Clinical Trials

Inclusion Criteria:

• PATIENT PRE-REGISTRATION ELIGIBILITY CRITERIA:

• For pre-surgical patients

  • Suspected diagnosis of resectable non-small cell lung cancer
  • Suspected clinical stage of IIIA, II or large IB (defined as size ≥ 4cm)

• For post-surgical patients

  • Completely resected non-small cell lung cancer
  • Pathologic stage IIIA, II or IB (defined as size ≥ 4 cm)
• 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 prior or concurrent malignancies within 5 years, except non-melanoma skin carcinoma or in situ carcinomas; a secondary primary lung cancer is considered a concurrent malignancy and would make a patient ineligible for A151216
• No prior treatment with agents targeting EGFR mutation or ALK rearrangement
• Non-lactating and no patients known to be pregnant
• Patients who have had local genotyping are eligible, regardless of the local result
• Note: Post-surgical patients should proceed to registration immediately following preregistration
• PATIENT REGISTRATION ELIGIBILITY CRITERIA:
• Completely resected non-squamous NSCLC; eligible histologic subtypes include adenocarcinoma, adenosquamous carcinoma, or large cell/poorly differentiated non-small cell lung cancer (NSCLC) as long as squamous carcinoma is not favored; patients with pure squamous carcinoma are not eligible
• Pathologic stage IIIA, II, or large IB (defined as size ≥ 4 cm)
• Adequate formalin-fixed, paraffin-embedded (FFPE) tissue available for central EGFR and ALK genotyping for all patients, including those already locally tested for EGFR and ALK

• In order to allow for time for central genotyping and eligibility for the ALCHEMIST treatment trial, patients must register within the following eligibility windows, depending on the adjuvant treatment approach:

  • If no adjuvant therapy, register patient within 75 days following surgery
  • If adjuvant chemotherapy only, register patient within 165 days following surgery
  • If adjuvant chemotherapy and radiation, register patient within 225 days following surgery