<a class="ci-mono font-sans text-ink no-underline hover:text-accent" href="/gene/ALK">ALK Fusion

Predictive

Supports Sensitivity Response

submitted

EID7546

In a phase I study of the efficacy of ceritinib in ALK fusion positive cancer, a single patient with anaplastic large cell lymphoma was treated with 750mg daily ceritinb and had a partial response. Du… (full text at CIViC)

PMID 24670165 · Shaw et al., 2014 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID11218

This trial enrolled 26 patients with anaplastic large cell lymphoma (ALCL). The groups received twice daily crizotinib at doses of either 165 or 280 mg/m2. 83% of the 165 mg/m2 ALCL patients had a com… (full text at CIViC)

PMID 28787259 · Mossé et al., 2017 · Open in CIViC

Colorectal Adenocarcinoma1

Colorectal Adenocarcinoma1
v::ALK Fusion	Crizotinib	Predictive	E	Supports Sensitivity Response	1	accepted	EID1334 26 colorectal adenocarcinoma samples were run on Affymetrix human Exon 1.0 arrays and a computational method that assessed differential 5' and 3' gene expression for each gene was used to find potenti… (full text at CIViC) PMID 19737969 · Lin et al., 2009 · Open in CIViC	civic

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID1334

26 colorectal adenocarcinoma samples were run on Affymetrix human Exon 1.0 arrays and a computational method that assessed differential 5' and 3' gene expression for each gene was used to find potenti… (full text at CIViC)

PMID 19737969 · Lin et al., 2009 · Open in CIViC

Diffuse Large B-Cell Lymphoma1

Diffuse Large B-Cell Lymphoma1
v::ALK Fusion	Crizotinib	Predictive	C	Supports Sensitivity Response	2	accepted	EID1264 A 27 year old female patient with advanced-stage IV, CD20 negative diffuse large B cell lymphoma (DLBCL). ALK rearrangement was determined by FISH, but the ALK fusion partner was not determined due to… (full text at CIViC) PMID 24330038 · Wass et al., 2014 · Open in CIViC	civic

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID1264

A 27 year old female patient with advanced-stage IV, CD20 negative diffuse large B cell lymphoma (DLBCL). ALK rearrangement was determined by FISH, but the ALK fusion partner was not determined due to… (full text at CIViC)

PMID 24330038 · Wass et al., 2014 · Open in CIViC

Inflammatory Myofibroblastic Tumor8

Inflammatory Myofibroblastic Tumor8
v::ALK Fusion	(diagnostic)	Diagnostic	C	Supports Positive	4	accepted	EID1783 Fluorescence in situ hybridization with a probe flanking the ALK gene at 2p23 and immunohistochemistry revealed ALK expression, suggesting ALK fusions in three cases of IMT. PMID 10383129 · Griffin et al., 1999 · Open in CIViC	civic
v::ALK Fusion	Brigatinib	Predictive	B	Supports Sensitivity Response	3	submitted	EID11290 In this single-arm, open-label, phase 1/2 trial 137 patients who had advanced malignancies, including ALK-rearranged NSCLC and two patients with inflammatory myofibroblastic tumour (IMT) were enrolled… (full text at CIViC) PMID 27836716 · Gettinger et al., 2016 · Open in CIViC	civic
v::ALK Fusion	Ceritinib	Predictive	B	Supports Sensitivity Response	3	submitted	EID11291 In this phase 1 study, oral ceritinib was administered to 59 patients in doses of 50 - 750 mg once daily to patients with advanced cancers harbouring genetic alterations in ALK. A total of 130 patient… (full text at CIViC) PMID 24670165 · Shaw et al., 2014 · Open in CIViC	civic
v::ALK Fusion	Ceritinib	Predictive	C	Supports Sensitivity Response	3	submitted	EID7547 In a phase I study of the efficacy of ceritinib in ALK fusion positive cancer, a single patient with inflammatory myofibroblastic tumor was treated with 750mg daily ceritinb and showed a partial respo… (full text at CIViC) PMID 24670165 · Shaw et al., 2014 · Open in CIViC	civic
v::ALK Fusion	Crizotinib	Predictive	A	Supports Sensitivity Response	3	accepted	EID11122 9 patients with ALK-positive inflammatory myofibroblastic tumour (IMT) enrolled in the PROFILE 1013 (NCT01121588) phase 1b single-arm, open-label, multi-centre study received crizotinib. ORR was 67% f… (full text at CIViC) PMID 29352732 · Gambacorti-Passerini et al., 2018 · Open in CIViC	civic
v::ALK Fusion	Crizotinib	Predictive	B	Supports Sensitivity Response	3	accepted	EID1243 As part of a phase 1 dose-escalation trial (NCT00939770), seven patients between ages 12 months and 22 years with relapsed or refractory inflammatory myofibroblastic tumors with ALK-rearrangement were… (full text at CIViC) PMID 23598171 · Mossé et al., 2013 · Open in CIViC	civic
v::ALK Fusion	Crizotinib	Predictive	B	Supports Sensitivity Response	3	accepted	EID7362 In this phase I/II study, 14 patients with metastatic or inoperable ALK-positive IMT were administered crizotinib orally twice daily in 28-day cycles as a single agent for an indefinite duration. The … (full text at CIViC) PMID 28787259 · Mossé et al., 2017 · Open in CIViC	civic
v::ALK Fusion	Lorlatinib	Predictive	C	Supports Sensitivity Response	4	submitted	EID11294 This case study was on an 18-year-old Caucasian female presenting with severe headaches. Brain MRI revealed multiple brain masses with the largest (5 cm) found in the anterior left frontal lobe. A met… (full text at CIViC) PMID 28713152 · Yuan et al., 2017 · Open in CIViC	civic

v::ALK Fusion

(diagnostic)

Diagnostic

Supports Positive

accepted

EID1783

Fluorescence in situ hybridization with a probe flanking the ALK gene at 2p23 and immunohistochemistry revealed ALK expression, suggesting ALK fusions in three cases of IMT.

PMID 10383129 · Griffin et al., 1999 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

submitted

EID11290

In this single-arm, open-label, phase 1/2 trial 137 patients who had advanced malignancies, including ALK-rearranged NSCLC and two patients with inflammatory myofibroblastic tumour (IMT) were enrolled… (full text at CIViC)

PMID 27836716 · Gettinger et al., 2016 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

submitted

EID11291

In this phase 1 study, oral ceritinib was administered to 59 patients in doses of 50 - 750 mg once daily to patients with advanced cancers harbouring genetic alterations in ALK. A total of 130 patient… (full text at CIViC)

PMID 24670165 · Shaw et al., 2014 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

submitted

EID7547

In a phase I study of the efficacy of ceritinib in ALK fusion positive cancer, a single patient with inflammatory myofibroblastic tumor was treated with 750mg daily ceritinb and showed a partial respo… (full text at CIViC)

PMID 24670165 · Shaw et al., 2014 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID11122

9 patients with ALK-positive inflammatory myofibroblastic tumour (IMT) enrolled in the PROFILE 1013 (NCT01121588) phase 1b single-arm, open-label, multi-centre study received crizotinib. ORR was 67% f… (full text at CIViC)

PMID 29352732 · Gambacorti-Passerini et al., 2018 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID1243

As part of a phase 1 dose-escalation trial (NCT00939770), seven patients between ages 12 months and 22 years with relapsed or refractory inflammatory myofibroblastic tumors with ALK-rearrangement were… (full text at CIViC)

PMID 23598171 · Mossé et al., 2013 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID7362

In this phase I/II study, 14 patients with metastatic or inoperable ALK-positive IMT were administered crizotinib orally twice daily in 28-day cycles as a single agent for an indefinite duration. The … (full text at CIViC)

PMID 28787259 · Mossé et al., 2017 · Open in CIViC

v::ALK Fusion

Lorlatinib

Predictive

Supports Sensitivity Response

submitted

EID11294

This case study was on an 18-year-old Caucasian female presenting with severe headaches. Brain MRI revealed multiple brain masses with the largest (5 cm) found in the anterior left frontal lobe. A met… (full text at CIViC)

PMID 28713152 · Yuan et al., 2017 · Open in CIViC

Lung Adenocarcinoma4
ALK G1202R AND v::ALK Fusion	Crizotinib	Predictive	C	Supports Resistance	3	accepted	EID1357 A patient with ALK-rearranged lung adenocarcinoma responded to crizotinib treatment and then had relapse. Biopsy was taken within half a month and total DNA was extracted from the sample. Exons 20-28,… (full text at CIViC) PMID 22277784 · Katayama et al., 2012 · Open in CIViC	civic
MET Amplification OR MET Exon 14 Skipping Mutation OR v::ALK Fusion OR v::ROS1 Fusion	Crizotinib	Predictive	B	Supports Sensitivity Response	3	submitted	EID11385 69 patients with lung adenocarcinoma from Beth Israel Deaconess Medical Center had their cancers submitted for genomic profiling to identify crizotinib-sensitive genomic events. There were 7 cases tha… (full text at CIViC) PMID 26791794 · Jorge et al., 2015 · Open in CIViC	civic
v::ALK Fusion	Crizotinib	Predictive	C	Supports Sensitivity Response	3	accepted	EID1691 In an evaluation of a patient with crizotinib-sensitive lung adenocarcinoma, an EML4-ALK-E13;A20 rearrangement was identified using CGP. The patient attained a reduction in the target lesions by 14.2… (full text at CIViC) PMID 25922291 · Le et al., 2015 · Open in CIViC	civic
v::ALK Fusion AND ALK I1171N	Crizotinib	Predictive	C	Supports Resistance	2	submitted	EID4633 In a stage IV lung adenocarcinoma patient, ALK I1171N was associated with acquired resistance to crizotinib monotherapy. An ALK gene rearrangement had been previously identified and was associated wi… (full text at CIViC) PMID 27565911 · Johnson et al., 2016 · Open in CIViC	civic

Lung Adenocarcinoma4

ALK G1202R AND v::ALK Fusion

Predictive

Supports Resistance

accepted

EID1357

A patient with ALK-rearranged lung adenocarcinoma responded to crizotinib treatment and then had relapse. Biopsy was taken within half a month and total DNA was extracted from the sample. Exons 20-28,… (full text at CIViC)

PMID 22277784 · Katayama et al., 2012 · Open in CIViC

MET Amplification OR MET Exon 14 Skipping Mutation OR v::ALK Fusion OR v::ROS1 Fusion

Predictive

Supports Sensitivity Response

submitted

EID11385

69 patients with lung adenocarcinoma from Beth Israel Deaconess Medical Center had their cancers submitted for genomic profiling to identify crizotinib-sensitive genomic events. There were 7 cases tha… (full text at CIViC)

PMID 26791794 · Jorge et al., 2015 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID1691

In an evaluation of a patient with crizotinib-sensitive lung adenocarcinoma, an EML4-ALK-E13;A20 rearrangement was identified using CGP. The patient attained a reduction in the target lesions by 14.2… (full text at CIViC)

PMID 25922291 · Le et al., 2015 · Open in CIViC

v::ALK Fusion AND ALK I1171N

Predictive

Supports Resistance

submitted

EID4633

In a stage IV lung adenocarcinoma patient, ALK I1171N was associated with acquired resistance to crizotinib monotherapy. An ALK gene rearrangement had been previously identified and was associated wi… (full text at CIViC)

PMID 27565911 · Johnson et al., 2016 · Open in CIViC

Lung Non-Small Cell Carcinoma29

Lung Non-Small Cell Carcinoma29
ALK G1202R AND v::ALK Fusion	Crizotinib	Predictive	C	Supports Resistance	1	submitted	EID4624 In a non-small cell lung cancer patient with acquired crizotinib resistance, the tumor had an ALK gene rearrangement and an ALK G1202R co-mutation. The ALK G1202R tumor was reported to be refractory t… (full text at CIViC) PMID 23729361 · Gainor et al., 2013 · Open in CIViC	civic
ALK G1269A AND v::ALK Fusion	Ceritinib	Predictive	D	Supports Sensitivity Response	3	accepted	EID1342 The NSCLC cell line MGH021-4, harboring SQSTM1-ALK G1269A, was 6 times more sensitive to ceritinib (80nM GI50) than crizotinib (500 nM) in proliferation assays and caused notable reductions in phospho… (full text at CIViC) PMID 24675041 · Friboulet et al., 2014 · Open in CIViC	civic
ALK G1269A AND v::ALK Fusion	Crizotinib	Predictive	C	Supports Resistance	2	submitted	EID4617 In a non-small cell lung cancer patient with acquired crizotinib resistance, the tumor had an ALK gene rearrangement and an ALK G1269A co-mutation. The ALK G1269A tumor was reported to be refractory t… (full text at CIViC) PMID 23729361 · Gainor et al., 2013 · Open in CIViC	civic
ALK G1269A AND v::ALK Fusion	Crizotinib	Predictive	C	Supports Resistance	2	submitted	EID4618 In a non-small cell lung cancer patient with a bone metastatic tumor harboring an ALK gene rearrangement and an ALK G1269A co-mutation, ALK G1269A was reported to be refractory to 12-month crizotinib … (full text at CIViC) PMID 23434628 · Huang et al., 2013 · Open in CIViC	civic
ALK G1269A AND v::ALK Fusion	Ensartinib	Predictive	B	Supports Sensitivity Response	3	submitted	EID8861 In this multicentre phase II study of ALK-positive NSCLC patients that progressed on crizotinib, the safety and efficacy of 225mg daily ensartinib was assessed. Objective responses were seen in 76 (52… (full text at CIViC) PMID 31628085 · Yang et al., 2020 · Open in CIViC	civic
ALK S1206Y AND v::ALK Fusion	Ceritinib	Predictive	C	Supports Sensitivity Response	2	submitted	EID2865 In a prospective study (NCT01283516) of 130 cancer patients, a non-small cell lung cancer patient harboring a S1206Y mutation in the ALK portion of the ALK rearrangement was associated with a 60% resp… (full text at CIViC) PMID 24670165 · Shaw et al., 2014 · Open in CIViC	civic
v::ALK Fusion	Alectinib	Predictive	A	Supports Sensitivity Response	5	accepted	EID1282 In this Phase II trial of 87 patients (NCT01871805), alectinib was assayed for safety and efficacy in ALK positive NSCLC that had progressed on crizotinib. Of 69 patients with measurable disease, 35 a… (full text at CIViC) PMID 26708155 · Shaw et al., 2016 · Open in CIViC	civic
v::ALK Fusion	Alectinib	Predictive	A	Supports Sensitivity Response	5	accepted	EID7284 In a phase 3 trial, 303 patients with NSCLC with ALK fusion were randomly assigned to alectinib arm (N=152) or crizotinib arm (N=151). PFS was significantly longer with alectinib than with crizotinib … (full text at CIViC) PMID 28586279 · Peters et al., 2017 · Open in CIViC	civic
v::ALK Fusion	Alectinib	Predictive	A	Supports Sensitivity Response	5	submitted	EID7533 In this phase II study the safety, efficacy, and pharmacokinetics of twice daily 600mg alectinib treatment was assessed in 138 patients with advanced NSCLC harboring ALK rearrangements (previously det… (full text at CIViC) PMID 26598747 · Ou et al., 2016 · Open in CIViC	civic
v::ALK Fusion	Alectinib	Predictive	A	Supports Sensitivity Response	5	submitted	EID7872 National Comprehensive Cancer Network (NCCN) guidelines recommend alectinib for advanced ALK-positive NSCLC who are previously untreated or previously treated with crizotinib, including those with bra… (full text at CIViC) PMID 30030733 · Paik et al., 2018 · Open in CIViC	civic
v::ALK Fusion	Alectinib	Predictive	A	Supports Sensitivity Response	5	accepted	EID8657 A randomized phase 3 trial (J-ALEX) of 207 Japanese ALK-positive NSCLC patients compared the efficacy and safety of alectinib (300mg twice daily) and crizotinib (250mg twice daily) in the first-line s… (full text at CIViC) PMID 28501140 · Hida et al., 2017 · Open in CIViC	civic
v::ALK Fusion	Alectinib	Predictive	A	Supports Sensitivity Response	5	accepted	EID12012 In this global phase 3 trial, 257 patients with ALK-positive Non-Small-Cell Lung Cancer were treated with either alectinib (n = 130) or chemotherapy (n = 127). 93.8 % of the patients who had received … (full text at CIViC) PMID 38598794 · Wu et al., 2024 · Open in CIViC	civic
v::ALK Fusion	Alectinib	Predictive	B	Supports Sensitivity Response	3	accepted	EID1272 In this initial report of a single-arm Phase I and II study (JapicCTI-101264) of alectinib (CH5424802), 46 patients with advanced or metastatic ALK-rearranged non small cell lung cancer (NSCLC) were a… (full text at CIViC) PMID 23639470 · Seto et al., 2013 · Open in CIViC	civic
v::ALK Fusion	Alectinib	Predictive	B	Supports Sensitivity Response	4	accepted	EID1279 In this Phase I trial (NCT01588028) in 47 patients, alectinib was assessed for its effectiveness in treating locally advanced or metastatic ALK-positive NSCLC that had progressed or been resistant to … (full text at CIViC) PMID 25153538 · Gadgeel et al., 2014 · Open in CIViC	civic
v::ALK Fusion	Alectinib	Predictive	C	Supports Sensitivity Response	3	accepted	EID1273 In this case study of a critically ill 29 year old male nonsmoker with advanced metastatic ALK-positive NSCLC, alectinib (CH5424802), was administered as first line treatment. Where most clinical tria… (full text at CIViC) PMID 26938871 · Yoshida et al., 2016 · Open in CIViC	civic
v::ALK Fusion	Brigatinib	Predictive	A	Supports Sensitivity Response	5	accepted	EID11121 The phase III ALTA-1L open-label randomized trial examined 275 NSCLC patients given brigatinib (137 patients) vs crizotinib (138 patients). Patients were ALK fusion positive by an FDA-approved diagno… (full text at CIViC) PMID 32780660 · Camidge et al., 2020 · Open in CIViC	civic
v::ALK Fusion	Brigatinib	Predictive	B	Supports Sensitivity Response	4	rejected	EID1323 Development of second generation ALK inhibitors has been underway in order to address resistance to first line treatments such as crizotinib in ALK-rearranged NSCLC. Brigatinib is a potent dual inhib… (full text at CIViC) PMID 26951079 · Wu et al., 2016 · Open in CIViC	civic
v::ALK Fusion	Brigatinib	Predictive	B	Supports Sensitivity Response	4	accepted	EID4835 In a phase II randomized trial we evaluated two regimens of Brigatinib in Crizotinib-refractory ALK-pos. NSCLC. They were randomly assigned (1:1) to oral Brigatinib 90 mg once daily (arm A) or 180 mg … (full text at CIViC) PMID 28475456 · Kim et al., 2017 · Open in CIViC	civic
v::ALK Fusion	Brigatinib	Predictive	B	Supports Sensitivity Response	3	submitted	EID7053 A single-arm, open-label, phase 1/2 trial showed that 51 (72% [60-82]) out of 71 patients with crizotinib-treated and crizotinib-naive ALK-rearranged NSCLC responded to the ALK inhibitor, Brigatinib. PMID 27836716 · Gettinger et al., 2016 · Open in CIViC	civic
v::ALK Fusion	Ceritinib	Predictive	A	Supports Sensitivity Response	5	accepted	EID7285 In a phase 3 trial, patients with previously treatmented NSCLC with ALK fusion were randomly assigned to ceritinib or chemotherapy. Ceritinib showed a significant improvement in median PFS compared w… (full text at CIViC) PMID 28602779 · Shaw et al., 2017 · Open in CIViC	civic
v::ALK Fusion	Ceritinib	Predictive	A	Supports Sensitivity Response	4	submitted	EID11190 In a phase 3 trial (ASCEND-4, NCT01828099), a comparison of the selective ALK inhibitor ceritinib (750 mg daily) to chemotherapy (cisplatin or carboplatin plus pemetrexed) in 376 untreated ALK-fusion… (full text at CIViC) PMID 28126333 · Soria et al., 2017 · Open in CIViC	civic
v::ALK Fusion	Ceritinib	Predictive	B	Supports Sensitivity Response	4	accepted	EID1175 Updated results from ASCEND-1 trial assessing safety and activity of ceritinib in ALK rearranged locally advanced or metastatic NSCLC. 255 patients were enrolled and received at least one dose of ceri… (full text at CIViC) PMID 26973324 · Kim et al., 2016 · Open in CIViC	civic
v::ALK Fusion	Ceritinib	Predictive	B	Supports Sensitivity Response	4	submitted	EID7535 This dose escalation phase 1 study examined the safety and efficacy of ceritinib in 122 NSCLC patients harboring ALK rearrangements (determined by break-apart FISH). Maximum tolerated dose (MTD) was d… (full text at CIViC) PMID 24670165 · Shaw et al., 2014 · Open in CIViC	civic
v::ALK Fusion	Crizotinib	Predictive	A	Supports Sensitivity Response	5	accepted	EID1187 In the Phase I study PROFILE 1001 (NCT00585195), a recommended crizotinib dose of 250 mg twice daily for 28 day cycles was established. Among 1,500 advanced NSCLC patients who were screened for ALK-re… (full text at CIViC) PMID 20979469 · Kwak et al., 2010 · Open in CIViC	civic
v::ALK Fusion	Crizotinib	Predictive	A	Supports Sensitivity Response	5	accepted	EID1198 This two arm Phase III study named PROFILE 1007 (NCT00932893) was performed to assess crizotinib vs. established chemotherapy in non-small cell lung cancer patients positive for ALK rearrangement (ass… (full text at CIViC) PMID 23724913 · Shaw et al., 2013 · Open in CIViC	civic
v::ALK Fusion	Crizotinib	Predictive	A	Supports Sensitivity Response	5	accepted	EID1199 This phase 3 trial named PROFILE 1014 (NCT01154140) compared crizotinib to established chemotherapy in first-line treatment for this disease. The study consisted of 343 patients with advanced or metas… (full text at CIViC) PMID 25470694 · Solomon et al., 2014 · Open in CIViC	civic
v::ALK Fusion	Crizotinib	Predictive	B	Supports Sensitivity Response	4	accepted	EID1200 This retrospective study of patients from the PROFILE 1001 and 1005 studies of crizotinib in advanced ALK-rearranged NSCLC assessed the potential benefit of crizotinib beyond progressive disease (CBPD… (full text at CIViC) PMID 24478318 · Ou et al., 2014 · Open in CIViC	civic
v::ALK Fusion	Crizotinib	Predictive	B	Supports Sensitivity Response	4	accepted	EID1201 This prospective Phase III study named Profile 1014 on NSCLC ALK-rearranged patients assessed intracranial disease control rate (IC-DCR) in the subset of patients entering the study with preexisting t… (full text at CIViC) PMID 27022118 · Solomon et al., 2016 · Open in CIViC	civic
v::ALK Fusion	Crizotinib	Predictive	B	Supports Sensitivity Response	3	accepted	EID1419 In a retrospective study comparing survival outcomes in a subgroup of 82 ALK-positive crizotinib-treated patients enrolled in a phase 1 clinical trial (NCT00585195), crizotinib therapy was associated … (full text at CIViC) PMID 21933749 · Shaw et al., 2011 · Open in CIViC	civic

ALK G1202R AND v::ALK Fusion

Predictive

Supports Resistance

submitted

EID4624

In a non-small cell lung cancer patient with acquired crizotinib resistance, the tumor had an ALK gene rearrangement and an ALK G1202R co-mutation. The ALK G1202R tumor was reported to be refractory t… (full text at CIViC)

PMID 23729361 · Gainor et al., 2013 · Open in CIViC

ALK G1269A AND v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID1342

The NSCLC cell line MGH021-4, harboring SQSTM1-ALK G1269A, was 6 times more sensitive to ceritinib (80nM GI50) than crizotinib (500 nM) in proliferation assays and caused notable reductions in phospho… (full text at CIViC)

PMID 24675041 · Friboulet et al., 2014 · Open in CIViC

ALK G1269A AND v::ALK Fusion

Predictive

Supports Resistance

submitted

EID4617

In a non-small cell lung cancer patient with acquired crizotinib resistance, the tumor had an ALK gene rearrangement and an ALK G1269A co-mutation. The ALK G1269A tumor was reported to be refractory t… (full text at CIViC)

PMID 23729361 · Gainor et al., 2013 · Open in CIViC

ALK G1269A AND v::ALK Fusion

Predictive

Supports Resistance

submitted

EID4618

In a non-small cell lung cancer patient with a bone metastatic tumor harboring an ALK gene rearrangement and an ALK G1269A co-mutation, ALK G1269A was reported to be refractory to 12-month crizotinib … (full text at CIViC)

PMID 23434628 · Huang et al., 2013 · Open in CIViC

ALK G1269A AND v::ALK Fusion

Ensartinib

Predictive

Supports Sensitivity Response

submitted

EID8861

In this multicentre phase II study of ALK-positive NSCLC patients that progressed on crizotinib, the safety and efficacy of 225mg daily ensartinib was assessed. Objective responses were seen in 76 (52… (full text at CIViC)

PMID 31628085 · Yang et al., 2020 · Open in CIViC

ALK S1206Y AND v::ALK Fusion

Predictive

Supports Sensitivity Response

submitted

EID2865

In a prospective study (NCT01283516) of 130 cancer patients, a non-small cell lung cancer patient harboring a S1206Y mutation in the ALK portion of the ALK rearrangement was associated with a 60% resp… (full text at CIViC)

PMID 24670165 · Shaw et al., 2014 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID1282

In this Phase II trial of 87 patients (NCT01871805), alectinib was assayed for safety and efficacy in ALK positive NSCLC that had progressed on crizotinib. Of 69 patients with measurable disease, 35 a… (full text at CIViC)

PMID 26708155 · Shaw et al., 2016 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID7284

In a phase 3 trial, 303 patients with NSCLC with ALK fusion were randomly assigned to alectinib arm (N=152) or crizotinib arm (N=151). PFS was significantly longer with alectinib than with crizotinib … (full text at CIViC)

PMID 28586279 · Peters et al., 2017 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

submitted

EID7533

In this phase II study the safety, efficacy, and pharmacokinetics of twice daily 600mg alectinib treatment was assessed in 138 patients with advanced NSCLC harboring ALK rearrangements (previously det… (full text at CIViC)

PMID 26598747 · Ou et al., 2016 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

submitted

EID7872

National Comprehensive Cancer Network (NCCN) guidelines recommend alectinib for advanced ALK-positive NSCLC who are previously untreated or previously treated with crizotinib, including those with bra… (full text at CIViC)

PMID 30030733 · Paik et al., 2018 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID8657

A randomized phase 3 trial (J-ALEX) of 207 Japanese ALK-positive NSCLC patients compared the efficacy and safety of alectinib (300mg twice daily) and crizotinib (250mg twice daily) in the first-line s… (full text at CIViC)

PMID 28501140 · Hida et al., 2017 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID12012

In this global phase 3 trial, 257 patients with ALK-positive Non-Small-Cell Lung Cancer were treated with either alectinib (n = 130) or chemotherapy (n = 127). 93.8 % of the patients who had received … (full text at CIViC)

PMID 38598794 · Wu et al., 2024 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID1272

In this initial report of a single-arm Phase I and II study (JapicCTI-101264) of alectinib (CH5424802), 46 patients with advanced or metastatic ALK-rearranged non small cell lung cancer (NSCLC) were a… (full text at CIViC)

PMID 23639470 · Seto et al., 2013 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID1279

In this Phase I trial (NCT01588028) in 47 patients, alectinib was assessed for its effectiveness in treating locally advanced or metastatic ALK-positive NSCLC that had progressed or been resistant to … (full text at CIViC)

PMID 25153538 · Gadgeel et al., 2014 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID1273

In this case study of a critically ill 29 year old male nonsmoker with advanced metastatic ALK-positive NSCLC, alectinib (CH5424802), was administered as first line treatment. Where most clinical tria… (full text at CIViC)

PMID 26938871 · Yoshida et al., 2016 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID11121

The phase III ALTA-1L open-label randomized trial examined 275 NSCLC patients given brigatinib (137 patients) vs crizotinib (138 patients). Patients were ALK fusion positive by an FDA-approved diagno… (full text at CIViC)

PMID 32780660 · Camidge et al., 2020 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

rejected

EID1323

Development of second generation ALK inhibitors has been underway in order to address resistance to first line treatments such as crizotinib in ALK-rearranged NSCLC. Brigatinib is a potent dual inhib… (full text at CIViC)

PMID 26951079 · Wu et al., 2016 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID4835

In a phase II randomized trial we evaluated two regimens of Brigatinib in Crizotinib-refractory ALK-pos. NSCLC. They were randomly assigned (1:1) to oral Brigatinib 90 mg once daily (arm A) or 180 mg … (full text at CIViC)

PMID 28475456 · Kim et al., 2017 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

submitted

EID7053

A single-arm, open-label, phase 1/2 trial showed that 51 (72% [60-82]) out of 71 patients with crizotinib-treated and crizotinib-naive ALK-rearranged NSCLC responded to the ALK inhibitor, Brigatinib.

PMID 27836716 · Gettinger et al., 2016 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID7285

In a phase 3 trial, patients with previously treatmented NSCLC with ALK fusion were randomly assigned to ceritinib or chemotherapy. Ceritinib showed a significant improvement in median PFS compared w… (full text at CIViC)

PMID 28602779 · Shaw et al., 2017 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

submitted

EID11190

In a phase 3 trial (ASCEND-4, NCT01828099), a comparison of the selective ALK inhibitor ceritinib (750 mg daily) to chemotherapy (cisplatin or carboplatin plus pemetrexed) in 376 untreated ALK-fusion… (full text at CIViC)

PMID 28126333 · Soria et al., 2017 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID1175

Updated results from ASCEND-1 trial assessing safety and activity of ceritinib in ALK rearranged locally advanced or metastatic NSCLC. 255 patients were enrolled and received at least one dose of ceri… (full text at CIViC)

PMID 26973324 · Kim et al., 2016 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

submitted

EID7535

This dose escalation phase 1 study examined the safety and efficacy of ceritinib in 122 NSCLC patients harboring ALK rearrangements (determined by break-apart FISH). Maximum tolerated dose (MTD) was d… (full text at CIViC)

PMID 24670165 · Shaw et al., 2014 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID1187

In the Phase I study PROFILE 1001 (NCT00585195), a recommended crizotinib dose of 250 mg twice daily for 28 day cycles was established. Among 1,500 advanced NSCLC patients who were screened for ALK-re… (full text at CIViC)

PMID 20979469 · Kwak et al., 2010 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID1198

This two arm Phase III study named PROFILE 1007 (NCT00932893) was performed to assess crizotinib vs. established chemotherapy in non-small cell lung cancer patients positive for ALK rearrangement (ass… (full text at CIViC)

PMID 23724913 · Shaw et al., 2013 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID1199

This phase 3 trial named PROFILE 1014 (NCT01154140) compared crizotinib to established chemotherapy in first-line treatment for this disease. The study consisted of 343 patients with advanced or metas… (full text at CIViC)

PMID 25470694 · Solomon et al., 2014 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID1200

This retrospective study of patients from the PROFILE 1001 and 1005 studies of crizotinib in advanced ALK-rearranged NSCLC assessed the potential benefit of crizotinib beyond progressive disease (CBPD… (full text at CIViC)

PMID 24478318 · Ou et al., 2014 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID1201

This prospective Phase III study named Profile 1014 on NSCLC ALK-rearranged patients assessed intracranial disease control rate (IC-DCR) in the subset of patients entering the study with preexisting t… (full text at CIViC)

PMID 27022118 · Solomon et al., 2016 · Open in CIViC

v::ALK Fusion

Predictive

Supports Sensitivity Response

accepted

EID1419

In a retrospective study comparing survival outcomes in a subgroup of 82 ALK-positive crizotinib-treated patients enrolled in a phase 1 clinical trial (NCT00585195), crizotinib therapy was associated … (full text at CIViC)

PMID 21933749 · Shaw et al., 2011 · Open in CIViC