(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
- Suspected diagnosis of resectable non-small cell lung cancer. Cancers with a histology of “adenosquamous” are considered a type of adeocarcinoma and thus a “nonsquamous” histology.
- Suspected clinical stage of IIIA, II or large IB (defined as size ≥4cm). Note: IB tumors <4cm are NOT eligible. Stage IB cancer based on pleural invasion is not eligible unless the tumor size is > 4 cm.
For post-surgical patients
- Completely resected non-small cell lung cancer with negative margins (R0).
- Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size ≥4 cm). NOTE: IB tumors <4cm are not eligible. Stage IB cancer based on pleural invasion is not eligible unless the tumor size is > 4 cm.
For all patients
- ECOG Performance Status 0-1
- No patients who have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancer
- Age ≥ 18 years
- 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 registatration.
- 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 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 ≥ 4cm). Note: IB tumors <4cm are NOT eligible. Stage IB cancer based on pleural invasion is not eligible unless the tumor size is > 4 cm.
- 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 or radiotherapy 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.