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Genetic Testing

Genetic Testing for Early-Stage 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

For pre-surgical patients: Suspected diagnosis of resectable non-small cell lung cancer; patients with squamous cell carcinoma are eligible; Suspected clinical stage of IIIA, II (IIA or IIB) or large IB (defined as size >= 4 cm)

For post-surgical patients: Completely resected non-small cell lung cancer with negative margins (R0); patients with squamous cell carcinoma are eligible only if they have not received adjuvant therapy; Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size >= 4 cm); Eastern Cooperative Oncology Group (ECOG) performance status 0-1; Age ≥ 18 years; No patients who have received neoadjuvant therapy for this lung cancer; No locally advanced or metastatic cancer requiring systemic therapy within 5 years prior to registration; no secondary primary lung cancer diagnosed concurrently or within 2 year prior to registration; No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD-1/PD-L1/CTLA-4; No patients known to be pregnant or lactating; Patients who have had local genotyping are eligible, regardless of the local result; No patients with recurrence of lung cancer after prior resection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up 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.

Who is the study for?

This trial is for adults who've had surgery to remove non-small cell lung cancer that hasn't spread too far (stage IB-IIIA). They should be in good physical shape and not have had certain other cancers or treatments targeting specific genetic changes. Pregnant or breastfeeding individuals can't join, nor those with a recent second lung cancer.Check my eligibility

What is being tested?

The ALCHEMIST trial is looking at how genetic testing on tumor cells might guide treatment choices after surgery. It includes various interventions like CT scans, drug therapies (Crizotinib, Erlotinib, Nivolumab), chemotherapy agents (Carboplatin, Cisplatin), and observation methods to find the best approach.See study design

What are the potential side effects?

Possible side effects from the drugs tested could include nausea, fatigue, skin reactions, increased risk of infection due to immune system effects from Nivolumab and Pembrolizumab; liver issues from Crizotinib; and potential kidney or nerve damage from chemotherapy agents.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am suspected to have operable lung cancer that is not too advanced.

Select...

You must have had surgery to remove non-small cell lung cancer with clear margins. If you have squamous cell carcinoma, you can only join if you haven't had additional treatment after surgery. Your cancer should be at specific stages, and you should be in good physical condition. You must be at least 18 years old and not have had certain treatments before. You can't have other advanced cancers or be pregnant or breastfeeding. If your genes have been tested locally, you can still join the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

11Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: EA5142 Arm I (nivolumab)Experimental Treatment6 Interventions

Patients receive nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or PET/CT throughout the trial and blood sample collection during screening and follow-up. Patients may undergo an ECHO as clinically indicated.

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

Group VIII: E4512 Arm B (observation)Active Control2 Interventions

Patients undergo observation.

Group IX: EA5142 Arm II (observation)Active Control6 Interventions

Patients are followed serially with CT and/or PET/CT imaging for up to 1 year and then during follow-up. Patients also undergo blood sample collection during screening and follow-up. Patients may undergo an ECHO as clinically indicated on study.

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

Erlotinib

2011

Completed Phase 4

~2290

Computed Tomography

2017

Completed Phase 2

~2720

Echocardiography

2013

Completed Phase 4

~11670

Crizotinib

2014

Completed Phase 3

~2370

Biospecimen Collection

2004

Completed Phase 2

~1700

Carboplatin

2014

Completed Phase 3

~6670

Cisplatin

2013

Completed Phase 3

~1940

Gemcitabine Hydrochloride

2005

Completed Phase 3

~5420

Nivolumab

2014

Completed Phase 3

~4750

Paclitaxel

2011

Completed Phase 4

~5380

Pembrolizumab

2017

Completed Phase 2

~2010

Pemetrexed

2014

Completed Phase 3

~5250

Pemetrexed Disodium

2015

Completed Phase 2

~280

Positron Emission Tomography

2008

Completed Phase 2

~2240

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,666 Previous Clinical Trials

40,917,705 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: A081105 Arm C (unblinded erlotinib hydrochloride), A081801 Arm A (platinum doublet, observation), A081801 Arm C (platinum doublet, combination pembrolizumab), EA5142 Arm I (nivolumab), 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 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 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, Wisconsin."

Answered by AI