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Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO

Primary Objective To assess whether adjuvant therapy with erlotinib will result in improved overall survival (OS) over observation for patients with completely resected stage IB (4 cm)-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 (DFS) over observation for patients with completely resected stage IB (4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy, both overall and within the stage subgroups: IB and II/IIIA. To evaluate the safety profile of erlotinib in the adjuvant setting. To assess whether adjuvant therapy with erlotinib will result in improved DFS rate at 2 years, and OS rate at 5 and 10 years over observation for patients with completely resected stage IB (4cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy, both overall and within the stage subgroups: IB and II/IIIA. To assess the primary and secondary objectives in all randomized patients, regardless of central confirmation of the EGFR mutant status. To study detection of circulating EGFR mutations in cell-free plasma DNA as a prognostic marker in resected early stage NSCLC.

Primary Objective To assess whether adjuvant therapy with erlotinib will result in improved overall survival (OS) over observation for patients with completely resected stage IB (4 cm)-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 (DFS) over observation for patients with completely resected stage IB (4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy, both overall and within the stage subgroups: IB and II/IIIA. To evaluate the safety profile of erlotinib in the adjuvant setting. To assess whether adjuvant therapy with erlotinib will result in improved DFS rate at 2 years, and OS rate at 5 and 10 years over observation for patients with completely resected stage IB (4cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy, both overall and within the stage subgroups: IB and II/IIIA. To assess the primary and secondary objectives in all randomized patients, regardless of central confirmation of the EGFR mutant status. To study detection of circulating EGFR mutations in cell-free plasma DNA as a prognostic marker in resected early stage NSCLC.