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)

• Status: Recruiting
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Crizotinib; Gemcitabine; Nivolumab; Paclitaxel; Pembrolizumab; Pemetrexed

Criteria

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