RESEARCH STUDIES & Clinical Trials

Clinical Trial ID: NCT02194738 Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

Status

Open

Description

This phase III 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.

Objective

To centrally test resected NSCLC for genetic mutations to facilitate accrual to randomized adjuvant studies. To obtain clinically annotated tumor tissue and patient-matched non-malignant DNA from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow clinically annotated advanced genomic analyses in concert with the NCI Center for Cancer Genomics (CCG).

Treatment

Experimental: 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: Observation Patients (including patients previously randomized to placebo) undergo observation at least every 6 months for 2 years. Experimental: 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. Experimental: Nivolumab Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

Conditions

Lung

Phases

III

Therapies

Drugs

Age Group

Adult

Main Investiagtor

Vu, John

Practice

Lung

Scope

National

Participating Institutions

Baptist MD Anderson Cancer Center; Baptist MD Anderson Cancer Center South

Eligibility

Eligibility Criteria: - Suspected diagnosis of resectable non-small cell lung cancer; cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus a "nonsquamous" histology; patients with squamous cell carcinoma are eligible only if the registering site has EA5142 Institutional Review Board (IRB) approved - Suspected clinical stage of IIIA, II (IIA or IIB) or large IB (defined as size >= 4 cm); Note: IB tumors < 4 cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4 cm; the 7th edition of American Joint Committee on Cancer (AJCC) staging will be utilized - Completely resected non-small cell lung cancer with negative margins (R0); patients with squamous cell carcinoma are eligible only if the registering site has EA5142 IRB approved - Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size >= 4 cm); Note: IB tumors < 4 cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4 cm; the 7th edition of AJCC staging will be utilized - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - No patients who have received neoadjuvant therapy (chemo- or radio-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 - Completely resected NSCLC with negative margins (R0); cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus a "nonsquamous" histology; patients with squamous cell carcinoma are eligible only if the registering site has EA5142 IRB approved - Pathologic stage IIIA, IIA or IIB, or large IB (defined as size >= 4 cm); Note: IB tumors < 4 cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4 cm; the 7th edition of AJCC staging will be utilized - Tissue available for the required analyses (either clinical tissue block or slides and scrolls) - In order to allow for time for central genotyping and eligibility for the ALCHEMIST treatment trial, patients must register within the following eligibility windows, depending on the adjuvant treatment approach: - If no adjuvant therapy, register patient within 75 days following surgery - If adjuvant chemotherapy or radiotherapy only, register patient within 225 days following surgery - If adjuvant chemotherapy and radiation, register patient within 285 days following surgery

Nct ID Number

NCT02194738

Secondary Trial ID Number

A151216

Keywords

Screening

More Information

clinicaltrials.gov

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