A randomized, double-blind, placebo-controlled, Phase 2 study evaluating efficacy and safety of inupadenant in combination with carboplatin and pemetrexed in adults with nonsquamous non-small cell lung cancer who have progressed on immunotherapy. - na

iTeos Belgium SA0 个研究点目标入组 192 人开始时间: 2023年1月17日最近更新: 2023年8月28日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方: iTeos Belgium SA
入组人数: 192

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•1. Have signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form prior to any study-specific evaluation.
•2. Be =18 years of age at the time informed consent is signed.
•3. Have a confirmed diagnosis of metastatic (Stage IV) or locally advanced, unresectable (Stage III) NSCLC of nonsquamous pathology that has relapsed or progressed.
•4. Have measurable disease as defined by RECIST v1.1 criteria based on local assessment. A measurable tumor lesion in a previously irradiated site is acceptable if subsequent progression has been demonstrated in that lesion.
•5. Have PD-L1 expression status available either at the time of or after the diagnosis of advanced or metastatic NSCLC disease has been made.
•6. Can provide existing biopsy taken within 2 years prior to entering trial or have at least one lesion that is accessible for a fresh biopsy (this lesion for fresh biopsy must not be the measurable target tumor lesion).
•7. Have relapsed or progressed after prior anti-programmed death (PD)-ligand (L)1 therapy as follows:
•- Have received only 1 line of anti- PD-L1 therapy in the metastatic setting, without concomitant chemotherapy, and have progressed on the anti-PD-(L)1 therapy. Immuno-oncology (IO)/IO combination therapy (standard or investigational) is allowed. Progression on the anti-PD-(L)1 therapy is defined as demonstrated radiological or clinical disease progression on or after at least 12 weeks of antiPD-(L)1 treatment.
•- Have received single-agent durvalumab therapy post-chemoradiation in the Stage III setting and have progressed. Progression on durvalumab therapy is defined as demonstrated radiological or clinical disease progression on or after at least 12 weeks of durvalumab treatment.
•8. Have adequate organ function confirmed by the following laboratory values obtained within 14 days prior to treatment assignment:
•Hematological:
•- Absolute neutrophil count: =1,500 /mL
•- Platelets: =100,000 /mL
•- Hemoglobin: =9.5 g/dL or =5.9 mmol/L– 4 weeks without transfusions
•- Estimated glomerular filtration rate (Modification of Diet in Renal Disease method) (Levey, 1999) = 60 mL/min
•- Total bilirubin OR Direct bilirubin: =1.5× upper limit of normal (ULN) for total
•bilirubin OR =ULN for direct bilirubin for subjects with elevated total bilirubin levels; =1.5× ULN for direct bilirubin in case of Gilbert’s syndrome (hereditary indirect hyperbilirubinemia)
•- Alanine transaminase and aspartate transaminase: =3× ULN; =5× ULN if liver metastases
•Coagulation
•- International Normalized Ratio (INR) or Prothrombin Time (PTT): =1.5× ULN unless the subject is receiving anticoagulant therapy.
•9. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 48
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 144

排除标准

•1. Symptomatic and/or untreated central nervous system (CNS) metastases or leptomeningeal disease. Participants with asymptomatic previously treated CNS metastases are eligible provided they have been clinically stable for at least 4 weeks.
•2. Presence of active second malignancy, except for:
•a. History of malignancy that has been successfully treated, with no evidence of active cancer for 1 year prior to enrollment
•b. Surgically cured and/or low risk tumors e.g., early stage cervical or endometrial cancer, any cancer in situ, non-melanoma skin cancers.
•3. Treatment with any prior systemic chemotherapy or >1 line of immunotherapy in the metastatic setting. Participants may have received prior chemotherapy or additional immunotherapy in the adjuvant setting, provided their first metastatic treatment occurred more than 6 months after completing adjuvant therapy).
•4. Have actionable mutation or genomic alteration in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genes or have been treated with EGFR or ALK targeted therapy. Participants with presence of other driver mutations are allowed if targeted therapy is not available as per local SOC.
•5. Preexisting gastrointestinal disorders/conditions that would, in the opinion of the Investigator, interfere with ingestion or absorption of inupadenant.
•6. History of or active (non-infectious) pneumonitis/ interstitial disease or lung fibrosis. (Note: Stage III participants with pneumonitis Grade 1 from the prior chemoradiation therapy that did not worsen on durvalumab therapy are allowed).
•7. Have active or a history of autoimmune disease requiring systemic treatment in the last 6 months (e.g., with disease modifying agents, corticosteroids, or immunosuppressive drugs) or persistent immune-mediated toxicity caused by checkpoint inhibitor therapy > Grade 2, with the exception of residual endocrinopathy being adequately treated, vitiligo, Type 1 diabetes mellitus (T1DM), or psoriasis not requiring systemic therapy. Replacement therapy (e.g., thyroxine, insulin, or corticosteroid replacement therapy for adrenal/pituitary insufficiency) is allowed.
•8. Have known active or chronic hepatitis B or C infection unless treated with antiviral therapy for at least 4 weeks with no detectable viral load at the time of screening; known infection with human immunodeficiency virus (HIV) unless receiving antiretroviral therapy with well-controlled disease documented at the time of screening by a CD4+ T-cell count > 350 cell/µL, HIV RNA level of < 50 copies/mL or the lower-limit of detection at least 12 weeks prior to screening, and a stable treatment regimen for at least 4 weeks prior to enrollment that has been limited to the use of abacavir, dolutegravir, emtricitabine, lamivudine, raltegravir, rilpivirine, or tenofovir. Participants are not required to be tested for the presence of such viruses prior to therapy on this protocol in the absence of a history of such infection or unless required by local health authorities.
•9. History of life-threatening toxicity related to prior immune therapy or any toxicity resulting in permanent discontinuation from prior therapy after rechallenge.
•Please refer to Protocol Section 3.5.2 for other exclusion criteria.

研究者

发起方

iTeos Belgium SA

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