Therapeutic responses in patients with advanced NSCLC enrolled in early-phase clinical trials at MD Anderson
Jeong Uk Lim1,2, Heather Y Lin3, Lei Kang1
1Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Abstract:
We evaluated clinical outcomes and safety profiles in patients with non-small cell lung cancer (NSCLC) treated in early-phase trials. A retrospective review of 546 NSCLC cases treated from January 2016 to December 2024 at The University of Texas MD Anderson Cancer Center was performed using the MD Anderson CHIMERA database. Patients were categorized into seven groups based on treatment regimen. The overall objective response rate (ORR) was 19.9%, and the highest ORRs were in the targeted combination (30.8%) and targeted monotherapy (29.7%) groups. Gene alteration-matched therapy, serum albumin level, metastatic burden, treatment group, and liver metastasis were independently associated with progression-free survival. For overall survival, albumin level, metastatic burden, liver metastasis, and treatment regimen group showed independent significant associations. While overall safety profiles were tolerable, combination regimens were associated with increased proportions of grade ≥3 adverse events and dose modifications.
Insights
This study on non-small cell lung cancer (NSCLC) found targeted therapies, especially combinations, improved response rates. However, combination regimens increased severe adverse events, highlighting a trade-off in NSCLC treatment.
Area of Science:
- Oncology
- Clinical Research
- Cancer Therapeutics
Background:
- Non-small cell lung cancer (NSCLC) remains a leading cause of cancer mortality worldwide.
- Early-phase clinical trials are crucial for evaluating novel treatment strategies in NSCLC.
- Understanding clinical outcomes and safety profiles is essential for optimizing patient care.
Purpose of the Study:
- To evaluate the clinical outcomes and safety profiles of patients with NSCLC treated in early-phase trials.
- To identify factors associated with progression-free survival (PFS) and overall survival (OS) in NSCLC patients.
- To compare the efficacy and safety of different treatment regimens.
Main Methods:
- Retrospective review of 546 NSCLC cases treated at The University of Texas MD Anderson Cancer Center from January 2016 to December 2024.
- Utilized the MD Anderson CHIMERA database for data extraction.
- Patients categorized into seven groups based on treatment regimen.
Main Results:
- Overall objective response rate (ORR) was 19.9%.
- Highest ORRs observed in targeted combination (30.8%) and targeted monotherapy (29.7%) groups.
- Gene alteration-matched therapy, albumin level, metastatic burden, treatment group, and liver metastasis were independently associated with PFS and OS.
Conclusions:
- Targeted therapies, particularly in combination or as monotherapy, demonstrate promising response rates in NSCLC.
- Serum albumin level, metastatic burden, and liver metastasis are significant prognostic factors for survival in NSCLC patients.
- While generally tolerable, combination regimens are linked to a higher incidence of severe adverse events and dose modifications, necessitating careful monitoring.
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