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)

ID#: NCT02194738

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: August 18, 2014

End Date: September 28, 2021

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:

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

- 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