Early results from stage I of the phase 3 PRESERVE-003 trial showed gotistobart improved overall survival versus docetaxel in previously treated metastatic squamous NSCLC. Objective response rate and duration of response also favored gotistobart, while progression-free survival did not differ significantly.
The phase III TOP study shows osimertinib plus chemotherapy more than doubles progression-free survival to 34 months versus 15.6 months with osimertinib alone in EGFR/TP53 mutant NSCLC. The combination achieved an 82.9% response rate and represents a new strategy for this high-risk subgroup. Research continues into resistance mechanisms, including cancer-associated fibroblasts' role in promoting osimertinib resistance.
Sacituzumab tirumotecan demonstrated a median overall survival of 20.0 months versus 13.5 months with docetaxel in pretreated EGFR-mutated NSCLC patients. The phase 2 OptiTROP-Lung03 study showed a hazard ratio of 0.63 for overall survival benefit with the TROP2-directed antibody-drug conjugate.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06206850 |
Neo-Bio-ADAURA: a Phase II Study to Evaluate Mechanisms of Resistance to Neoadjuvant Osimertinib |
RECRUITING | PHASE2 |
| NCT05782426 |
Study of Polymeric Micellar Paclitaxel, Platinum Combined With Sindilizumab Injection for Advanced Non-squamous NSCLC |
NOT_YET_RECRUITING | PHASE2 |
| NCT05751187 |
Pembrolizumab Plus Bevacizumab and Chemotherapy for Non-Squamous NSCLC Patients |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT05261438 |
Atezolizumab Plus Bevacizumab and Chemotherapy in First-Line Metastatic Nonsquamous NSCLC |
COMPLETED | |
| NCT04466917 |
A Study of ABP 215 Versus Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer |
WITHDRAWN | PHASE3 |
| NCT04447118 |
Phase 3 Study of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous NSCLC Harboring a HER2 Exon 20 Mutation Who Failed Platinum Based Chemotherapy |
COMPLETED | PHASE3 |
| NCT04413201 |
AFAMOSI: Efficacy and Safety of Afatinib Followed by Osimertinib Compared to Osimertinib in Patients with EGFRmutated/T790M Mutation Negative Nonsquamous NSCLC |
ACTIVE_NOT_RECRUITING | PHASE4 |
| NCT03755869 |
Study of Anlotinib in Non-squamous NSCLC Patients Who Failed First-Line（ALTER-L020） |
UNKNOWN | PHASE4 |
| NCT02454842 |
Study for Treatment With TH-4000 (Tarloxotinib) in Epidermal Growth Factor Receptor (EGFR) Mutant, T790M-negative Non-small Cell Lung Cancer (NSCLC) Patients |
TERMINATED | PHASE2 |
