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Clinical Trials in Israel / NCT02194738
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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)

NCT02194738 · tracked via the Priya Life Science Israel tracker
Phase
Not applicable
Started
2014-09-26
Last updated
2026-09-23

Condition(s) studied

Stage IB Lung Non-Small Cell Carcinoma AJCC v7Stage II Lung Non-Small Cell Cancer AJCC v7Stage IIA Lung Cancer AJCC v8Stage IIB Lung Cancer AJCC v8Stage IIIA Lung Cancer AJCC v8Stage IIIA Lung Non-Small Cell Cancer AJCC v7Stage IIIB Lung Cancer AJCC v8

Investigational drug(s) / intervention(s)

Biospecimen CollectionCarboplatin →Cisplatin →Clinical ObservationComputed TomographyCrizotinib →Cytology Specimen Collection ProcedureEchocardiography TestErlotinib →Gemcitabine Hydrochloride →Nivolumab →Paclitaxel →Pembrolizumab →Pemetrexed →Pemetrexed Disodium →Placebo AdministrationPositron Emission Tomography

Biospecimen Collection: Undergo collection of blood samples

Carboplatin: Given IV

Cisplatin: Given IV

Clinical Observation: Undergo observation

Computed Tomography: Undergo CT or PET/CT

Crizotinib: Given PO

Cytology Specimen Collection Procedure: Undergo collection of blood and tissue

Echocardiography Test: Undergo ECHO

Erlotinib: Given PO

Gemcitabine Hydrochloride: Given IV

Nivolumab: Given IV

Paclitaxel: Given IV

Pembrolizumab: Given IV

Pemetrexed: Given IV

Pemetrexed Disodium: Given IV

Placebo Administration: Given PO

Positron Emission Tomography: Undergo PET/CT

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1660)

FacilityCityRegionStatus
University of Alabama at Birmingham Cancer Center Birmingham Alabama
Southern Cancer Center PC-Daphne Daphne Alabama
Southern Cancer Center PC-Mobile Mobile Alabama
Southern Cancer Center PC-Providence Mobile Alabama
Southern Cancer Center PC-Springhill Mobile Alabama
Anchorage Associates in Radiation Medicine Anchorage Alaska
Anchorage Radiation Therapy Center Anchorage Alaska
Alaska Breast Care and Surgery LLC Anchorage Alaska
Alaska Oncology and Hematology LLC Anchorage Alaska
Alaska Regional Hospital Anchorage Alaska
Alaska Women's Cancer Care Anchorage Alaska
Anchorage Oncology Centre Anchorage Alaska
Katmai Oncology Group Anchorage Alaska
Providence Alaska Medical Center Anchorage Alaska
Fairbanks Memorial Hospital Fairbanks Alaska
Banner MD Anderson Cancer Center Gilbert Arizona
Kingman Regional Medical Center Kingman Arizona
Cancer Center at Saint Joseph's Phoenix Arizona
Banner-University Medical Center Phoenix Phoenix Arizona
Mayo Clinic Hospital in Arizona Phoenix Arizona
Mayo Clinic in Arizona Scottsdale Arizona
Banner Boswell Medical Center Sun City Arizona
Banner University Medical Center - Tucson Tucson Arizona
University of Arizona Cancer Center-North Campus Tucson Arizona
Mercy Hospital Fort Smith Fort Smith Arkansas
CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas
CARTI Cancer Center Little Rock Arkansas
John L McClellan Memorial Veterans Hospital Little Rock Arkansas
Kaiser Permanente-Anaheim Anaheim California
Kaiser Permanente-Deer Valley Medical Center Antioch California
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California
PCR Oncology Arroyo Grande California
Sutter Auburn Faith Hospital Auburn California
Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California
AIS Cancer Center at San Joaquin Community Hospital Bakersfield California
Kaiser Permanente-Baldwin Park Baldwin Park California
Kaiser Permanente-Bellflower Bellflower California
Alta Bates Summit Medical Center-Herrick Campus Berkeley California
Keck Medicine of USC Buena Park Buena Park California

+ 1620 more sites — see the full list on the official registry below.

On this site

📄 Tarceva (erlotinib) drug profile → 📄 Opdivo (nivolumab) drug profile → 📄 Keytruda (pembrolizumab) drug profile →

More National Cancer Institute (NCI) trials in Israel

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02194738 on ClinicalTrials.gov ↗ ← All trials in Israel