NCI Community Oncology Research Program - Protocol Summary
Alliance A081105 - "Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)"
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 I
RESEARCH BASE: Alliance A081105
NCT NUMBER: 02193282
HIPPA FORM: DOWNLOAD HIPPA FORM
Consent Form: VIEW CONSENT FORM
NSC, Stg IB (>4cm), II, or IIIA, non-squamous, completely resected, prior regist to A151216 (ALCHEMIST); Erlotinib vs placebo. DCP-001 Eligible
Treatment Plan (Supplied Drug: Erlotinib / placebo)
RANDOMIZATION (Start w/i 14 days post-regist. Cycle = 21 days.)
Erlotinib: 150mg, PO, QD, x 2 yrs or until disease progression/excessive toxicity
Placebo: 150mg, PO, QD, x 2 yrs or until disease progression/excessive toxicity
- Prior regist to Alliance A151216, w/result of lung cancer EGFR exon 19 deletion or L858R mutation. Testing by 1 of following:
- Registered to A151216 & test performed centrally by protocol-specified lab.
- By local CLIA certified lab. These pts will also have been registered to A151216, but can be enrolled on A081105 regardless of central lab results.
- No known resistant mutations in EGFR TK domain (T790M). Pts both EGFR mutant & ALK rearrangements will be registered to A081105.
- Completely resected Stg IB (>4cm), II, or IIIA non-squamous NSCLC w/negative margins (by 7th ed of AJCC Cancer Staging Manual, 2010).
- Complete recovery from surgery and standard post-operative therapy (if required). Patients must be completely recovered from surgery at the time of randomization; the minimum time requirement between date of surgery and randomization must be at least 28 days, the maximum time requirement between surgery and randomization must be 90 days if no adjuvant chemotherapy was administered, 240 days if adjuvant chemotherapy was administered, and 300 days if adjuvant chemotherapy and radiation therapy was administered.
- Age >18.
- ECOG perf status 0-1.
- No history of cornea abnormalities.
- No prior or current malignancies w/i 5 yrs, except non-melanoma skin cancer or in situ cancers.
- No pregnant or nursing women.
- Granulocytes >1500/uL; platelets >100,000/uL; total bili,, SGOT, & serum creat each <1.5x ULN.
- PRE-STUDY REQUIREMENTS (Baseline screening exams & tumor msmt scan <42 days pre-randomiz. H&P, labs <16 days pre-randomiz.)
- PE, wt, BSA, perf status
- Pregnancy test (if applicable)
- Serum creat, BUN
- SGOT, alk phos, bili, albumin, Ca
- Chest CT (incl adrenals)
- Submission of tumor tissue & blood for genomic analyses on A151216 (ALCHEMIST trial)
- Signed informed consent.