PER-062-22招募中3 期
A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic NSCLC Without Actionable Genomic Alterations (D926NC00001; AVANZAR)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 31
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. Participant must be = 18 years at the time of screening. Type of Participant and Disease Characteristics
- •2. Histologically or cytologically documented NSCLC that:
- •(a) Is Stage IIIB or IIIC disease not amenable for surgical resection or definitive
- •chemoradiation, or Stage IV metastatic NSCLC disease at the time of randomisation
- •who have not received prior chemotherapy or other systemic therapy for first-line
- •Stage IIIB, IIIC or IV NSCLC. Participants who have received prior platinumcontaining
- •adjuvant, neoadjuvant, or definitive chemoradiation for early stage disease
- •(Stage I to IIIA) are eligible, provided that progression has occurred > 6 months from
- •the last dose of checkpoint inhibitor, chemotherapy, or other systemic anti-cancer
- •(b) Lacks sensitising EGFR tumour tissue mutation (eg, exon 19 deletion or exon 21
- •L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation), as well as
- •ALK and ROS1 rearrangements.
- •(c) Has no documented tumour genomic alteration results in NTRK, BRAF, RET, MET or
- •any other actionable driver oncogenes for which there are locally approved and
- •available targeted first-line therapies.
- •Note: Participants whose tumours harbour KRAS mutations are eligible for the study.
- •3. ECOG PS of 0 or 1 with no deterioration over the previous 2 weeks prior to day of first dosing.
- •4. FFPE tumour sample collected prior to signing of informed consent, ie, the start of screening (see Section 8.6.1.1 and the Laboratory Manual for further details).
- •5. Tumour PD-L1 status defined as TC < 1%, TC 1% to 49%, or TC = 50%, determined using the VENTANA PD-L1 (SP263) IHC Assay by a central laboratory. Participants with unknown central PD-L1 status are not eligible for the study.
- •6. TROP2 biomarker status as determined retrospectively using the VENTANA TROP2 IHC + QCS Assay (clinical trial assay), or prospectively once a TROP2 IHC + QCS assay is validated in a CAP/CLIA laboratory. Participants with unknown central TROP2 biomarker status are not eligible for the study once prospective testing is implemented.
- •7. At least 1 lesion, not previously irradiated, that qualifies as a target lesion (TL) per RECIST 1.1 at baseline and can be accurately measured at baseline as = 10 mm in the longest diameter (except lymph nodes, which must have short axis = 15 mm) with CT or MRI and is suitable for accurate repeated measurements.
- •8. Adequate bone marrow reserve and organ function within 7 days before randomisation defined as:
- •? Haemoglobin = 9.0 g/dL (red blood cell/plasma transfusion is not allowed within 1 week prior to screening assessment).
- •? Absolute neutrophil count = 1.5 × 109/L (granulocyte colony stimulating factor administration is not allowed within 1 week prior to screening assessment).
- •? Platelet count = 100 × 109/L (platelet transfusion is not allowed within 1 week prior to screening assessment).
- •? International normalised ratio/prothrombin time and either partial thromboplastin time or activated partial thromboplastin time = 1.5 × ULN.
- •? TBL = 1.5 × ULN or < 3 × ULN in the presence of documented Gilbert’s syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.
- •? ALT and AST = 3 × ULN (< 5 × ULN in participants with liver metastases).
- •? Calculated CrCL > 40 mL/min as determined by Cockcroft-Gault (using actual body weight).
- •CrCL = Weight (kg) × (140 – Age [years]) / 72 × serum creatinine (mg/dL)
- •CrCL = Weigh
排除标准
- •Medical Conditions
- •1 As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including active bleeding diseases, active infection, active ILD/pneumonitis, serious chronic gastrointestinal conditions associated with diarrhoea, psychiatric illness/social situations or significant cardiac conditions), or history of allogenic organ transplant, which, in the investigator’s opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol.
- •2 History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence, adequately resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin, lentigo maligna that has undergone potentially curative therapy or adequately treated in situ disease without evidence of disease.
- •3 Mixed small-cell lung cancer and NSCLC histology; sarcomatoid variant of NSCLC.
- •4 Persistent toxicities caused by previous anti-cancer therapy, excluding alopecia or vitiligo, not yet improved to Grade = 1 or baseline. Note: participants may be enrolled with some chronic, stable Grade 2 toxicities (defined as no worsening to > Grade 2 for at least 3 months prior to randomisation and managed with SoC treatment) which the investigator deems related to previous anti-cancer therapy, including (but not limited to):
- •? Chemotherapy-induced neuropathy.
- •Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss) after consultation with the AstraZeneca study clinical lead.
- •5 Active or prior documented autoimmune, connective tissue or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis, systemic lupus erythematosus, Sjögren’s syndrome, sarcoidosis (granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc.), autoimmune pneumonitis and autoimmune myocarditis. The following are exceptions to this criterion:
- •? Participants with vitiligo or alopecia.
- •? Participants with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement.
- •? Any chronic skin condition that does not require systemic therapy.
- •? Participants without active disease in the last 5 years may be included but only after consultation with the study clinical lead.
- •? Participants with coeliac disease controlled by diet alone.
- •6 Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 7 days prior to randomisation. Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants must have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of radiotherapy and study enrolment.
- •7 History of leptomeningeal carcinomatosis.
- •8 Clinically significant corneal disease.
- •9 Known active or uncontrolled hepatitis B or C virus infection. Participants are eligible if they:
- •(a) Have been curatively treated for hepatitis C virus infection as demonstrated clinically and by viral serologies.
- •(b) Have received hepatitis B viru
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