NL-OMON52857招募中3 期
A Phase 3, Randomized, Open Label Study to Compare Nivolumab plus Concurrent Chemoradiotherapy (CCRT) followed by Nivolumab plus Ipilimumab or Nivolumab plus CCRT Followed by Nivolumab vs CCRT followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer - CA209-73
Bristol-Myers Squibb0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1) ECOG performance status <=1
- •2) Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4
- •N0-3 M0) pathologically-confirmed (including Cytology) NSCLC, according to 8th
- •TNM classification, that is amenable to definitive CCRT. Participants who are
- •not planned for potential curative surgical resection are eligible, except for
- •those foregoing surgery due to clinical contraindication for general
- •anesthesia/surgery. Participants must be evaluated by the site*s
- •multidisciplinary team (eg, medical oncologist, surgeon, radiologist) during
- •screening to assess the suitability of the participant for the study.
- •i) Overt cT4 disease. Vertebral invasive disease must not extend into the
- •spinal canal. OR
- •ii) Nodal status N2 or N3 must be proven (by biopsy in at least one N2 or N3
- •node, via EBUS, mediastinoscopy, or thoracoscopy) OR
- •iii) Nodal status N1 must be proven by biopsy in at least one N1 node, via
- •EBUS, mediastinoscopy or thoracoscopy for T3 disease, unless the lesion is
- •unamenable or the biopsy procedure is medically infeasible (must be documented
- •in the medical record)
- •Note: fine needle aspiration/cytology is acceptable for diagnosis and staging
- •3) Newly diagnosed and treatment-naïve, with no prior local or systemic
- •anticancer therapy given as primary therapy for locally advanced disease
- •4) Measurable disease per RECIST 1.1 criteria
- •5) All participants must have tissue submitted to a central laboratory during
- •screening, obtained within 3 months prior to enrollment. Biopsy should be
- •excisional, core needle or surgical specimen. Fine needle aspiration is
- •unacceptable for submission.
- •For entry into the maintenance therapy of the study, the below criteria must be
- •1) Note: Inclusion Criteria 4 a) was removed as per Protocol Amendment 02. ECOG
- •performance status <=1
- •2) No BICR-confirmed progressive disease per RECIST 1.1 during or after CCRT
- •3) No current or prior use of immunosuppressive medication within 14 days
- •before the first dose of maintenance immunotherapy, with the exceptions of
- •intranasal and inhaled corticosteroids or systemic corticosteroids at
- •physiological doses, which are not to exceed 10 mg/day of daily prednisone
- •equivalent. Systemic steroid administration required as prophylaxis against or
- •to manage toxicities arising from CCRT is allowed
- •4) Any toxicity from CCRT should resolve to Grade 1 or baseline (except for
- •Grade 2 fatigue, esophagitis or alopecia).
- •5) Participants in Arm A and Arm B that received nivolumab should NOT meet
- •discontinuation criteria for immunotherapy (Section 8.1.1 of the protocol).
排除标准
- •1) Any condition including medical, emotional, psychiatric, or logistical that,
- •in the opinion of the Investigator, would preclude the patient from adhering to
- •the protocol or would increase the risk associated with study participation or
- •study drug administration or interfere with the interpretation of safety
- •results (eg, a condition associated with diarrhea or acute diverticulitis)
- •2) Active infection requiring systemic therapy within 14 days prior to
- •randomization
- •3) Concurrent malignancy (present during screening) requiring treatment or
- •history of prior malignancy active within 2 years prior to randomization (ie.
- •participants with a history of prior malignancy are eligible if treatment was
- •completed at least 2 years before randomization and the participant has no
- •evidence of disease). Participants with history of prior early stage basal
- •/squamous cell skin cancer or non-invasive or in situ cancers that have
- •undergone definitive treatment at any time are also eligible.
- •4) Participants with an active, known or suspected autoimmune disease.
- •Participants with type I diabetes mellitus, hypothyroidism only requiring
- •hormone replacement, skin disorders(such as vitiligo, psoriasis, or alopecia)
- •not requiring systemic treatment, or conditions not expected to recur in the
- •absence of an external trigger are permitted to enroll
- •5) Participants with a condition requiring systemic treatment with either
- •corticosteroids (> 10 mg daily prednisone equivalent) or other
- •immunosuppressive medications within 14 days of start of randomization. Inhaled
- •or topical steroids, and adrenal replacement steroid doses > 10 mg daily
- •prednisone equivalent, are permitted in the absence of active autoimmune disease
- •6) Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4
- •antibody, or any other antibody or drug specifically targeting T-cell
- •co-stimulation or checkpoint pathways
- •7) Presence of pleural/pericardial effusion on CT scan and/or X-ray. Effusions
- •that are too small to be tapped safely are acceptable
- •8) Participants with EGFR mutation regardless of mutation type are excluded.
- •Non-squamous tumour with unknown EGFR mutation status must be tested for EGFR
- •9) Known ALK translocation and/or ROS1 rearrangement
- •10) History of organ or tissue transplant that requires systemic use of immune
- •suppressive agents
- •11) Known history of positive test for human immunodeficiency virus (HIV) or
- •acquired immunodeficiency syndrome (AIDS).
- •12) Previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
- •infection within 4 weeks prior to screening. Symptoms must have resolved and
- •based on investigator assessment in consultation with the medical monitor,
- •there are no sequelae that would place the participant at a higher risk of
- •receiving investigational treatment.
- •13) Prior/Concomitant Therapy
- •a) Prior thoracic radiotherapy. Exceptions are prior radiotherapies involving
- •the chest for clinical conditions other than lung cancers (eg, breast cancer)
- •of which the radiation field does not overlap with that of the disease under
- •study AND does not have FDG uptake at the previously irradiated area of the
- •lung per the PET scan performed during screening. All other prior radiotherapy
- •is allowed and must be completed at least 30 days prior to study treatment with
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