Your session is about to expire
← Back to Search
ALK Inhibitor
ALK Inhibitors for Non-Small Cell Lung Cancer
Phase 2
Waitlist Available
Led By Jessica Lin
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Patients must have histologically or cytologically confirmed stage IV ALK-positive non-squamous non-small cell lung carcinoma (NSCLC) (includes M1a, M1b, M1c stage disease, American Joint Committee on Cancer [AJCC] 8th edition). ALK rearrangement must have been demonstrated by a Food and Drug Administration (FDA) approved assay (Vysis fluorescence in situ hybridization [FISH] or Ventana immunohistochemistry [IHC]) or by next generation sequencing (NGS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to the date of last known follow-up. maximum follow-up time was 33.6 months, median 8.9 months.
Awards & highlights
Study Summary
This trial is studying a combination of biomarker/ALK inhibitors to treat patients with stage IV ALK positive non-squamous non-small cell lung cancer.
Who is the study for?
This trial is for stage IV ALK positive non-squamous NSCLC patients who have progressed after one second-generation ALK inhibitor. They must not have had prior lorlatinib or more than one cycle of chemotherapy at diagnosis without progression. Participants need functioning major organs, no significant heart issues, and can't be pregnant or breastfeeding. Eligible individuals should not have other active cancers or serious illnesses that could affect safety.Check my eligibility
What is being tested?
The study tests combinations of biomarker/ALK inhibitors (Lorlatinib, Ceritinib, Alectinib, Brigatinib, Ensartinib, Crizotinib) against standard chemotherapy drugs (Pemetrexed, Cisplatin, Carboplatin) in treating advanced lung cancer with specific genetic changes. It aims to determine which treatment method is more effective.See study design
What are the potential side effects?
Potential side effects include liver problems from elevated bilirubin levels; blood disorders like low platelets or neutrophils; digestive issues due to the oral intake of medications; and possible interactions with existing medications. Brain metastases must be stable if present.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My lung cancer is ALK-positive and at stage IV.
Select...
I can swallow pills whole.
Select...
I have never taken lorlatinib for my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to the date of last known follow-up. maximum follow-up time was 33.6 months, median 8.9 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to the date of last known follow-up. maximum follow-up time was 33.6 months, median 8.9 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR), Per Investigator Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria
Secondary outcome measures
Duration of Overall Response, Per Investigator Assessment Using RECIST v1.1
Intracranial Objective Response Rate, Per Investigator Assessment Using RECIST v1.1
Number of Participants by Highest Grade Adverse Event Reported
+2 moreOther outcome measures
Agreement of Biopsy Mutation and Circulating Free Deoxyribonucleic Acid (cfDNA) Mutation Results
Side effects data
From 2012 Phase 3 trial • 256 Patients • NCT0100568051%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Cerebral infarction
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)
Trial Design
10Treatment groups
Experimental Treatment
Group I: V1180Experimental Treatment3 Interventions
Patients with V1180 mutation receive either lorlatinib PO QD, ceritinib PO QD, or brigatinib PO QD. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group II: No ALK-resistance mutationsExperimental Treatment8 Interventions
Patients with no ALK-resistant mutations receive either lorlatinib PO QD, ceritinib PO QD, alectinib PO BID, brigatinib PO QD, ensartinib PO QD, or pemetrexed IV over 10 minutes on day 1 with or without either cisplatin IV or carboplatin IV on day 1. ALK inhibitor cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Pemetrexed-based treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Maintenance treatment of pemetrexed may continue until disease progression or unacceptable toxicity.
Group III: MET amplificationExperimental Treatment1 Intervention
Patients with MET amplification receive crizotinib PO QD. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group IV: L1196 (including L1196M)Experimental Treatment6 Interventions
Patients with L1196 (including L1196M) mutation receive either lorlatinib PO QD, ceritinib PO QD, alectinib PO BID, brigatinib PO QD, or ensartinib PO QD. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group V: I1171Experimental Treatment3 Interventions
Patients with I1171 mutation receive either lorlatinib PO QD, ceritinib PO QD, or brigatinib PO QD. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group VI: G1202 (including G1202del and G1202R)Experimental Treatment2 Interventions
Patients with G1202 (including G1202del and G1202R) receive either lorlatinib PO QD or brigatinib PO QD. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group VII: F1174Experimental Treatment3 Interventions
Patients with F1174 receive either lorlatinib PO QD, alectinib PO BID, or brigatinib PO QD. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group VIII: Compound mutationExperimental Treatment1 Intervention
Patients with a compound mutation receive lorlatinib PO QD. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group IX: C1156YExperimental Treatment3 Interventions
Patients with Cy1156Y mutation receive either lorlatinib PO QD, alectinib PO BID, or brigatinib PO QD. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group X: ALK L1198F mutation (alone or combination with ALK inhibitor)Experimental Treatment1 Intervention
Patients with ALK L1198F mutation (alone or in combination with another ALK mutation) receive crizotinib PO QD. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
2014
Completed Phase 3
~5250
Cisplatin
2013
Completed Phase 3
~1940
Crizotinib
2014
Completed Phase 3
~2370
Lorlatinib
2018
Completed Phase 4
~440
Alectinib
2015
Completed Phase 3
~2400
Brigatinib
2018
Completed Phase 3
~890
Carboplatin
2014
Completed Phase 3
~6670
Ceritinib
2013
Completed Phase 3
~1030
Ensartinib
2017
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,657 Total Patients Enrolled
NRG OncologyOTHER
231 Previous Clinical Trials
100,842 Total Patients Enrolled
Jessica LinPrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have serious heart problems like uncontrolled high blood pressure or recent heart attacks.I am not on medications that would interfere with the study drug.I have brain metastases but also have a measurable cancer lesion outside the brain.I have ongoing or repeated pancreatitis confirmed by tests.I have brain metastases but no symptoms, or they are treated, and I have stable health.I can take care of myself and am up and about more than half of my waking hours.I do not have any serious illness or organ problems that could affect my safety or the study.I haven't had major surgery in the last 2 weeks, but minor procedures are okay.Your platelet count is at least 100,000 cells per cubic millimeter within the last 28 days before joining the study.I completed my short radiation therapy over 2 days ago, and any brain or whole body radiation over 1 to 2 weeks ago.My lung cancer is ALK-positive and at stage IV.I can swallow pills whole.I have not received chemotherapy or immunotherapy after my initial registration.Your liver enzyme levels are not too high, unless you have cancer that has spread to your liver.I am willing to have a new biopsy or use a recent one if it's available.Your white blood cell count is at least 1500 cells per cubic millimeter.I have only ALK-positive non-squamous NSCLC and no other cancers in the last 2 years, except for certain treated or in remission cancers.I am not pregnant or breastfeeding and agree to use contraception or abstain from sex during the study.I do not have active inflammatory bowel disease or conditions affecting medication absorption.I've had only one chemotherapy session for my metastatic NSCLC without disease progression, or it's been over a year since my last adjuvant or neoadjuvant chemotherapy.Your AST levels in the blood should not be too high, unless you have liver metastases, in which case it can be a little higher but still within a certain limit.Your bilirubin levels are within a certain range, unless you have been diagnosed with Gilbert's syndrome.My cancer has worsened after treatment with one specific ALK inhibitor.I have never taken lorlatinib for my condition.My side effects from previous treatments are mild or gone, except for hair loss or hearing loss.I have taken a specific lung cancer medication within the last 5-7 days.I do not have any serious infections right now.My kidneys are functioning well, with a creatinine clearance rate of at least 60 mL/min.I have had lung conditions like pneumonitis or fibrosis, but not from radiation.
Research Study Groups:
This trial has the following groups:- Group 1: No ALK-resistance mutations
- Group 2: I1171
- Group 3: Compound mutation
- Group 4: F1174
- Group 5: G1202 (including G1202del and G1202R)
- Group 6: ALK L1198F mutation (alone or combination with ALK inhibitor)
- Group 7: V1180
- Group 8: C1156Y
- Group 9: MET amplification
- Group 10: L1196 (including L1196M)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you outline which other research initiatives have incorporated Pemetrexed?
"In 1997, the City of Hope Comprehensive Cancer Center initiated clinical trials examining pemetrexed. To date, 1936 studies have been finalized and 1324 additional investigations are yet to be completed; a large portion of these active experiments are based in Cape Girardeau, Missouri."
Answered by AI
Are there any current opportunities to participate in this investigation?
"Clinicaltrials.gov reveals that this medical study is not currently recruiting patients, with its first post dating back to April 1st 2019 and its most recent update going as far back as September 23rd 2022. However, numerous other trials are actively enrolling participants at present - 3232 in total."
Answered by AI
What risks do patients bear when taking Pemetrexed?
"Pemetrexed is estimated to be a safe drug, with an assigned score of 2. This classification reflects the fact that there is some evidence for its safety but no data has been collected on efficacy yet."
Answered by AI
How many sites are currently involved in administering this research?
"This trial is taking place in 100 distinct sites, a few of which are located in Cape Girardeau, Honolulu and Springfield. To reduce the travel burden on participants, it is recommended to select the nearest clinic if enrolling."
Answered by AI
How many volunteers have enrolled in this medical experiment?
"This particular trial is no longer attempting to recruit participants; its initial posting was April 1st 2019 and the latest update occurred on September 23rd 2022. Currently, there are 1908 studies admitting patients with stage IVA lung cancer ajcc v8 and 1324 trials taking partakers undergoing Pemetrexed treatment."
Answered by AI
What ailments does Pemetrexed typically target?
"Pemetrexed is a go-to medication for treating advanced head and neck cancer. Additionally, its efficacy extends to malignant neoplasms, unresectable thymoma, and mesotheliomas."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger