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)
Study Phase: N/A
Recruitment Status: Recruiting
Start Date: August 18, 2014
End Date: September 28, 2021
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
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Conditions:
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung