2024-514586-20-01招募中3 期
IFCT-1701 DICIPLE A randomized phase 3 trial comparing continuation Nivolumab-Ipilimumab doublet immunotherapy until progression versus observation in treatment-naive patients with stage IV Non-Small Cell Lung Cancer (NSCLC) after Nivolumab-Ipilimumab induction treatment
Intergroupe Francophone De Cancerologie Thoracique58 个研究点 分布在 1 个国家目标入组 1,360 人开始时间: 2025年1月21日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,360
- 试验地点
- 58
- 主要终点
- Progression Free Survival (PFS1)
研究概览
简要总结
To observe not significantly different median 1st Progression-Free Survival (=PFS) from the date of randomization (thus in disease controlled patients) for the 'stop and go' arm B, as compared to the standard arm A with induction immunotherapy, followed by cisplatin-based chemotherapy at progression.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Signed Written Informed Consent: • Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care. • Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
- •Available tumor samples for centralized PD-L1 immunohistochemistry analysis
- •PD-L1 tumor content as assessed locally by the investigator center
- •Adequate biological functions: Creatinine Clearance ≥ 50 mL/min (Cockroft or MDRD or CKD-epi); neutrophiles ≥ 1500/mm3 ; platelets ≥100 000/mm3 ; Hemoglobin ≥ 9g/dL ; AST and ALT < 3x ULN, total bilirubine ≤ 1,5 x ULN except for patients with proved Gilbert syndrome or patients with hepatic metastases who must have AST and ALT ≤ 5 x ULN and a baseline total bilirubine ≤ 3,0 mg/dL.
- •Women of childbearing potential (WOCBP) and sexually active should use an efficacious contraception method within the 28 days preceding the first dose and during the 6 months following the last dose of treatment. Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. For Male subjects who are sexually active with WOCBP, an efficacious contraception method should be used during the treatment and during the 7 months following the last dose. Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of < 1% when used consistently and correctly. At a minimum, subjects must agree to the use of two methods of contraception, with one method being highly effective and the other method being either highly effective or less effective.
- •Patient inclusion validated by a multidisciplinary meeting.
- •Histologically-proven NSCLC (squamous or non-squamous). A cytologically-proven NSCLC is allowed if a cytoblock has been prepared.
- •Stage IV (M1, including M1a pleural involvement) disease (8th classification TNM, UICC 2015)
- •ECOG PS ≤ 1
- •Weight loss< 10% in previous 3 months
- •No prior systemic anticancer therapy (including EGFR or ALK inhibitors) given as primary therapy for advanced or metastatic disease.
- •Age≥ 18 years, <75 years
- •Life expectancy > 3 months
- •Measurable tumor disease by CT or MRI per RECIST 1.1 criteria
排除标准
- •Small cell lung cancer or tumors with mixt histology including a SCLC component
- •History of active autoimmune disease including rheumatoid polyarthritis, Lupus, Wegener disease. Patients with type I diabetes, or hypothyroïdy, or immune cutaneous disease (vitiligo, psoriasis, alopecia) not needing any immunosuppressive systemic treatment, are allowed to be included.
- •Active inflammatory intestinal disease (diverticulosis, Crohn disease, Hemorrhagic recto-colitis, coeliac disease) or any serious chronic intestinal disease with uncontrolled diarrhea
- •Active uncontrolled infection including tuberculosis, known acute viral hepatitis B and C according to serological tests. Patients with serological sequellae of cured viral hepatitis are allowed to be included.
- •HIV known infection
- •Living attenuated vaccine received within the 30 previous days
- •Previous treatment with anti-PD-1, anti-PD-L1 or Anti-CTLA4 antibody
- •Previous treatment with chemotherapy
- •General serious condition such as congestive uncontrolled cardiac failure, uncontrolled cardiac arythmia, uncontrolled ischemic cardiac disease (unstable angina or history of myocardial infarction in the previous 6 months), history or stroke within the 6 previous months
- •Pre-existing lung interstitial disease as assessed by the diagnosis CT-scan.
- •Known EGFR activating tumor mutation (deletion LREA in exon 19, L858R ou L861X mutations in exon 21, G719A/S mutation in exon 18) or HER exon 20 insertion (either tissue or plasma cfDNA mutation).
- •Known ALK or ROS1 gene rearrangement as assessed by IH, FISH or NGS sequencing
- •Previous or active cancer within the previous 5 years (except for treated carcinoma in situ of the cervix or basal cell skin cancer). Patients with a prostate adenocarcinoma history within the previous 5 years could be included in case of localized prostate cancer, with good prognostic factors according to d'Amico classification (≤ T2a and Score de Gleason ≤ 6 and PSA (ng/ml) ≤ 10), provided they were treated in a curative way (surgery or radiotherapy, without any chemotherapy)
- •Superior vena cava syndrome persisting after VCS stenting
- •Thoracic radiotherapy needed at initiation of tumor treatment, except bone palliative radiotherapy on a painful or compressive metastasis, respecting 2 weeks delay between the end of radiotherapy and the beginning of induction immunotherapy treatment
- •Symptomatic untreated brain metastasis (without previous whole brain radiotherapy or stereotactic ablative brain radiotherapy or without surgical resection). At least 4 weeks delay between the end of radiotherapy and the beginning of induction immunotherapy treatment should be respected. Asymptomatic brain metastasis, not needing corticosteroids greater than 10 mg prednisone equivalent daily or mannitol infusions, are allowed.
- •History of previous primary immunodeficiency, organ transplantation needing an immunosuppressive treatment, any immunosuppressive drug within 28 days before randomization date, or history of severe toxicity (grade 3/4) by immune mechanism linked to another immunotherapy treatment.
- •Systemic treatment with corticosteroids with greater dose than 10 mg prednisone equivalent daily, within 14 days before initiation of the immunotherapy induction. Inhaled, nasal or topic corticosteroids are allowed.
结局指标
主要结局
Progression Free Survival (PFS1)
Progression Free Survival (PFS1)
次要结局
- Progression Free Survival (PFS2)
- Quality of life (QoL)
- Overall survival (OS)
- Biological correlative exploratory studies (PD-L1)
- Biological correlative exploratory studies (PD-L1 H score)
- Biological correlative exploratory studies (CD3/CD8)
- Biological correlative exploratory studies (neutrophil)
- Biological correlative exploratory studies (cytokines)
- Biological correlative exploratory studies (chemokines)
研究者
Contact
Scientific
Intergroupe Francophone De Cancerologie Thoracique
研究点 (58)
Loading locations...
相似试验
已完成
3 期
Randomized phase III trial of irinotecan in combination with capecitabine or fluorouracil (5-FU)/leucovorin (LV) and bevacizumab as first-line treatment in patients with metastatic colorectal cancerMetastatic colorectal cancerCancer - Bowel - Back passage (rectum) or large bowel (colon)ACTRN12610000270011Hellenic Cooperative Oncology Group309
招募中
1 期
A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of two formulations of vaginal micronized progesterone.infertilityCTIS2024-513102-57-00Santiago Dexeus Font Fundacio Privada1,020
进行中（未招募）
不适用
A Randomized Phase III Trial Comparing Sequential Therapy With TPF/Chemoradiation (ST) To Cisplatin-Based Chemoradiotherapy with Accelerated Concomitant Boost Radiotherapy (CRT) For Locally Advanced Squamous Cell Cancer of the Head and Neck - The Paradigm TrialSquamous cell carcinoma of the head and neck [SCCHN].MedDRA version: 9.1Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neckEUCTR2006-007076-15-DEDana Farber Cancer Institute330
进行中（未招募）
1 期
A randomised controlled phase III trial comparing hyperthermia plus mitomycin to a second course of bacillus Calmette-Guerin or standard therapy in patients with recurrence of non-muscle invasive bladder cancer following induction or maintenance bacillus Calmette-Guerin therapy. - Hyperthermia plus mitomycin (HYMN)on muscle invasive bladder cancerMedDRA version: 9.1 Level: LLT Classification code 10005006 Term: Bladder cancer stage 0, with cancer in situMedDRA version: 9.1 Level: LLT Classification code 10005007 Term: Bladder cancer stage 0, without cancer in situMedDRA version: 9.1 Level: LLT Classification code 10005008 Term: Bladder cancer stage I, with cancer in situMedDRA version: 9.1 Level: LLT Classification code 10005009 Term: Bladder cancer stage I, without cancer in situEUCTR2008-005428-99-GBniversity College London104
已完成
3 期
Study to find out if restricting raw fruits in patients with blood cancer can reduce infections.CTRI/2018/01/011418Cancer Institute200