Clinical Trials Logo
  1. Home
  2. Gastro-Intestinal Cancer
  3. NCT05848843

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Status Withdrawn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
View Details
See also
  Status Clinical Trial Phase
Completed NCT03918538 - A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors N/A
Recruiting NCT05078918 - Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors N/A
Active, not recruiting NCT04548830 - Safety of Lung Cryobiopsy in People With Cancer Phase 2
Completed NCT04633850 - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05583916 - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05898594 - Lung Cancer Screening in High-risk Black Women N/A
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03575793 - A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer Phase 1/Phase 2
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Terminated NCT03275688 - NanoSpectrometer Biomarker Discovery and Confirmation Study
Not yet recruiting NCT04931420 - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels Phase 2
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Recruiting NCT06052449 - Assessing Social Determinants of Health to Increase Cancer Screening N/A
Not yet recruiting NCT06017271 - Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Recruiting NCT05787522 - Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk