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ACTIVE NOT RECRUITING

NCT02194738

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)

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

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.

Official title: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

7458

Start Date

2014-09-26

Completion Date

2027-09-21

Last Updated

2026-10-26

Healthy Volunteers

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

OTHER

Clinical Observation

Undergo observation

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

DRUG

Crizotinib

Given PO

OTHER

Cytology Specimen Collection Procedure

Undergo collection of blood and tissue

PROCEDURE

Echocardiography Test

Undergo ECHO

DRUG

Erlotinib

Given PO

DRUG

Gemcitabine Hydrochloride

Given IV

BIOLOGICAL

Nivolumab

Given IV

DRUG

Paclitaxel

Given IV

BIOLOGICAL

Pembrolizumab

Given IV

DRUG

Pemetrexed

Given IV

DRUG

Pemetrexed Disodium

Given IV

OTHER

Placebo Administration

Given PO

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Inclusion Criteria: * PATIENT PRE-REGISTRATION ELIGIBILITY CRITERIA: * For pre-surgical patients * 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 * 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 * 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); 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 * Age ≥ 18 years * 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 * Note: Post-surgical patients should proceed to registration immediately following preregistration * PATIENT REGISTRATION ELIGIBILITY CRITERIA: * Tissue available for the required analyses (either clinical tissue block or slides and scrolls) * Completely resected NSCLC with negative margins (R0); cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus a "nonsquamous" histology * 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 * Patients with squamous cell carcinoma are eligible only if they have not received adjuvant therapy * In order to allow for time for central genotyping and eligibility for the ALCHEMIST treatment trial, patients must register within the following eligibility windows: * Squamous patients: * No adjuvant therapy permitted, register patient within 77 days following surgery * Non-squamous patients: * 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

Locations (1660)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Southern Cancer Center PC-Daphne

Daphne, Alabama, United States

Southern Cancer Center PC-Mobile

Mobile, Alabama, United States

Southern Cancer Center PC-Providence

Mobile, Alabama, United States

Southern Cancer Center PC-Springhill

Mobile, Alabama, United States

Anchorage Associates in Radiation Medicine