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 follow the "Full Protocol" link or contact NCORP-KC for complete protocol information.
Lung Clinical Trial
CANCER TYPE: Non-Small Cell - Stage II
RESEARCH BASE: Alliance A151216
NCT NUMBER: 02194738
HIPPA FORM: DOWNLOAD HIPPA FORM
Consent Form: VIEW CONSENT FORM
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.
- For pre-surgical patients
- Suspected diagnosis of resectable non-small cell lung cancer.
- Suspected clinical stage of IIIA, II or large IB (defined as size ≥4cm)
- For post-surgical patients
- Completely resected non-small cell lung cancer.
- Pathologic stage IIIA, II or IB (defined as size ≥4 cm)
- For all patients
- ECOG Performance Status 0-1
- Age ≥ 18 years
- No patients who have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancer
- No prior or concurrent malignancies within 5 years, except non-melanoma skin carcinoma or in situ carcinomas. A secondary primary lung cancer is considered a concurrent malignancy and would make a patient ineligible for A151216.
- 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.
- PRE-REGIST REQUIREMENTS:
- Tissue block or slides for EGFR/ALK testing to RGI*
- Whole blood (for matched germline control)
- Completely resected NSCLC. Patients with squamous cell carcinoma are eligible only if the registering site has EA5142 IRB approved.
- Pathologic stage IIIA, II, or large IB (defined as size ≥ 4cm)
- Tissue available for the required analyses (either clinical tissue block or slides and scrolls, see Section 5.1)
- 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 only, register patient within 225 days following surgery.
- If adjuvant chemotherapy and radiation, register patient within 285 days following surgery.
* RGI will forward leftover tissue block directly to BCR. Sites that submit slides to RGI must send tissue scrolls to BCR.