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A Phase II Study of AMG 510 in Participants With Previously Treated Stage IV or Recurrent KRAS G12C Mutated Non-Squamous Non-Small Cell Lung Cancer (ECOG-ACRIN LUNG-MAP SUB-STUDY)

Primary Objective To evaluate the response rate (confirmed, complete or partial) of AMG 510 in participants with KRASG12C mutated Stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC). The response rates will be evaluated separately with cohorts defined as: i. Cohort 1 (co-mutation with TP53): Presence of TP53 mutations AND Wild Type STK11, KEAP1, NFE2L2, AND CUL3. ii. Cohort 2 (co-mutation with STK11): Presence of STK11 co-mutations AND Wild Type TP53, KEAP1, NFE2L2, AND CUL3. iii. Cohort 3 (all others): All participants not eligible for Cohorts 1 and 2 will be included in Cohort 3. Note that this includes participants with dual co-mutations in STK11 and TP53; co-mutations in KEAP1, NFE2L2, CUL3, or others; or lack of any co-mutations. Secondary Objectives a. To evaluate investigator assessed progression-free survival (IA-PFS) within each cohort. b. To evaluate overall survival (OS) within each cohort. c. To evaluate duration of response (DOR) among responders within each cohort. d. To evaluate the frequency and severity of toxicities within the full study population (all cohorts combined). Translational Medicine Objectives a. To evaluate the association between clinical outcomes (response, IA-PFS, OS) and other co-mutations (e.g., CDKN2A/B/C, ATM, PIK3CA) identified by the FMI FoundationOne CDx from LUNGMAP, within cohorts and across the full study population of KRASG12C positive participants. b. To evaluate the association between clinical outcomes (response, IA-PFS, OS) and PD-L1 total proportion score determined by screening in LUNGMAP, within cohorts and across the full study population of KRASG12C positive participants. c. To evaluate the association between clinical outcomes (response, IA-PFS, OS) and Tumor Mutational Burden Score determined by the FMI FoundationOne CDx from LUNGMAP, within cohorts and across the full study population of KRASG12C positive participants. d. To collect, process, and bank cell-free deoxyribonucleic acid (cfDNA) at pre-treatment on cycle 1 day 1, cycle 2 day 1, cycle 3 day 1, and at progression for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor DNA (ctDNA) and association with clinical outcomes. Note: The translational medicine proposal to use these specimens will be submitted as a revision to CTEP for approval, prior to the SWOG Statistical and Data Management Center (SDMC) review of assay results.

Primary Objective To evaluate the response rate (confirmed, complete or partial) of AMG 510 in participants with KRASG12C mutated Stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC). The response rates will be evaluated separately with cohorts defined as: i. Cohort 1 (co-mutation with TP53): Presence of TP53 mutations AND Wild Type STK11, KEAP1, NFE2L2, AND CUL3. ii. Cohort 2 (co-mutation with STK11): Presence of STK11 co-mutations AND Wild Type TP53, KEAP1, NFE2L2, AND CUL3. iii. Cohort 3 (all others): All participants not eligible for Cohorts 1 and 2 will be included in Cohort 3. Note that this includes participants with dual co-mutations in STK11 and TP53; co-mutations in KEAP1, NFE2L2, CUL3, or others; or lack of any co-mutations. Secondary Objectives a. To evaluate investigator assessed progression-free survival (IA-PFS) within each cohort. b. To evaluate overall survival (OS) within each cohort. c. To evaluate duration of response (DOR) among responders within each cohort. d. To evaluate the frequency and severity of toxicities within the full study population (all cohorts combined). Translational Medicine Objectives a. To evaluate the association between clinical outcomes (response, IA-PFS, OS) and other co-mutations (e.g., CDKN2A/B/C, ATM, PIK3CA) identified by the FMI FoundationOne CDx from LUNGMAP, within cohorts and across the full study population of KRASG12C positive participants. b. To evaluate the association between clinical outcomes (response, IA-PFS, OS) and PD-L1 total proportion score determined by screening in LUNGMAP, within cohorts and across the full study population of KRASG12C positive participants. c. To evaluate the association between clinical outcomes (response, IA-PFS, OS) and Tumor Mutational Burden Score determined by the FMI FoundationOne CDx from LUNGMAP, within cohorts and across the full study population of KRASG12C positive participants. d. To collect, process, and bank cell-free deoxyribonucleic acid (cfDNA) at pre-treatment on cycle 1 day 1, cycle 2 day 1, cycle 3 day 1, and at progression for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor DNA (ctDNA) and association with clinical outcomes. Note: The translational medicine proposal to use these specimens will be submitted as a revision to CTEP for approval, prior to the SWOG Statistical and Data Management Center (SDMC) review of assay results.