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
Qualifiers
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
Treatments tested in this trial
- IN10018
- Tislelizumab
- Carboplatin
- Etoposide
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov