- |||||||||| Biomarker, Journal, PD(L)-1 Biomarker, IO Biomarker: Tissue and Blood Biomarkers in Lung Cancer: A Review. (Pubmed Central) - May 2, 2019
For predicting response to single agent pembrolizumab in the first-line treatment of patients with advanced adenocarcinoma or squamous cell NSCLCs, PD-L1 should be measured by an approved assay (e.g., PD-L1 IHC 22C3 pharmDx method)...Serum biomarkers may also be of use in determining prognosis and monitoring response to systemic therapies. With the increasing use of biomarkers, personalized treatment especially for patients with adenocarcinoma-type NSCLC is finally on the horizon.
- |||||||||| Clinical, Journal: Treatment of ALK-positive nonsmall cell lung cancer: recent advances. (Pubmed Central) - Apr 26, 2019
Our review will discuss the recent phase III data with ceritinib and alectinib as well as clinical trials with other ALK inhibitors. We will also address two important issues in the management of ALK-positive NSCLC, prevention and treatment of brain metastases and management of emergent ALK-TKI resistance mechanisms.
- |||||||||| Zykadia (ceritinib) / Novartis
Enrollment closed, Enrollment change, Combination therapy, Metastases: Ceritinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Locally Advanced or Metastatic Pancreatic Cancer (clinicaltrials.gov) - Apr 19, 2019 P1, N=38, Active, not recruiting, Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | N=96 --> 38
- |||||||||| Xalkori (crizotinib) / Pfizer, Zykadia (ceritinib) / Novartis
Journal, Heterogeneity: Genomic heterogeneity of ALK fusion breakpoints in non-small-cell lung cancer. (Pubmed Central) - Apr 17, 2019 Survival analysis of patients treated with targeted ALK inhibitors demonstrates a significant difference in mean survival between patients with next-generation sequencing confirmed EML4-ALK rearrangements, and those without (20.6 months vs 5.4 months, P<0.01). Together, these data demonstrate abundant genomic heterogeneity among ALK-rearranged lung adenocarcinoma, which may account for differences in treatment response with targeted ALK inhibitors.Modern Pathology advance online publication, 12 January 2018; doi:10.1038/modpathol.2017.181.
- |||||||||| Zykadia (ceritinib) / Novartis
Enrollment change, Metastases: Ceritinib Rare Indications Study in ALK+ Tumors (clinicaltrials.gov) - Apr 16, 2019 P2, N=22, Completed, Together, these data demonstrate abundant genomic heterogeneity among ALK-rearranged lung adenocarcinoma, which may account for differences in treatment response with targeted ALK inhibitors.Modern Pathology advance online publication, 12 January 2018; doi:10.1038/modpathol.2017.181. N=106 --> 22
- |||||||||| Clinical, Review, Journal: Lung Toxicity in Non-Small-Cell Lung Cancer Patients Exposed to ALK Inhibitors: Report of a Peculiar Case and Systematic Review of the Literature. (Pubmed Central) - Apr 10, 2019
...Crizotinib was responsible for pulmonary adverse events (AEs) in 1.8% of exposed patients (49 of 2706)...Pulmonary AEs during therapy with ceritinib, alectinib, and lorlatinib occurred in 1.1%, 2.6%, and 1.8% of the patients, respectively...Lung toxicity is a rare albeit potentially severe side effect in NSCLC patients receiving ALK-TKIs, apparently more frequent with brigatinib. Its early recognition and treatment are crucial for the best outcome of this subgroup of patients, whose overall prognosis is being improved by the availability of several targeted agents.
- |||||||||| Zykadia (ceritinib) / Novartis
Enrollment change, Metastases: Ceritinib Rare Indications Study in ALK+ Tumors (clinicaltrials.gov) - Mar 5, 2019 P2, N=106, Completed, Its early recognition and treatment are crucial for the best outcome of this subgroup of patients, whose overall prognosis is being improved by the availability of several targeted agents. N=22 --> 106
- |||||||||| Zykadia (ceritinib) / Novartis
Enrollment open, Trial initiation date, Trial primary completion date: A Study of LDK378 in Patients With Non-small Cell Lung Cancer Harboring ROS1 Rearrangement (clinicaltrials.gov) - Jan 11, 2019 P2, N=46, Recruiting, Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Dec 2018 --> Dec 2019 Not yet recruiting --> Recruiting | Initiation date: Jan 2018 --> Jul 2018 | Trial primary completion date: Dec 2019 --> May 2020
- |||||||||| Zykadia (ceritinib) / Novartis
Trial completion, Enrollment change, Metastases: Ceritinib Rare Indications Study in ALK+ Tumors (clinicaltrials.gov) - Dec 4, 2018 P2, N=22, Completed, Recruiting --> Active, not recruiting Recruiting --> Completed | N=106 --> 22
- |||||||||| Alunbrig (brigatinib) / Takeda
Journal: The brigatinib experience: a new generation of therapy for ALK-positive non-small-cell lung cancer. (Pubmed Central) - Nov 29, 2018 Brigatinib, a next-generation ALK inhibitor, shows promising activity in ALK-rearranged NSCLC that have previously received crizotinib with response rates in ALTA ranging from 42-50%, intracranial response 42-67% and median progression-free survival 9.2-12.9 months. Randomized Phase III trial, ALTA-1 L is investigating brigatinib in ALK inhibitor-naive patients.
- |||||||||| Review, Journal: Directed Therapies in Anaplastic Lymphoma Kinase-rearranged Non-small Cell Lung Cancer. (Pubmed Central) - Sep 16, 2018
Of considerable importance when considering such therapies is the ability of each to overcome mutations conferring acquired resistance, as well as penetrate the central nervous system (CNS), the most common site of metastasis and traditionally the most difficult to breach. Herein is a review of the efficacy, indications, and degree of CNS penetration for the ALK-targeting agents crizotinib, ceretinib, alectinib, brigatinib, and lorlatinib, as well as a summary of ongoing clinical trials comparing these drugs.
- |||||||||| Alunbrig (brigatinib) / Takeda
Trial initiation date, Metastases: ALTA-2: A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib (clinicaltrials.gov) - Aug 18, 2018 P2, N=103, Not yet recruiting, Herein is a review of the efficacy, indications, and degree of CNS penetration for the ALK-targeting agents crizotinib, ceretinib, alectinib, brigatinib, and lorlatinib, as well as a summary of ongoing clinical trials comparing these drugs. Initiation date: Jun 2018 --> Oct 2018
- |||||||||| Zykadia (ceritinib) / Novartis
Trial primary completion date: ASCEND-3: LDK378 in Crizotinib na (clinicaltrials.gov) - Aug 14, 2018 P2, N=125, Completed, Initiation date: Jun 2018 --> Oct 2018 Trial primary completion date: Jun 2014 --> Jan 2018
- |||||||||| Zykadia (ceritinib) / Novartis
Enrollment closed, Trial completion date, Trial primary completion date: Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK) (clinicaltrials.gov) - Jul 23, 2018 P1, N=83, Active, not recruiting, Active, not recruiting --> Completed | Trial completion date: Dec 2018 --> May 2018 Recruiting --> Active, not recruiting | Trial completion date: May 2018 --> Mar 2019 | Trial primary completion date: May 2018 --> Mar 2019
- |||||||||| Zykadia (ceritinib) / Novartis
Trial completion: ASCEND-3: LDK378 in Crizotinib na (clinicaltrials.gov) - Jul 20, 2018 P2, N=126, Completed, Recruiting --> Active, not recruiting | Trial completion date: May 2018 --> Mar 2019 | Trial primary completion date: May 2018 --> Mar 2019 Active, not recruiting --> Completed
- |||||||||| Zykadia (ceritinib) / Novartis, Kisqali (ribociclib) / Novartis
Trial primary completion date: NEPENTHE: Next Generation Personalized Neuroblastoma Therapy (clinicaltrials.gov) - Jul 19, 2018 P1, N=105, Recruiting, Active, not recruiting --> Completed Trial primary completion date: May 2018 --> Jul 2020
- |||||||||| Piqray (alpelisib) / Novartis, Zykadia (ceritinib) / Novartis, Tabrecta (capmatinib) / Incyte, Novartis
Trial completion date, Trial primary completion date, Metastases: A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - Jul 11, 2018 P2, N=67, Active, not recruiting, Trial primary completion date: May 2018 --> Jul 2020 Trial completion date: Aug 2018 --> Feb 2019 | Trial primary completion date: Aug 2018 --> Feb 2019
- |||||||||| Zykadia (ceritinib) / Novartis, Mekinist (trametinib) / Novartis, BeiGene
Enrollment open: Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma (clinicaltrials.gov) - Jun 21, 2018 P2, N=27, Recruiting, Trial completion date: Aug 2018 --> Feb 2019 | Trial primary completion date: Aug 2018 --> Feb 2019 Not yet recruiting --> Recruiting
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