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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)
Must not have
Palliative RT (< 10 fractions) must have been completed at least 48 hours prior to study entry. Stereotactic or small field brain irradiation must have completed at least 1 week prior to study entry. Whole brain RT or other palliative RT must have been completed at least 2 weeks prior to study entry
No chemotherapy and/or immunotherapy allowed after step 1 registration
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
No Placebo-Only Group

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.
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.
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 below
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I can take care of myself and am up and about more than half of my waking hours.
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My lung cancer is ALK-positive and at stage IV.
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I can swallow pills whole.
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I have never taken lorlatinib for my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I completed my short radiation therapy over 2 days ago, and any brain or whole body radiation over 1 to 2 weeks ago.
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I have not received chemotherapy or immunotherapy after my initial registration.
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I have ongoing or repeated pancreatitis confirmed by tests.
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I do not have active inflammatory bowel disease or conditions affecting medication absorption.
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I do not have any serious infections right now.

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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to the date of last known follow-up. maximum follow-up time was 33.6 months, median 8.9 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR), Per Investigator Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Criteria
Secondary study objectives
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 more
Other study objectives
Agreement of Biopsy Mutation and Circulating Free Deoxyribonucleic Acid (cfDNA) Mutation Results

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
51%
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%
Cerebral infarction
1%
Dyspnoea
1%
Ischaemic stroke
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Crizotinib
2014
Completed Phase 3
~2960
Cisplatin
2013
Completed Phase 3
~3120
Lorlatinib
2018
Completed Phase 4
~460
Pemetrexed
2014
Completed Phase 3
~5550
Alectinib
2019
Completed Phase 3
~2810
Brigatinib
2019
Completed Phase 3
~1240
Carboplatin
2014
Completed Phase 3
~6120
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
13,886 Previous Clinical Trials
41,020,927 Total Patients Enrolled
NRG OncologyOTHER
237 Previous Clinical Trials
102,764 Total Patients Enrolled
Jessica LinPrincipal InvestigatorNRG Oncology

Media Library

Alectinib (ALK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03737994 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: No ALK-resistance mutations, I1171, Compound mutation, F1174, G1202 (including G1202del and G1202R), ALK L1198F mutation (alone or combination with ALK inhibitor), V1180, C1156Y, MET amplification, L1196 (including L1196M)
Non-Small Cell Lung Cancer Clinical Trial 2023: Alectinib Highlights & Side Effects. Trial Name: NCT03737994 — Phase 2
Alectinib (ALK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03737994 — Phase 2
~2 spots leftby Oct 2025
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