Therapeutic responses in 555 advanced NSCLC patients enrolled in phase I studies at MD Anderson Cancer Center.

Abstract

8635 Background: Lung cancer remains the deadliest solid tumor, with non-small cell lung cancer (NSCLC) accounting for 80–85% of cases. Patients enrolling in Phase I studies are often heavily pretreated and face limited treatment options. Understanding their demographics and therapeutic responses is crucial to improving patient outcomes. This study aimed to analyze therapeutic responses in NSCLC patients enrolled in Phase I studies. Methods: Data on NSCLC patients treated at the Investigational Cancer Therapeutics (ICT) department, a dedicated Phase I unit at The University of Texas MD Anderson Cancer Center (MDACC), were reviewed from January 2016 to December 2024, using MDACC CHIMERA platform. Collected data included age, gender, histologic type, Eastern Cooperative Oncology Group (ECOG) performance status, prior lines of treatment, treatment regimen, trial details and best response to treatment. Results: A total of 555 NSCLC patients were identified, of whom 267 (48.1%) were female. The median age was 64 years. The number of prior chemotherapy lines included: one line (50.3%), two lines (16%), and three lines or more (11.0%). The most frequent histologic type was adenocarcinoma (80.0%), followed by squamous cell carcinoma (15.7%) and NSCLC not otherwise specified (3.1%). The median number of treatment cycles was three, and the median duration of treatment was 2.0 months. The best response was evaluable in 449 cases (80.9%). The overall objective response rate (ORR) was 21.2%, and the disease control rate (DCR) was 71.3%. Clinical trial enrollment were categorized into seven groups: Targeted Monotherapy (TM), 227 cases (40.9%); Targeted Combination (TC), 49 cases (8.8%); Immunotherapy Monotherapy (IM), 81 cases (14.6%); Immunotherapy Combination, 57 cases (IC) (10.3%); Targeted + Immunotherapy (TI), 70 cases (12.6%); Antibody-Drug Conjugates (ADC) Monotherapy, 64 cases (11.5%); and Others (O), 7 cases (1.3%). When the ORR was compared among these groups, the TM group demonstrated the highest ORR at 32.6%, followed by the O group at 28.6% and the TC group at 28.2%. Conclusions: Phase I studies, especially those involving regimens containing targeted therapy, may serve as a promising treatment option for pretreated patients with advanced NSCLC. Comparison of best response and objective response rates between different regimen groups. Targeted Therapy (Monotherapy) Combination with Targeted Agent Immunotherapy (Monotherapy) Combination with Immunotherapy Targeted Therapy Combined with Immunotherapy Antibody-Drug Conjugate (Monotherapy) Others P CR 1.6% 0% 0% 0% 0% 0% 0% <0.001 PR 31.1% 28.2% 4.7% 11.6% 10.5% 12.2% 28.6% SD 43.2% 59.0% 57.8% 44.2% 57.9% 65.3% 0% PD 24.2% 12.8% 37.5% 44.2% 31.6% 22.4% 71.4% ORR 32.6% 28.2% 4.7% 11.6% 10.5% 12.2% 28.6% <0.001 Abbreviations: CR: Complete Response; PR: Partial Response; SD: Stable Disease; PD: Progressive Disease; ORR: Objective Response Rate.