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Genetic Testing

Genetic Testing for Lung Cancer

N/A
Recruiting
Led By David E Kozono
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
- Patients who have had local genotyping are eligible, regardless of the local result
- Tissue available for the required analyses (either clinical tissue block or slides and scrolls)
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 5 years
Awards & highlights

Study Summary

This trial looks at whether genetic testing can help select the best treatment for patients with early-stage non-small cell lung cancer.

Eligible Conditions
  • Lung Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have had surgery to remove your non-small cell lung cancer completely, with no remaining cancer cells. If you have squamous cell carcinoma, you can participate as long as you haven't received any additional treatment after surgery.
Select...
You have not received any previous treatments that target specific gene mutations or immune checkpoints.
Select...
You have squamous cell carcinoma, but you haven't received any additional treatment after your initial therapy.
Select...
You have a type of lung cancer called non-small cell lung cancer, specifically adenocarcinoma or adenosquamous histology.
Select...
You have previously had surgery to remove lung cancer, but it has not returned.
Select...
You have a type of cancer called squamous cell carcinoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Central and local clinical genotyping to facilitate accrual to the adjuvant Intergroup studies, E4512 and A081105
Feasibility of research grade formalin-fixed, paraffin-embedded tissue collection for Center for Cancer Genomics (CCG) analysis
Secondary outcome measures
Agreement of local genotyping methods (direct sequencing of EGFR, ALK fluorescence in situ hybridization [FISH]) with central Clinical Laboratory Improvement Amendments genotyping
Disease free survival (DFS) rate for lung cancers which are wild-type for EGFR and ALK
Other outcome measures
Proportions of patients who decline to enroll
Spectrum of new mutations identified at recurrence
Variability in the levels of baseline cell-free deoxyribonucleic acid (cfDNA) based on the timing of collection of these samples

Side effects data

From 2021 Phase 3 trial • 453 Patients • NCT03066778
54%
Neutropenia
45%
Anaemia
38%
Nausea
34%
Alopecia
31%
Decreased appetite
29%
Constipation
27%
Fatigue
26%
Thrombocytopenia
22%
Leukopenia
21%
Diarrhoea
20%
Cough
17%
Asthenia
17%
Dyspnoea
16%
Vomiting
14%
Pyrexia
14%
Dizziness
13%
Headache
13%
Arthralgia
13%
Rash
12%
Hypothyroidism
11%
Pruritus
11%
Insomnia
11%
Back pain
10%
Weight decreased
9%
Hyponatraemia
9%
Aspartate aminotransferase increased
8%
Pneumonia
8%
Oedema peripheral
8%
Upper respiratory tract infection
8%
Alanine aminotransferase increased
7%
Febrile neutropenia
7%
Abdominal pain
7%
Blood creatinine increased
7%
Hypokalaemia
6%
Abdominal pain upper
6%
Stomatitis
6%
Dry skin
6%
Erythema
6%
Dysgeusia
5%
Hyperthyroidism
5%
Dyspepsia
5%
Dysphagia
5%
Nasopharyngitis
5%
Blood alkaline phosphatase increased
5%
Pain in extremity
5%
Musculoskeletal chest pain
5%
Musculoskeletal pain
5%
Chest pain
5%
Hypertension
4%
Hypotension
4%
Urinary tract infection
2%
Atrial fibrillation
2%
Death
2%
Acute kidney injury
2%
Pneumonitis
2%
Pulmonary embolism
1%
Hemiparesis
1%
Clostridium difficile colitis
1%
Neutropenic sepsis
1%
Pleural infection
1%
Sepsis
1%
Infusion related reaction
1%
Diabetes mellitus
1%
Aortic aneurysm
1%
Inappropriate antidiuretic hormone secretion
1%
Pneumothorax
1%
Transient ischaemic attack
1%
Gastritis
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab+EP
Placebo+EP
Pembrolizumab Second Course

Trial Design

11Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: EA5142 Arm I (nivolumab)Experimental Treatment5 Interventions
Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) and/or positron emission tomography (PET)/CT throughout the trial and blood samples collection during screening and follow-up.
Group II: E4512 Arm A (crizotinib)Experimental Treatment2 Interventions
Patients receive crizotinib PO BID on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Group III: A081801 Arm C (platinum doublet, combination pembrolizumab)Experimental Treatment7 Interventions
INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens based on the treating physician's choice and pembrolizumab IV over 25-40 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. CONTINUANCE THERAPY: Patients then receive pembrolizumab IV over 25-40 minutes on day 1. Treatment repeats every 21 days for 13 cycles in the absence of disease progression or unacceptable toxicity.
Group IV: A081801 Arm B (platinum doublet, sequential pembrolizumab)Experimental Treatment7 Interventions
INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens based on the treating physician's choice. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. CONTINUANCE THERAPY: Patients then receive pembrolizumab IV over 25-40 minutes on day 1. Treatment repeats every 21 days for 17 cycles in the absence of disease progression or unacceptable toxicity.
Group V: A081105 Arm C (unblinded erlotinib hydrochloride)Experimental Treatment2 Interventions
Unblinded patients receive erlotinib hydrochloride PO QD on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Group VI: A081105 Arm A (blinded erlotinib hydrochloride)Experimental Treatment1 Intervention
Blinded patients receive erlotinib hydrochloride PO QD on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. (CLOSED 06/14/17)
Group VII: A081801 Arm A (platinum doublet, observation)Active Control7 Interventions
INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens based on the treating physician's choice. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. CONTINUANCE THERAPY: Patients then undergo observation.
Group VIII: E4512 Arm B (observation)Active Control2 Interventions
Patients undergo observation.
Group IX: EA5142 Arm II (observation)Active Control4 Interventions
Patients are followed serially with CT and/or PET/CT imaging for up to 1 year. Patients also undergo blood sample collection during screening and follow-up.
Group X: A081105 Arm D (observation)Active Control2 Interventions
Patients (including patients previously randomized to placebo) undergo observation at least every 6 months for 2 years.
Group XI: A081105 Arm B (placebo)Placebo Group2 Interventions
Patients receive placebo PO QD on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. (CLOSED 06/14/17)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2890
Crizotinib
2021
Completed Phase 3
~2120
Erlotinib
2011
Completed Phase 4
~2290
Biospecimen Collection
2004
Completed Phase 1
~1540
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Nivolumab
2014
Completed Phase 3
~4120
Paclitaxel
2011
Completed Phase 4
~5380
Pembrolizumab
2017
Completed Phase 3
~2030
Pemetrexed
2014
Completed Phase 3
~4270
Pemetrexed Disodium
2015
Completed Phase 2
~280
Positron Emission Tomography
2008
Completed Phase 2
~2240

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,487 Previous Clinical Trials
41,258,432 Total Patients Enrolled
David E KozonoPrincipal InvestigatorAlliance for Clinical Trials in Oncology
Geoffrey R OxnardPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Media Library

Biospecimen Collection (Genetic Testing) Clinical Trial Eligibility Overview. Trial Name: NCT02194738 — N/A
Lung Cancer Research Study Groups: EA5142 Arm I (nivolumab), A081801 Arm A (platinum doublet, observation), A081801 Arm C (platinum doublet, combination pembrolizumab), A081105 Arm C (unblinded erlotinib hydrochloride), A081105 Arm B (placebo), E4512 Arm B (observation), EA5142 Arm II (observation), E4512 Arm A (crizotinib), A081801 Arm B (platinum doublet, sequential pembrolizumab), A081105 Arm D (observation), A081105 Arm A (blinded erlotinib hydrochloride)
Lung Cancer Clinical Trial 2023: Biospecimen Collection Highlights & Side Effects. Trial Name: NCT02194738 — N/A
Biospecimen Collection (Genetic Testing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02194738 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is the clinical trial accepting at this time?

"That is accurate. As per data hosted on clinicaltrials.gov, this medical trial was first posted on August 18th 2014 and it is still actively recruiting patients; the study aims to enrol 8300 participants from 100 different sites."

Answered by AI

Are there opportunities for enrolment in this experiment yet?

"Affirmative, clinicaltrials.gov indicates that this research is actively enrolling participants. It was first advertised on August 18th 2014 and the most recent update came December 1st 2022. The goal of this trial is to recruit 8300 patients from 100 different sites."

Answered by AI

What diseases does Pembrolizumab usually prove efficacious for?

"Pembrozulimab is often employed to treat malignant melanoma of the skin, metastatic hepatocellular carcinomat malignant melanoma of the skin, metastatic hepatocellular carcinoma and neoplasm metastasis."

Answered by AI

In what areas are the trials of this experiment being conducted?

"This trial is primarily based at Aurora Health Care Germantown Health Center in Wisconsin, Aurora Cancer Care-Grafton in Minnesotaa Cancer Care-Grafton in Minnesota and Marshfield Medical Center-River Region in Iowa. An additional 100 sites are also participating across the country."

Answered by AI

Can you provide a catalogue of experiments utilizing Pembrolizumab?

"Originally studied at the City of Hope Comprehensive Cancer Center in 1997, pembrolizumab has now been explored through 3729 completed studies. Currently, 3179 active trials are being conducted with a substantial amount of this research taking place in Germantown, Wisconsine Cancer Center in 1997, pembrolizumab has now been explored through 3729 completed studies. Currently, 3179 active trials are being conducted with a substantial amount of this research taking place in Germantown, Wisconsin."

Answered by AI
Recent research and studies
~1902 spots leftby Sep 2026