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Status:

ACTIVE_NOT_RECRUITING

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)

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Stage IB Lung Non-Small Cell Carcinoma AJCC v7

Stage II Lung Non-Small Cell Cancer AJCC v7

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 ce...

Detailed Description

PRIMARY OBJECTIVES: I. To centrally test resected non-small cell lung cancer (NSCLC) for genetic mutations to facilitate accrual to randomized adjuvant studies. II. To obtain clinically annotated tu...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 26 2014

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    September 28 2026

    Estimated Enrollment :

    8300 Patients enrolled

    Trial Details

    Trial ID

    NCT02194738

    Start Date

    September 26 2014

    End Date

    September 28 2026

    Last Update

    January 9 2026

    Active Locations (1663)

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    Page 1 of 416 (1663 locations)

    1

    University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, United States, 35233

    2

    Southern Cancer Center PC-Daphne

    Daphne, Alabama, United States, 36526

    3

    Southern Cancer Center PC-Mobile

    Mobile, Alabama, United States, 36607

    4

    Southern Cancer Center PC-Providence

    Mobile, Alabama, United States, 36608