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A Phase I Study of Adagrasib and Durvalumab for Treatment of Advanced Non-small Cell Lung Cancers and Gastro-intestinal Cancers Harboring KRAS G12C Mutations

Lung Cancer Clinical Trial

Official title:
A Phase I Study of Adagrasib and Durvalumab for Treatment of Advanced Non-small Cell Lung Cancers and Gastro-intestinal Cancers Harboring KRAS G12C Mutations

Clinical Trial Summary

To find a recommended dose of the combination of adagrasib and durvalumab that can be given to patients with cancers that have a KRAS G12C mutation.

Clinical Trial Description

Primary Objectives: • To determine the safety and tolerability, and to establish the recommended dose of the adagrasib and durvalumab combination in advanced NSCLC or GI cancer patients. Secondary Objectives: - To determine the objective response rate of the adagrasib and durvalumab combination for frontline treatment of advanced NSCLC harboring a KRAS G12C mutation. - To determine the objective response rate of the adagrasib and durvalumab combination for treatment of advanced CRC that have progressed on prior therapy with KRAS G12C inhibitors. - To determine duration of response (DOR) and progression-free survival (PFS) for the combination of the adagrasib and durvalumab in patients with advanced NSCLC harboring a KRAS G12C mutation. - To determine DOR and PFS for the combination of the adagrasib and durvalumab in patients with advanced CRC that have progressed on prior therapy with KRAS G12C inhibitors. Exploratory Objectives: - To assess predictive biomarkers of response and resistance to the combination of adagrasib and durvalumab. - To assess mechanisms of tumor cell adaptation upon treatment with the combination of adagrasib and durvalumab. - To determine mechanisms of acquired resistance to the combination of adagrasib and durvalumab. - To assess the effect of the combination of adagrasib and durvalumab on the immune tumor microenvironment. - To generate cell lines and patient derived xenograft (PDX) models from tumor samples. - To assess the anti-tumor reactivity of tumor infiltrating lymphocytes (TIL) from tumor biopsies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05848843
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Withdrawn
Phase Phase 1
Start date April 25, 2023
Completion date January 16, 2024
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