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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

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.

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.

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

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

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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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 study objectives

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 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

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

Computed Tomography

2017

Completed Phase 2

~2790

Crizotinib

2014

Completed Phase 3

~2960