ALCHEMIST

Introduction to ALCHEMIST PDF
A151216 Screening Trial PDF
A081105 PDF
E4512 PDF

ALCHEMIST The Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials, or ALCHEMIST, are a group of randomized clinical trials for patients with early-stage non-small cell lung cancer (NSCLC) whose tumors have been completely removed by surgery. For patients with early-stage NSCLC, there is a 50% chance that the cancer will come back, even after patients receive standard treatment. The ALCHEMIST trials test to see if adding targeted therapy based on patients' tumor genetics will help prevent the cancer from returning and therefore increase the number of people who may live longer. The targeted therapy would be in addition to and after the patient completes the usual standard of care treatment.

A151216: A screening trial for A081105, E4512 and EA5142.

Primary Objectives:  To centrally test resected NSCLC for genetic mutations to facilitate accrual to randomized adjuvant studies.

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

Secondary Objectives: 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.

To cross-validate local genotyping assays for EGFR and ALK with a central reference standard.   

For more information on this study and if you may be eligible to participate, please refer to the ALCHEMIST Patient Information on this website or by calling the study coordinator at 906-225-6995.

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.

Primary Objectives: To assess whether adjuvant therapy with erlotinib will result in improved overall survival over placebo for patients with completely resected stage IB-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy.

Secondary Objectives: To assess whether adjuvant therapy with erlotinib will result in improved disease free survival over placebo for patients with completely resected stage IB-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy.

To evaluate the safety profile of erlotinib in the adjuvant setting.

To assess whether adjuvant therapy with erlotinib will result in improved disease free survival rate at 2 years, and overall survival rate at 5 and 10 years over placebo for patients with completely resected stage IB (≥ 4cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy.

To assess the primary and secondary objectives in all randomized patients, regardless of central confirmation of the EGFR mutant status.

For more information on this study and if you may be eligible to participate, please refer to the ALCHEMIST Patient Information on this website or by calling the study coordinator at 906-225-6995.

E4512: Fusion Protein A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK).

Primary Objectives: To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival over placebo for patients with stage IB ≥ 4cm, II and IIIA, ALK-positive NSCLC following surgical resection.

Secondary objectives: To evaluate and compare disease-free survival associated with crizotinib and placebo.

To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting.

To collect tumor tissue and blood specimens for future research.

For more information on this study and if you may be eligible to participate, please refer to the ALCHEMIST Patient Information on this website or by calling the study coordinator at 906-225-6995.

EA5142: Adjuvant Nivolumab in Resected Lung Cancers – A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in NonSmall Cell Lung Cancers

Primary Objectives: To evaluate whether adjuvant therapy with nivolumab will result in improved overall survival and/or disease-free survival over standard observation in patients with Stage IB≥4cm, II and IIIA, non-small cell lung cancer following surgical resection and standard adjuvant therapy.

Secondary Objectives: To evaluate the safety profile of nivolumab when given as an adjuvant therapy.

To evaluate and compare disease free and overall survival in patients with tumors that express PD-L1 in various patterns associated with nivolumab and standard observation.

To evaluate and compare disease free and overall survival in patients with tumors that have high mutational load associated with nivolumab and standard observation.

To evaluate overall survival and disease free survival by stage.

To evaluate overall survival and disease free survival by each stratification factor.

To evaluate the proportion of patients alive and progression free at 1 year, 2 years, and 5 years.

For more information on this study and if you may be eligible to participate, please refer to the ALCHEMIST Patient Information on this website or by calling the study coordinator at 906-225-6995.