(ALCHEMIST) Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial
A screening trial for A081105 and E4512, and EA5142
Patient Pre-registration Eligibility Criteria
For pre-surgical patients
For post-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 all patients
- Completely resected non-small cell lung cancer
- Pathologic stage IIIA, II or IB (defined as size ≥4 cm)
- ECOG Performance Status 0-1
- No patients who have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancer
- Age ≥ 18 years
- No prior or concurrent malignancies within 5 years, except non-melanoma skin carcinoma or in situ carcinomas. A second primary lung cancer is considered a concurrent malignancy and would make a patient ineligible for A151216.
- No prior treatment with agents targeting EGFR mutation, ALK rearrangement, or 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
Patient Registration Eligibility Criteria
- Completely resected NSCLC, squamous or non-squamous
- Pathologic stage IIIA, II, or large IB (defined as size ≥ 4cm)
- Tissue available for the required analyses, either clinical tissue block or slides and scrolls
- 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 225 days following surgery.
- If adjuvant chemotherapy and radiation, register patient within 285 days following surgery.
Eligible patients will have tissue specimens submitted for EGFR and ALK testing (results available within 14 business days) and/or PD-L1 analysis (results available within 7 days for squamous patients and 21 days for non-squamous). For non-squamous patients, only those who are ALK and EGFR negative will have the PD-L1 testing done.
Patients with an EGFR mutation may register to the A081105 sub-study for treatment and follow-up.
Patients with an ALK rearrangement may register to the E4512 sub-study for treatment and follow-up.
Patients with negative EGFR and ALK results may register to the EA5142 sub-study for treatment and follow-up.