Non-Small Cell Lung Cancer (NSCLC)

Developers will now initiate the phase 3 MarsLight-11 trial of IBI363 among patients with immunotherapy-resistant squamous non–small cell lung cancer.

The confirmed ORR was 40.0% in cohort 1A and 66.7% in cohort 1B of patients treated with sacituzumab tirumotecan/tagitanlimab for advanced NSCLC.

Prior data from the STRESS-LUNG-1 trial introduced emotional distress as a “psycho-biomarker” for immunotherapy efficacy in non–small cell lung cancer.

Findings from the KRYSTAL-12 trial support adagrasib as a treatment option for those with disease progression on prior chemotherapy and immunotherapy.

Zenocutuzumab offers a targeted treatment for NRG1+ lung and pancreatic cancers, demonstrating promising efficacy and manageable adverse effects.

The drug that the companion diagnostic identifies patients for, zongertinib, received FDA approval for HER2-mutant NSCLC on August 8, 2025.

Zongertinib is now approved by the FDA for patients with nonsquamous NSCLC with HER2 TKD activating mutations.

Panelists discuss how dose modifications for ALK inhibitors can significantly improve quality of life issues like brain fog and weight gain while maintaining disease control, emphasizing the importance of multidisciplinary team support including palliative care from diagnosis.

Following the approval of dato-DXd in untreated EGFR-mutant NSCLC, Jacob Sands, MD, discussed next steps for improving outcomes for this disease.

Jacob Sands, MD, discussed considerations for EGFR-mutant non–small cell lung cancer following the approval of dato-DXd in this disease.

Nonrandomized phase 2 data support further assessment of aumolertinib among patients with NSCLC and brain metastases in a randomized clinical trial.

A combined cohort composed of patients from the TROPION-Lung01 and TROPION-Lung-05 trials showed a survival advantage with dato-DXd vs docetaxel.

Panelists discuss how proactive monitoring for ALK inhibitor adverse effects through regular lipid panels, liver function tests, and patient education about red flag symptoms like bradycardia or cognitive changes enables early intervention and successful dose management.

Osimertinib/chemotherapy and amivantamab/lazertinib have exhibited an efficacy advantage vs osimertinib in patients with EGFR-mutant NSCLC.

Panelists discuss how the unprecedented 5-year progression-free survival benefit (60% vs 8%) demonstrated in the CROWN trial supports starting with the most effective treatment (lorlatinib) upfront rather than sequential therapy approaches.

The treatment combination elicited partial responses in 80% of patients with squamous NSCLC and 46% in nonsquamous NSCLC.

Panelists discuss how treatment selection between lorlatinib and alectinib for ALK-positive non–small cell lung cancer should consider both efficacy data favoring lorlatinib and patient-specific factors like neuropsychiatric history or cardiovascular comorbidities that might favor alectinib.

Panelists discuss how a 48-year-old fitness instructor with ALK-rearranged stage IV lung cancer and bone metastases was successfully treated with alectinib, experiencing manageable adverse effects while returning to modified teaching activities.

The agency’s decision is based on results from the phase 1 RMC-6291-001 clinical trial evaluating elironrasib monotherapy in patients with solid tumors.

Support for the regulatory decision follows data from a phase 1/2a clinical trial assessing the agent in EGFR-mutant NSCLC at the 2025 ASCO Annual Meeting.

Investigators will present updated findings from the phase 3 FLAURA2 trial at a future medical meeting.

Panelists discuss how managing amivantamab-related adverse events like leg edema requires understanding of underlying mechanisms (hypoalbuminemia) and may benefit from albumin infusion, dose holds, or consultation with specialists for severe cases like infected scalp wounds.

Panelists discuss how the COCOON study's advanced dermatologic prophylaxis protocol, including systemic antibiotics and topical treatments, can reduce skin toxicities by 50% in patients receiving amivantamab plus lazertinib therapy.

Particularly strong efficacy signals were observed in patients with non-squamous non–small cell lung cancer previously treated with PD-1 inhibition.

Panelists discuss how comprehensive patient education about expected adverse effects, combined with prophylactic measures including dexamethasone premedication and dermatologic support, helps patients successfully tolerate amivantamab plus lazertinib therapy while maintaining treatment adherence.