For people ages 18 years and up
Key Eligibility Criteria:
- Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
- Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or blood from local testing.
- No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).
- Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months.
- Patients with asymptomatic CNS metastases are eligible.
- List of eligible PACC mutations:
E709X, E709A, E709H, E709V, E709K E709_T710delinsD, E709_T710delinsA, E709_T710delinsG, L718M, L718P, L718Q, L718V, G719X, G719A, G719C, G719D, G719S, G724S, E736K, I740_K745dup, I740_K745dupIPVAIK, I744_K745insKIPVAI, L747P, L747S, K757M, K757R, V765L, S768I, S768_V769delinsIL, S768_V769delinsIM, S768_V769delinsPL, V769L, V769M, N771G, H773_V774delinsLM, V774M, R776C, R776H, G779F, L792H, G796S, T854A, T854S, T854I, A647T, R675W, S768C, A755D, A750_I759delinsPN, T751_I759delinsN