Phase 1b/2, Open-Label, Multicenter Study of ERAS-007 in Combination with Other Anti-Cancer Therapies in Patients with Advanced Non-Small-Cell Lung Cancer (HERKULES-2)

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Details
Age

Adult

Eligibility

SUB-STUDY A -- - NSCLC with the following features: a. Histologically or cytologically confirmed NSCLC b. Advanced NSCLC not amenable to curative surgery or radiotherapy c. Measurable disease per RECIST v1.1 Note: Any lesions that have been treated with loco-regional therapies (eg, radiotherapy, surgery etc.) should not be considered measurable, unless they have clearly progressed since the therapy. Previously treated lesions that have not progressed should be considered non-measurable and therefore, assessed as non-target lesions. d. EGFR mutation(s) sensitive to EGFR inhibitors at initial diagnosis per local approved label SUB-STUDY B -- - NSCLC with the following features: a. Histologically or cytologically confirmed NSCLC b. Advanced NSCLC not amenable to curative surgery or radiotherapy c. Measurable disease per RECIST v1.1 Note: Any lesions that have been treated with loco-regional therapies (eg, radiotherapy, surgery etc.) should not be considered measurable, unless they have clearly progressed since the therapy. Previously treated lesions that have not progressed should be considered non-measurable and therefore, assessed as non-target lesions. d. Presence of KRASG12C mutation i. For Part B1, Part B3, Part B5, and Part B7 (dose escalation), molecular testing for KRASG12C status to be determined locally with an analytically validated assay in a certified testing laboratory ii. For Part B2, Part B4, Part B6, and Part B8 (dose expansion), molecular testing for KRASG12C status will be performed centrally on archival or freshly collected tumor tissue in advance of enrollment. A KRASG12C central testing result is required prior to enrollment.

Type of Study

Treatment

Locations

CTRC Inpatient
Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Tejas Patil,  MD

Tejas Patil, MD

Study ID

Protocol Number: 21-4032

More information available at ClinicalTrials.gov: NCT04959981

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