tislelizumab
Drug200mg D1, Q3W, intravenously
Carboplatin
DrugAUC 5 mg/ml/min, D1, Q3W, intravenously
Etoposide
DrugEtoposide 100 mg/m2, D1-D3, Q3W, intravenously
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 4 interventions
Group B: Control groupActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 3 years2
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.
Time frame
Up to 3 yearsSecondary outcomes
1
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.
Time frame
Up to 3 years2
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).
Time frame
Up to 3 years3
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.
Time frame
Up to 3 years4
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).
Time frame
Up to 3 yearsSponsors and contacts
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Source ClinicalTrials.gov