CTRI/2024/01/061436招募中2 期
An open-label phase II trial evaluating the activity and safety of JDQ443 single-agent as first-line treatment for patients with locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer with a PD-L1 expression less than 1% or a PD-L1 expression = 1% and an STK11 co-mutation. - KontRASt-06
ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
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
入选标准
- •1 Participant is an adult = 18 years of age at the time of informed consent.
- •2 Histologically confirmed locally advanced (stage IIIb/IIIc not eligible for definitive chemoradiation or surgical resection with curative intent) or metastatic (stage IV) NSCLC without previous systemic treatment for metastatic disease. Prior (neo)adjuvant treatment with chemotherapy and/or immunotherapy, or prior radiotherapy administered sequentially or concomitantly with chemotherapy and/or immunotherapy for localized or locally advanced disease are accepted if the time between therapy completion and enrollment is > 12 months.
- •3 Presence of a KRAS G12C mutation (all participants) and:
- •Cohort A: PD-L1 expression < 1%, regardless of STK11 mutation status
- •Cohort B: PD-L1 expression = 1% and an STK11 co-mutation
- •4 At least one measurable lesion per RECIST 1.1.
- •ECOG performance status = 1.
- •5 Participants capable of swallowing study medication.
排除标准
- •1 Participants whose tumors harbor an EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing. Participants with other known druggable alterations will be excluded, if required by local guidelines
- •2 Previous use of a KRAS G12C inhibitor or previous systemic treatment for metastatic NSCLC.
- •3 A medical condition that results in increased photosensitivity (i.e. solar urticaria, lupus erythematosus, etc).
- •Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- •4 Participants who are taking a prohibited medication (strong CYP3A inducers) that cannot be discontinued at least seven days prior to the first dose of study treatment and for the duration of the study
研究者
相似试验
进行中（未招募）
不适用
Pilot study evaluating the efficacy and safety of preoperative ENDOTAG in combination with Paclitaxel in high risk breast cancerEUCTR2011-002985-19-BEJules Bordet Institute
进行中（未招募）
不适用
An open label phase II trial to assess the efficacy and safety of a once daily oral dose of 50 mg BIBW 2992 in two cohorts of patients with HER2-negative metastatic breast cancer after failure of no more than two chemotherapy regimen -HER2-negative metastatic breast cancer after failure of no more than two chemotherapy regimen in two cohorts of patientsTwo Cohorts: Cohort A: Triple negative metastatic breast cancer, i.e. HER2-negative, estrogen-receptor-negative and progesterone receptor negativeCohort B:HER2-negative, estrogen-receptor-positive and/or progesterone-receptor positiveMedDRA version: 8.1Level: LLTClassification code 10027475Term: Metastatic breast cancerEUCTR2006-002018-36-BESCS Boehringer Ingelheim Comm.V60
进行中（未招募）
不适用
An open label phase II trial to assess the efficacy and safety of a once daily oral dose of 50 mg BIBW 2992 in two cohorts of patients with HER2-negative metastatic breast cancer after failure of no more than two chemotherapy regimen -HER2-negative metastatic breast cancer after failure of no more than three chemotherapy regimen in two cohorts of patientsTwo Cohorts: Cohort A: Triple negative metastatic breast cancer, i.e. HER2-negative, estrogen-receptor-negative and progesterone receptor negativeCohort B:HER2-negative, estrogen-receptor-positive and/or progesterone-receptor positiveMedDRA version: 8.1Level: LLTClassification code 10027475Term: Metastatic breast cancerEUCTR2006-002018-36-DEBoehringer Ingelheim Pharma GmbH & Co. KG60
进行中（未招募）
不适用
An open label phase IIa trial to assess efficacy and tolerability of a once a week oral dose of 200 mg R126638 in disto-lateral toenail onychomycosis. - R126638 in toenail onychomycosisMedDRA version: 8.1Level: LLTClassification code 10030338Term: OnychomycosisOnychomycosisEUCTR2005-004611-30-NLBarrier Therapeutics nv20
已完成
2 期
An open label phase IIa trial to assess efficacy and tolerability of a once a week oral dose of 200 mg R126638 in disto-lateral toenail onychomycosis.toenail fungitoenail infections10040792NL-OMON29995Barrier Therapeutics20