ALLIANCE A151216: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST): A screening trial for A081105 and E4512.
2.1 Primary Objectives
2.1.1 To centrally genotype resected lung adenocarcinomas for EGFR mutations and ALK
rearrangements to facilitate accrual to randomized adjuvant studies.
2.1.2 To obtain clinically annotated tumor tissue and patient-matched non-malignant DNA from
peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow
clinically annotated advanced genomic analyses in concert with the NCI Center for Cancer
2.2 Secondary Objectives
2.2.1 To characterize the natural history of EGFR and ALK wild-type lung cancers to allow
subsequent development of targeted therapies against genotype-defined subpopulations in
the adjuvant and recurrent settings.
2.2.2 To cross-validate local genotyping assays for EGFR and ALK with a central reference
2.3 Exploratory/Other Objectives
2.3.1 To study the genomic evolution of lung cancers by comparing genomic characteristics at
resection and at recurrence.
- Rutgers Cancer Institute of New Jersey
- Principal Investigator
- Joseph Aisner M.D.
- Principal Investigator
- RWJBarnabas Health
- Community Medical Center
- Monmouth Medical Center
- Newark Beth Israel Medical Center
- Robert Wood Johnson University Hospital, Hamilton
- Robert Wood Johnson University Hospital, Somerset
- Saint Barnabas Medical Center, Livingston
- 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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria. For additional information on this trial or other available clinical trials please contact the research nurse.
For further information about clinical trials, please contact us at 732-235-7356.