NCI Community Oncology Research Program - Protocol Summary
Alliance A151216 - "Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)"
The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
Please contact NCORP-KC for complete protocol information.
Lung Clinical Trial
CANCER TYPE: Non-Small Cell - Stage I
RESEARCH BASE: Alliance A151216
NCT NUMBER: 02194738
HIPPA FORM: DOWNLOAD HIPPA FORM
Consent Form: VIEW CONSENT FORM
UPDATED ON 01/30/2019 (16:30:14)
NSC, Stg IB, II, or IIIA, resectable, no neo-adjuv chemo or RT; Study of Enrichment Marker Identification & Sequencing (EGFR & ALK genotyping). DCP-001 Eligible
1) Sites must submit tissue block or slides for EGFR/ALK testing to Response Genetics, Inc. (RGI). RGI will forward leftover tissue block directly to the NCI CCG Biospecimen Core Resource (BCR). Sites that submit slides to RGI must send tissue scrolls to BCR.
2) All pts will pre-register to A151216. Post-op pts will complete registration at the same time as pre-regist. Pre-op pts will be pre-registered, and then registered following surgery if all eligibility criteria have been met.
Treatment Plan (Supplied Drug: N/A)
Pts may be either pre-op or post-op. If pre-op, FFPE block is collected at surgery.
FINAL ELIGIBILITY REVIEW
If Ineligible ---> Pt not registered & will not be followed
If Eligible ---> REGISTRATION
FFPE tissue submitted for EGFR & ALK genotyping at RGI & research genomics at BCR. Results sent to sites w/i 14 business days. EGFR+ &/or ALK+ pts will be assessed for the adjuv tx trials, Alliance A081105 or CTSU E4512.
Cohort A: Central EGFR or ALK complete & enrolling in either Alliance A081105 or CTSU E4512
No follow-up on this study. Use Alliance A081105 or CTSU E4512 follow-up plan. If recurrence, send tissue from bx to BCR.
Cohort B: Central EGFR or ALK testing complete (but not enrolled on adjuvant trial) & FFPE tissue submitted for research genomics
Follow-up on this trial q 6 mos x 5 yrs. If recurrence, send tissue from bx to BCR.
Cohort C: Central EGFR & ALK testing incomplete & incomplete FFPE tissue submitted for research genomics
End follow-up when notified by Alliance.
- Clinical Stg IB (>4cm), II, or IIIA non-squamous, NSCLC.
- ECOG perf status 0-1.
- No prior neo-adjuv chemo or RT.
- Patients may be receiving adjuvant chemotherapy at the time of registration.
- Age >18.
- No prior or current malignancies w/i past 5 yrs, except non-melanoma skin cancer or in situ carcinomas.
- No prior tx w/agents targeting EGFR mutation or ALK rearrangement.
- Patients with local genotyping are eligible, regardless of the local result.
- No pregnant or lactating women.
- PRE-REGIST REQUIREMENTS:
- Tissue block or slides for EGFR/ALK testing to RGI*
- Whole blood (for matched germline control)
- Signed informed consent.
- Completely resected non-squamous NSCLC.
- Path-staged IB >4cm or IIA-IIIA.
- Adequate FFPE tissue for central EGFR & ALK genotyping, including those already identified to carry eligible EGFR or ALK alterations.
* RGI will forward leftover tissue block directly to BCR. Sites that submit slides to RGI must send tissue scrolls to BCR.