Non-Small Cell Lung Cancer (NSCLC)

Data from the Beamion LUNG-1 trial may help clinicians make informed decisions on HER2-targeted therapy for those with advanced or metastatic NSCLC.

All injections of JNJ-1900 have been completed according to plan so far in the phase 2 CONVERGE study, said Benjamin Cooper, MD.

Data from the PRESERVE-003 trial may support the use of a novel chemotherapy-free option for patients with squamous non–small cell lung cancer.

Data from the phase 1/2 ALKOVE-1 trial support the application for neladalkib in this non–small cell lung cancer population.

Data from the PALOMA-2 trial showed comparable efficacy with subcutaneous amivantamab vs prior reports of the intravenous formulation.

Patients with stage IIA to IIIA NSCLC identified as low risk per LAMPAD criteria may be candidates for treatment de-escalation with nivolumab.

Data from a phase 1 study may support combining KRAS inhibition with immune checkpoint inhibition in this NSCLC population.

Data from the phase 3 TOP trial support a potential molecular risk–guided treatment strategy for EGFR-mutant advanced NSCLC.

Low-grade toxicity related to durvalumab in the ASTEROID trial was common, which mostly consisted of skin reactions, pruritus, and fatigue.

Investigators are currently evaluating treatment with TRI-611 among patients with ALK-positive non–small cell lung cancer in a phase 1/2 trial.

Data from the SAMSON-II trial showed comparable PFS and OS outcomes with HD204 and reference bevacizumab among patients with nonsquamous NSCLC.

Treatment with sunvozertinib showed improvement across all secondary end points among those with EGFR exon 20 insertion mutation–positive NSCLC.

Although survival outcomes were comparable among the 3 PD-1 inhibitors in the overall cohort, tislelizumab and sintilimab showed superior PFS in PD-L1–positive subgroups, suggesting biomarker-driven therapeutic selection.

Based on an independent data monitoring committee’s feedback, enrollment for the phase 3 TACTI-004 trial will be halted.

Data from the REZILIENT1 trial support the NDA for zipalertinib for patients with advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations.

The agency highlighted regulatory compliance issues associated with a third-party facility referenced in the application for retifanlimab.

Updated findings from the eNRGy trial bring “hope” for managing rare molecular subtypes in non–small cell lung cancer, said Zhaohui Liao Arter, MD.

The FDA approved zongertinib in HER2-mutated NSCLC as part of its Commissioner's National Priority Voucher pilot program.

The new living guideline contains updated recommendations for biomarker testing and therapeutic strategies based on factors such as PD-L1 expression status.

Monthly dosing of subcutaneous amivantamab may confer consistent outcomes with the previously approved biweekly dosing schedule in EGFR-mutant NSCLC.

Pranshu Mohindra, MD, outlined considerations for optimizing the use of hypofractionated radiation for patients with lung cancer.

Investigators will share detailed results from the phase 3 LIBRETTO-432 trial assessing selpercatinib in NSCLC at a future medical meeting.

Early data from the KYANITE-1 study support the RMAT designation for KB707 as a treatment for those with advanced or metastatic NSCLC.

Infusing chemoimmunotherapy earlier in the day also correlated with improvements in responses among patients with NSCLC in a phase 3 trial.

The FDA has assigned a Prescription Drug User Fee Act date of November 14, 2026, for the ivonescimab-based combination.