IRB Study Number A151216
Status Recruiting
Institute Taussig Cancer Institute
Description
2.1 Primary Objectives
2.1.1 To centrally test resected NSCLC for genetic mutations 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 Genomics (CCG).
2.2 Secondary Objectives
2.2.1 To characterize the natural history of molecularly characterized NSCLC 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, and PD-L1 immunohistochemistry (IHC) with a central reference standard.
Inclusion Criteria
3.1 Patient Pre-registration Eligibility Criteria
Sites should enroll patients on A151216 only if the patient is planning to register to one of theALCHEMIST treatment trials (A081801 and E4512).
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 IIA, IIB, IIIA or IIIB (T3-4N2). The 8th edition of 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 IIA, IIB, IIIA or IIIB (T3-4N2). The 8th edition of AJCC staging will be utilized.
For all patients
• ECOG Performance Status 0-1
• Age ≥ 18 years
• No patients who have received neoadjuvant therapy (chemotherapy, targeted therapy, or radiotherapy) 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 years 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 pre-registration.
3.2 Patient Registration Eligibility Criteria
• Tissue available for the required analyses (either clinical tissue block or slides and scrolls, see Section 5.1)
• 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 IIA, IIB, IIIA or IIIB (T3-4N2). The 8th 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 77 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.
Exclusion Criteria
Exclusion Criteria Not Available
