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Alkylating agents
Necitumumab + Chemotherapy for Non-Small Cell Lung Cancer (SQUIRE Trial)
Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 31 months
Awards & highlights
SQUIRE Trial Summary
This trial is testing a new drug to see if it's more effective than standard chemotherapy for lung cancer.
Who is the study for?
This trial is for adults with Stage IV squamous non-small cell lung cancer. Participants must have proper liver and kidney function, no severe side effects from previous treatments (except hair loss), and not be pregnant or breastfeeding. They should agree to use effective contraception, have tumor tissue available for testing, and cannot have had certain prior treatments or active infections.Check my eligibility
What is being tested?
The study tests necitumumab combined with standard chemotherapy drugs cisplatin and gemcitabine against the standard chemo alone in treating advanced lung cancer. The goal is to see if adding necitumumab improves patient outcomes compared to just using chemotherapy.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as infusion reactions, skin rash, electrolyte imbalances due to renal function changes; blood-related issues like anemia; fatigue; gastrointestinal problems like nausea or vomiting; and possible liver enzyme alterations.
SQUIRE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 31 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~31 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival Time (OS)
Secondary outcome measures
Malignant Neoplasms
Mean Change From Baseline in Patient Reported Outcomes (PRO) Using the European Quality of Life-5 Dimension (EQ-5D)
Number of Participants With a Serum Anti-Necitumumab Antibody Assessment
+5 moreSide effects data
From 2020 Phase 3 trial • 633 Patients • NCT0098211157%
Nausea
41%
Rash
36%
Anorexia
35%
Vomiting
30%
Constipation
30%
Diarrhoea
30%
Neutropenia
29%
Asthenia
29%
Fatigue
25%
Hypomagnesaemia
24%
Anaemia
18%
Cough
16%
Mucosal inflammation
15%
Dyspnoea
15%
Leukopenia
15%
Pyrexia
14%
Dry skin
14%
Dermatitis acneiform
13%
Oedema peripheral
13%
Weight decreased
13%
Dizziness
11%
Back pain
10%
Hypocalcaemia
10%
Pruritus
10%
Conjunctivitis
10%
Stomatitis
10%
Headache
10%
Alopecia
9%
Abdominal pain upper
9%
Paronychia
9%
Rash generalised
8%
Non-small cell lung cancer
8%
Hyponatraemia
7%
Hypokalaemia
7%
Epistaxis
7%
Haemoptysis
7%
Thrombocytopenia
7%
Blood creatinine increased
7%
Dysgeusia
6%
Fluid retention
6%
Abdominal pain
6%
Oral candidiasis
6%
Urinary tract infection
6%
Musculoskeletal pain
6%
Pain in extremity
6%
Depression
6%
Insomnia
6%
Hypertension
5%
Lymphopenia
5%
Dyspepsia
5%
Hirsutism
5%
Productive cough
5%
Hyperglycaemia
5%
Pneumonia
5%
Tinnitus
5%
Paraesthesia
4%
Pulmonary embolism
4%
Non-cardiac chest pain
2%
General physical health deterioration
2%
Convulsion
2%
Metastases to central nervous system
2%
Medication error
2%
Respiratory failure
2%
Deep vein thrombosis
1%
Peripheral ischaemia
1%
Multi-organ failure
1%
Peripheral embolism
1%
Pericardial effusion
1%
Sepsis
1%
Subclavian vein thrombosis
1%
Atrial fibrillation
1%
Atrial flutter
1%
Cardiac failure
1%
Cardiac tamponade
1%
Musculoskeletal chest pain
1%
Death
1%
Device related infection
1%
Infection
1%
Lung infection
1%
Neutropenic sepsis
1%
Incorrect dose administered
1%
Dehydration
1%
Ischaemic stroke
1%
Syncope
1%
Renal failure
1%
Renal failure acute
1%
Lacrimation increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Necitumumab+Pemetrexed+Cisplatin
Pemetrexed+Cisplatin
SQUIRE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Necitumumab + Gemcitabine + CisplatinExperimental Treatment3 Interventions
Group II: Gemcitabine + CisplatinActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Necitumumab
2013
Completed Phase 3
~1390
Gemcitabine
2017
Completed Phase 3
~2070
Cisplatin
2013
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
Thermo Fisher Scientific FSOTHER
1 Previous Clinical Trials
16 Total Patients Enrolled
Eli Lilly and CompanyLead Sponsor
2,624 Previous Clinical Trials
3,215,831 Total Patients Enrolled
ParexelIndustry Sponsor
305 Previous Clinical Trials
100,021 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- If you are a woman who could become pregnant, you need to have a negative pregnancy test within a week before joining the study.You have a condition called superior vena cava syndrome that makes it unsafe for you to receive fluids.You have had chemotherapy for advanced lung cancer, unless your last treatment was at least 1 year ago as part of a previous treatment plan.You have had radiation treatment to your chest in the past 12 weeks, except for palliative treatment to bone lesions.You have brain tumors that are causing symptoms or need ongoing treatment with medication. If you had brain tumors in the past but they are not causing symptoms now, you may be eligible.You currently have serious heart problems or uncontrolled congestive heart failure.You need to have stored tumor tissue that can be tested for specific gene mutations and gene copy number.You have a type of lung cancer called nonsquamous NSCLC, which includes adenocarcinoma or large cell types.Your kidneys work well enough.You have a current or ongoing infection that needs antibiotics, including tuberculosis or HIV.Your liver is working properly.You have been diagnosed with a specific type of lung cancer called squamous non-small cell lung cancer.You have a history of major brain or mental health conditions like dementia, seizures, or bipolar disorder.You have excessive fluid buildup that needs to be drained often.You had a heart attack within the past 6 months.You have a history of using drugs in a harmful way.You have another type of cancer that is not skin cancer or pre-cervical cancer that is not under control. If you had a different cancer before, it must have been at least 3 years since you were treated for it.You have cancer that can be measured or seen on scans according to specific guidelines. If your cancer cannot be measured, you may not be eligible.You have advanced (Stage IV) disease when starting the study.Your blood is working properly.You have moderate to severe peripheral neuropathy according to the NCI-CTCAE Version 3.0 grading system.You have received treatments targeting specific proteins related to cancer growth in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Necitumumab + Gemcitabine + Cisplatin
- Group 2: Gemcitabine + Cisplatin
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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