EUCTR2021-005487-22-PL进行中（未招募）1 期
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.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 192
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 histologically or cytologically confirmed diagnosis of metastatic (Stage IV) or locally advanced, unresectable Stage III nonsquamous NSCLC that has relapsed or progressed.
- •4. Have measurable disease as defined by RECIST v1.1 criteria based on local assessment with at least 1 target lesion that has not been previously irradiated.
- •5. PD-L1 expression status must be available prior to the study entry. No prespecified PD-L1 expression status is necessary for inclusion (or enrollment).
- •6. Can provide a tumor sample from an existing biopsy taken within 2 years prior to entering trial or have at least one lesion that is accessible for a fresh biopsy where safe and feasible.
- •7. Have relapsed or progressed after prior anti-PD-1/PD-L1 therapy as follows:
- •- Have received only 1 anti-PD-1/PD-L1 agent in the metastatic setting, without concomitant chemotherapy, and have radiographic progression at least 12 weeks after the start of the anty-PD-1/PD-L1 therapy. One cycle of chemotherapy while awaiting molecular testing results prior to starting the anti-PD-1/PD-L1 agent is allowed. Immuno-oncology (IO)/IO combination therapy (standard or investigational) is allowed.
- •- Have received anti-PD-1/PD-L1 therapy concurrently with and/or following chemoradiation in the Stage III unrespectable setting and have radiographic progression at least 6 months after the last doe of chemotherapy and at least 12 weeks after the start of the ant-PD-1/PD-L1 therapy. Immuno-oncology (IO)/IO combination therapy (standard or investigational) is allowed.
- •Note: Prior re-treatment with the same anti-PD-1/PD-L1 agent as well as prior SABR/SRS are allowed following progression on the anti-PD-1/PD-L1 regimen.
- •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: Total bilirubin =1.5× institutional upper limit of normal (ULN). For a participant with Gilbert's syndrome, total bilirubin =3.0x institutional ULN is allowed if the increase is predominantly unconjugated bilirubin.
- •- Alanine transaminase (ALT) and aspartate transaminase (AST): =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 or 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. Presence of symptomatic central nervous system (CNS) metastases or leptomeningeal disease.
- •a. Participants with asymptomatic untreated CNS metastases are eligible provided that immediate CNS-specific treatment is unlikely in the Investigator's judgment.
- •b. Participants with previously treated CNS metastases are eligible provided the are neurologically stable and, if receiving corticosteroids for CNS metastases, are on a stable or decreasing corticosteroid dose for at least 2 weeks prior to the start of study treatment.
- •c. In participations with known CNS metastases, baseline CNS imaging must be obtained within 4 weeks prior to the start of study treatment.
- •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. Received systematic therapies for NSCLC, in the metastatic or Stage III unrespectable setting, other than 6 those described in inclusion criterion 7.
- •4. Have actionable mutation or genomic alteration in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK), or ROS1. Additionally, participants with known RET or NTRK rearrangement, BRAF V600E mutation, HER2 mutation, or MET exon 14 skipping mutation are excluded if targeted therapy is available as local standard of care (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 PD-1/PD-L1 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 [>10mg daily prednisone equivalents], or immunosuppressive drugs) or persistent immune-mediated toxicity caused by checkpoint inhibitor therapy > Grade 1, 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 disc
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