(ALCHEMIST) Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial
A screening trial for A081105 and E4512, and EA5142
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 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.
Treatment Plan
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.