Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)

Conditions

• Stage IB Lung Non-Small Cell Carcinoma AJCC v7
• Stage II Lung Non-Small Cell Cancer AJCC v7
• Stage IIA Lung Cancer AJCC v8
• Stage IIB Lung Cancer AJCC v8
• Stage IIIA Lung Cancer AJCC v8
• Stage IIIA Lung Non-Small Cell Cancer AJCC v7
• Stage IIIB Lung Cancer AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood samples
• Carboplatin — DRUG
  Given IV
• Cisplatin — DRUG
  Given IV
• Clinical Observation — OTHER
  Undergo observation
• Computed Tomography — PROCEDURE
  Undergo CT or PET/CT
• Crizotinib — DRUG
  Given PO
• Cytology Specimen Collection Procedure — OTHER
  Undergo collection of blood and tissue
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• Erlotinib — DRUG
  Given PO
• Gemcitabine Hydrochloride — DRUG
  Given IV
• Nivolumab — BIOLOGICAL
  Given IV
• Paclitaxel — DRUG
  Given IV
• Pembrolizumab — BIOLOGICAL
  Given IV
• Pemetrexed — DRUG
  Given IV
• Pemetrexed Disodium — DRUG
  Given IV
• Placebo Administration — OTHER
  Given PO
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT

Study Details

This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

Key Dates

Start date

Sep 26, 2014

Status verified

Feb 2026

Primary completion

Sep 28, 2026

Completion

Sep 28, 2026

Study Design

Enrollment

8,300 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Arms

• Experimental: A081105 Arm A (blinded erlotinib hydrochloride)
  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)
• Placebo Comparator: A081105 Arm B (placebo)
  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)
• Experimental: A081105 Arm C (unblinded erlotinib hydrochloride)
  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.
• Active Comparator: A081105 Arm D (observation)
  Patients (including patients previously randomized to placebo) undergo observation at least every 6 months for 2 years.
• Active Comparator: A081801 Arm A (platinum doublet, observation)
  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.
• Experimental: A081801 Arm B (platinum doublet, sequential pembrolizumab)
  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.
• Experimental: A081801 Arm C (platinum doublet, combination pembrolizumab)
  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.
• Experimental: E4512 Arm A (crizotinib)
  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.
• Active Comparator: E4512 Arm B (observation)
  Patients undergo observation.
• Experimental: EA5142 Arm I (nivolumab)
  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.
• Active Comparator: EA5142 Arm II (observation)
  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.

Primary Outcome Measure

Central and local clinical genotyping to facilitate accrual to the adjuvant Intergroup studies, E4512 and A081105 [ Time Frame: Up to 4 years ]

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